Philips Acquires Medical Device Integration Platform Capsule for $635M

Philips Acquires Medical Device Integration Platform Capsule for $635M

What You Should Know:

– Philips announces the acquisition of Capsule, a leading vendor-neutral Medical Device Integration Platform with a software-as-a-service business model

– The Capsule acquisition is a strong fit with Philips’
strategy to transform the delivery of healthcare along the health continuum
with integrated solutions.


Philips, today announced that it has signed an agreement to acquire Capsule Technologies, Inc., an Andover, MA-based provider of medical device integration and data technologies for hospitals and healthcare organizations. Capsule’s Medical Device Information Platform – comprised of device integration, vital signs monitoring, and clinical surveillance services – connects almost all existing medical devices and EMRs in hospitals through a vendor-neutral system. Capsule’s platform captures streaming clinical data and transforms it into actionable information for patient care management to enhance patient outcomes, improve collaboration between care teams, streamline clinical workflows and increase productivity. 

Founded in 1997, Capsule is the leading global provider of medical device integration (MDI) and information solutions for healthcare providers. Capsule maximizes the value of live streaming medical device data by analyzing and synthesizing it across multiple sensors and devices attached to the patient to advance insight-driven, proactive care.

To date,
the company serves over 2,800 hospitals and healthcare organizations in 40
countries across the world. Capsule’s innovations are developed by strong
R&D teams in the U.S. and France. In 2020, the company achieved sales of
over USD 100 million with strong double-digit sales growth. The majority of
sales is related to recurring software-as-a-service and licensing revenues. The
acquisition will be accretive to Philips sales growth and Adjusted EBITA margin
in 2021.


Acquisition Underscores Philips Strategy to Scale Its
Patient Care Management Solutions

The acquisition of Capsule is a strong fit with Philips’
strategy to transform the delivery of care along the health continuum with integrated
solutions. Philips’ current portfolio already includes real-time patient
monitoring, therapeutic devices, telehealth, informatics and interoperability
solutions. The combination of Philips’ industry-leading portfolio with
Capsule’s leading Medical Device Information Platform, connected through
Philips’ secure vendor-neutral cloud-based HealthSuite digital platform, will
greatly enrich and scale Philips’ patient care management solutions for all
care settings in the hospital, as well as remote patient care. As part of the acquisition, Capsule and
its approximately 300 employees will become part of Philips’ Connected Care
segment.

“Integrated patient care management solutions supported by essential real-time patient data and AI are core to our strategy to improve patient outcomes and care provider productivity by seamlessly connecting care,” said Roy Jakobs, Chief Business Leader Connected Care at Royal Philips. “The acquisition of Capsule will further expand our patient care management offering. We look forward to integrating our strengths, adding a vendor-neutral medical device integration platform that further unlocks the power of medical device data to enhance patient monitoring and management, improve collaboration and streamline workflows in the ICU, as well as other care settings in the hospital and beyond its walls.”


Financial
Details

Philips
will acquire Capsule for $635M (approximately EUR 530 million) in cash. The
transaction is subject to certain closing conditions, including regulatory
clearances in relevant jurisdictions outside of the U.S. The transaction is expected to be completed in the first quarter
of 2021.

IoMT Is Improving Patient Access: We Must Avoid Creating New Barriers

The Internet of Medical Things (IoMT) is changing the face of healthcare and has the potential to significantly improve patient access as well as system efficiencies. The adoption of telemedicine, for example, spurred on by the Covid-19 pandemic, has spread rapidly.  Forrester revised its forecasts to predict that virtual care visits in the United States will soar to more than one billion this year—including 900 million visits related to Covid-19 specifically. Likewise, in the United Kingdom, 40% of doctor’s appointments now consist of phone or video calls.

Even before the pandemic, the adoption of IoMT was already growing rapidly, with the market valued at US$44.5 billion in 2018 and predicted to reach US$254 billion in 2026. There are more than 500,000 medical devices on the market, helping to diagnose, monitor, and treat patients – and more and more of these can, and are, becoming connected – not to mention innovations yet to enter the market. The connected medical devices segment specifically is expected to exceed $52 billion by 2022.

The COVID-19 Effect

The COVID-19 pandemic has changed the healthcare landscape more than any other single event in recent memory. The urgent and widespread need for care, coupled with the challenge of physical distancing, has accelerated the creation and adoption of new digital technologies as well as new processes to support their adoption and implementation across healthcare. The MedTech industry is emerging as a key apparatus to combat the virus and provide urgent support.

A simple example demonstrating the potential benefits of IoMT can be seen even within a hospital setting, where monitoring COVID-19 patients is costly in terms of time and PPE (personal protective equipment) consumption, since simply walking into a patient’s room becomes a complex process. IoMT technologies enable medical devices to send data to medical practitioners who can monitor a patient’s condition without having to take readings at the bedside. The same technologies can enable patients who do not require hospitalization to be safely monitored while remaining at home or in a community setting. 

From the patients’ perspective, many are embracing virtual healthcare as an alternative to long waits or having to go to a clinic or hospital altogether. And given the growing number and scope of connected medical devices and services, such as remote patient monitoring, therapy, or even diagnosis, there will be even more options in the future.  

Catalyzed by the pandemic, the IoMT genie is fully out of the bottle, and it is unlikely to go back. 

Increasing Access

This is good news for healthcare and good news for patients and families. Patient access is improving as telehealth, supported by connected devices to enable the collection of health-related data remotely, is helping to lift barriers. This increase in accessibility has the potential to improve the convenience, timeliness, and even safety of access to healthcare services for more people in more places. 

IoMT is lifting geographic barriers that have impeded access to healthcare since its very inception. Individuals with transportation or mobility challenges will no longer need to travel to receive routine care if they can be safely monitored while at home. Historically underserved rural or remote communities can gain access to medical specialists without needing to fly or drive great distances, while services can be delivered more cost-effectively. 

Furthermore, with fewer clinic or hospital-based appointments required for routine monitoring of patients who are otherwise doing well, doctors would be able to concentrate their in-person time and clinic resources on those most in need of care. 

The capacity for specialized medicine enabled by IoMT could also have a dramatic impact. The vast quantities of health data becoming available (with the requisite permissions in place), can enable sophisticated AI-driven health applications that can, for example, predict complications before they occur, better understand the health needs of specific populations, or enable stronger patient engagement and self-care. These models can also equip healthcare practitioners with better sources of information, ultimately leading to better patient outcomes.

Navigating Barriers

That said, while technology capabilities expand, innovation must take into consideration the needs of all the stakeholders within healthcare – from patients and caregivers to healthcare practitioners to administrators and payors/funders. Internet access, infrastructure, and comfort with technology, for example, can pose significant barriers for patients and health practitioners alike. 

One approach is to minimize the technological burden facing end-users. Devices should be user friendly and “ready to go” right out of the box, taking into consideration the circumstances and abilities of the potential range of users (patients and practitioners alike). Relying on the patient’s home Wi-Fi to provide connectivity is not ideal from either a usability or security perspective – not to mention availability and affordability. It is better for medical devices to have a cellular connection that can be immediately and securely connected to the network from any location, while also being remotely manageable to avoid burdening the user with network and setup requirements, or apps to download. 

Another barrier is the concern that both patients and healthcare providers have about security and data privacy risks. According to the 2016 edition of Philips’ Future Health Index, privacy/data security is second only to cost in the list of top barriers to the adoption of connected technology in healthcare across the countries surveyed.  

The Cybersecurity and Infrastructure Security Agency, FBI, and U.S. Department of Health and Human Services have warned of cybercrime threats against hospitals and healthcare providers. The WannaCry ransomware attacks affected tens of thousands of NHS medical tools in England and Scotland. The enthusiasm in rolling out new digital health solutions must not overlook security principles or create systems that rely on ad hoc patches.

One way of meeting the stringent security requirements of healthcare is to ensure that connected medical devices have security literally built into their hardware, following the most recent guidelines set out by the GSMA for IoT security, including the GSMA IoT SAFE specifications. In accordance with this globally relevant approach, connected devices have a specially designed SIM that serves as a mini “crypto safe” inside the device to ensure that only authorized communication can occur.

Similarly, new medical devices and software that are difficult to implement or cannot communicate with other systems such as electronic health/medical records risk being “orphaned” in the system or simply not used.  The latter is a matter of both developing the necessary integrations and ensuring the appropriate access and permissions are managed. More easily said than done, fully integrated systems take time, and some of the pieces may be added incrementally – the key is that the potential to do so is there from the beginning so future resources can be invested in enhancements rather than replacements. 

Early Collaboration is Key

Accessibility and usability must be designed right into IoMT solutions from the outset, and the best way of ensuring that is for developers and healthcare stakeholders to have plenty of interaction long before the product enters the market. Stakeholders are many and healthcare systems are complex, so innovators can look to startup accelerators and other thought leaders to help navigate the territory. The time and effort spent by innovators and healthcare stakeholders in collaborating is a sound investment in the future, ensuring that technology is designed and then applied in meaningful and equitable ways to address the most pressing issues. 

The telehealth genie, powered by IoMT, is indeed out of the bottle and is set to revolutionize healthcare. By ensuring that IoMT technologies are developed and implemented with security, accessibility, and ease of use for all stakeholders as priorities, we can make sure that the full benefits of this new dawn can be enjoyed by all. 


Heidi Sveistrup, Ph.D. Bio

As the current CEO of the Bruyère Research Institute and VP, Research and Academic Affairs at Bruyère Continuing Care, Heidi Sveistrup, Ph.D. is focusing on increasing the research and innovation supporting pivotal transitions in care; meaningful, enjoyable and doable ways to support people to live where they choose; and creating opportunities to discover and create new approaches to identify, diagnose, treat and support brain health with individuals with memory loss. Fostering new and supporting existing collaborations among researchers, policymakers, practitioners, civil society and industry continues to be a priority.


Elza Seregelyi Bio

Elza Seregelyi is the Director for the TELUS L-SPARK MedTech Accelerator program, which offers participants pre-commercial access to a secure telehealth platform. L-SPARK is currently working with its first cohort of MedTech companies. Elza has an engineering and entrepreneurship background with extensive experience driving collaborative initiatives.


New CMS rule to enable immediate coverage for FDA-designated ‘breakthrough’ devices

Medicare

The agency has finalized a rule that allows it to provide immediate Medicare coverage for FDA-approved products that are deemed “breakthrough devices.” The new coverage process would enable seniors to get access to these devices more quickly, but some provider and payer groups are concerned that this could cause patient harm.

The challenges of cybersecurity during global mass vaccination programmes

For many of us 2021 feels like a lot like 2020 with lockdowns imposed and hospital pressures increasing. However, there is light at the end of the tunnel with several vaccines now being rolled-out globally, says Dr Saif Abed, founding partner, AbedGraham.

Medtronic CEO expects to submit renal denervation data to FDA this year, overcoming previous failures

Medtronic suffered a shocking setback back in 2014 when its Symplicity 3 pivotal trial failed to meet its primary endpoint of reducing blood pressure meaningfully. Now it is gearing up to present new data to the FDA.

Push for better patient outcomes drives new standard of care [Sponsored]

heart, doctor, cardiac

In this webinar on Feb. 10,healthcare experts from Desert Oasis Healthcare and iRhythm Technologies will discuss how Zio monitors, designed to be worn for longer duration than holter monitors, represent a new standard of care in remote cardiac monitoring.

J&J and medical device innovation: the pharmaphorum podcast

In episode 27 of the pharmaphorum podcast I’m joined by Erin McEachren, who’s EU regional vice president at J&J Surgical Vision.

She talks about her priorities at J&J – having joined the company six months ago, the current state of the medical devices sector and some of the trends she’s keeping a close eye on.

Like pretty much every episode I’ve recorded since March this year the coronavirus features, and Erin tells me how she and her company have fared during the COVID-19 pandemic

There’s also time to hear about her time on the Canadian national skiing team and how competing at an elite level informed her subsequent business career.

You can listen to episode 27 of the pharmaphorum podcast in the player below, download the episode to your computer or find it – and subscribe to the rest of the series in iTunes, Spotify, acast, Stitcher and Podbean.

 

The post J&J and medical device innovation: the pharmaphorum podcast appeared first on .

Medical Device Design: 4 Ways Designers Can Create Medical Devices That Work for Everyone

Karten Design: Design Must Play a Larger Role in Healthcare
Stuart Karten, Founder/President, Karten Design

Medical device design has been going through sweeping
changes over the last decade.  Ten years ago,
medical device companies weren’t concerned with delivering consumer-level
design: Devices that are both attractive and intuitively easy to use by a wide
variety of users.  Then the Affordable Care
Act
was passed, and adherence and healthy behavior change became a
regulatory requirement.  

Our firm, which has been a long-time proponent of the
“consumerization” of medical product design, saw a steady uptick in business
based on our ability to deliver product experiences that a consumer expects
while also meeting regulatory requirements of the FDA.  And yet we still had to do a fair amount of
convincing to engineering teams about the importance of design that not only
works for physicians, but also makes life easier for caregivers and
patients. 

Our goal has always been to make design a priority for and
deliver great experiences to every voice in the ecosystem.  As tragic as COVID-19 has
been for millions of people, it has accelerated the consumerization of medical
device design:  the pandemic has
radically changed medical products for the better, forever. 

In the last six months, we have had many traditional device
companies and startups approach us to design COVID-19 testing products.  They want clinically effective medical
devices that are as easy to use as at-home pregnancy tests.  Companies are also coming to us with
non-COVID medical device ideas, and even the conversations around those
products have changed:  there is a
realization that medical devices must address a multi-layered audience. 

While all medical products must integrate the emotional,
physical and cognitive needs of the health consumer to create a holistic
experience, to really achieve consumer-level design companies need to go well
beyond human factors and useability studies and truly push the design
boundaries.  Medical device companies
that can’t integrate these four elements into their medical products are not
making scalable products, and will underachieve in today’s marketplace:

1. Improve Convenience:  Consumers today are accustomed to
convenience. We expect the world to operate at the speed of a Google search,
with the customizability of meal planning on sites like Plated or Blue Apron,
and the responsiveness of booking a ride on Uber. Healthcare rarely works this
way so a medical device must integrate it into the design.  In the medical world, the laws of consumer
design also apply:  with Axonics
Modulation Technology system, we
transformed
an innovative technology into a complete ecosystem of physical
and digital products that improve the experience and work hard in the background
to return normal daily lives to people suffering from incontinence.

2. Aim to Delight: 
Creating delight can transform an experience and build relationships
that keep customers engaged with your brand. 
Most medical solution providers look at users in terms of physical and
cognitive usability. But this is only the beginning. We believe there are four
additional dimensions that will help companies develop a qualitative
understanding of health consumers and their motivations—emotional, social,
contextual, and developmental. Exploring these dimensions at the front end of
the product development process will reveal what patients need and desire from
a health experience and enable companies to respond with meaningful innovation
that gains adoption and changes health outcomes.  We use these motivations to create delight in
the medical device.

3. Provide Personalized Experiences: Personalization
is a growing trend in the consumer product world, and it needs to become one in
healthcare. Those at the forefront are using data to make predictions that
anticipate customers’ needs and desires. Entertainment platforms, like Netflix,
make recommendations that introduce users to new content based on their
previous consumption. Virgin America’s in-flight screens address their
passengers by name and provide personalized information about their itinerary,
in addition to personalized dining and entertainment recommendations. In
healthcare, targeted, personal experiences can be a tipping point to meaningful
behavior change. Information has the power to engage health consumers in
moments where their decisions have a direct impact on their health and
wellbeing. With a majority of people carrying or wearing smart devices, it’s
possible to have continuous data about their location. This data can be used to
generate relevant, real-time recommendations. 
With COVID-19 or any future pandemic, real-time information can save
countless lives.

4. Be Emotional: 
The goal of consumer-driven product innovation is to create an emotional
connection between users and brands—a delightful experience or perception that
keeps people coming back. This is an important goal in healthcare as well, as
more complex factors start to influence choice, and continued engagement plays
a growing role in health outcomes. Although the medical product development
process is more burdened by engineering, technology, and regulation, medical
solution providers can adopt some best practices from consumer companies to
help their products connect. Consumer giants apply numerous resources toward
developing a deep understanding of their user. To capture health consumers’
interest and loyalty, it’s necessary for medical device makers to develop a
knowledge that goes deeper than a medical record or hospital survey. This
holistic understanding of consumers and their health journeys will breed
empathy—something that only comes from first-hand emotional transactions—and
help companies uncover many opportunities for meaningful innovation and
differentiation.


About Stuart Karten

Stuart Karten is the principal of Karten Design, a
product innovation consultancy creating positive experiences between people and
products specializing in health technology. 


3D Printing Makes Medical Devices More Personal

Personalized
medicine is a major trend in pharmaceutical R&D—and it’s transforming the
way we think of therapeutics. Unlocking the secrets of the genome has made it
possible to create treatments for disease that are more suited to the
individual. But personalized medicine isn’t a concept that only applies to drug
therapies. It is also highly relevant in the area of medical devices.

Many patients
depend on medical devices to help them recover from or manage diseases and
medical conditions. These devices can range from cranial implants to
pacemakers. And, as with one-size-fits-all therapeutics, even the best medical
devices have not always worked as hoped for every patient. However, the
personalized approach allows for tailoring certain devices to better serve the
individual.

Medical
devices and prosthetics

The advent of additive manufacturing (more commonly known as 3D printing) has been one of the key developments in enabling personalized medical devices. Previously, it wasn’t realistic to expect manufacturers to produce highly customized versions of one basic type of medical device. But 3D printing makes the process much quicker and more affordable, and can provide a design to fit the patient perfectly. ConforMIS custom knee implants, for instance, use 3D bone scanning and printing technology to produce the implant, even printing custom tools for the surgeon to use in the procedure.

3D printing is also helping to make prosthetics that are more effective and better suited to the patient. In a journal article published in Procedia CIRP, which includes a case study of a prosthetic arm, the authors wrote that: “Personalized medicine will allow for a reduction of rejection levels, an increase of patient’s quality of life and to a reduction or a delaying of downstream problems.”

Bioprinting

Although 3D printing actual human organs is still only a dream, it is not completely the stuff of science fiction anymore. The more delicate and still-developing version of 3D printing known as bioprinting is a process of recreating tissue for a patient. It involves using “bio-inks” and 3D printing techniques to print structures made of biomaterials and cells. In time, bioprinting could replace autografts. And, perhaps one day, people in need of an organ replacement will be able to turn to bioprinting rather than waiting for a donor match.

Models

3D printing is
also being used to create precise models, which is another way to make medicine
more personalized. A unique model replica of a patient’s organ can be used for
diagnostic purposes or to help doctors prepare for a surgery. Models like this
also have incredible implications for research. If researchers can use 3D
scanning and printing to replicate the organ of a particular type of patient
suffering from a particular type of cancer, for example, then they can study
that model to learn more and perhaps develop better personalized treatments.

3D Printing Makes Medical Devices More Personal

Personalized
medicine is a major trend in pharmaceutical R&D—and it’s transforming the
way we think of therapeutics. Unlocking the secrets of the genome has made it
possible to create treatments for disease that are more suited to the
individual. But personalized medicine isn’t a concept that only applies to drug
therapies. It is also highly relevant in the area of medical devices.

Many patients
depend on medical devices to help them recover from or manage diseases and
medical conditions. These devices can range from cranial implants to
pacemakers. And, as with one-size-fits-all therapeutics, even the best medical
devices have not always worked as hoped for every patient. However, the
personalized approach allows for tailoring certain devices to better serve the
individual.

Medical
devices and prosthetics

The advent of additive manufacturing (more commonly known as 3D printing) has been one of the key developments in enabling personalized medical devices. Previously, it wasn’t realistic to expect manufacturers to produce highly customized versions of one basic type of medical device. But 3D printing makes the process much quicker and more affordable, and can provide a design to fit the patient perfectly. ConforMIS custom knee implants, for instance, use 3D bone scanning and printing technology to produce the implant, even printing custom tools for the surgeon to use in the procedure.

3D printing is also helping to make prosthetics that are more effective and better suited to the patient. In a journal article published in Procedia CIRP, which includes a case study of a prosthetic arm, the authors wrote that: “Personalized medicine will allow for a reduction of rejection levels, an increase of patient’s quality of life and to a reduction or a delaying of downstream problems.”

Bioprinting

Although 3D printing actual human organs is still only a dream, it is not completely the stuff of science fiction anymore. The more delicate and still-developing version of 3D printing known as bioprinting is a process of recreating tissue for a patient. It involves using “bio-inks” and 3D printing techniques to print structures made of biomaterials and cells. In time, bioprinting could replace autografts. And, perhaps one day, people in need of an organ replacement will be able to turn to bioprinting rather than waiting for a donor match.

Models

3D printing is
also being used to create precise models, which is another way to make medicine
more personalized. A unique model replica of a patient’s organ can be used for
diagnostic purposes or to help doctors prepare for a surgery. Models like this
also have incredible implications for research. If researchers can use 3D
scanning and printing to replicate the organ of a particular type of patient
suffering from a particular type of cancer, for example, then they can study
that model to learn more and perhaps develop better personalized treatments.

Ensuring Telehealth Providers’ Virtual Care Dollars Make Sense

Ensuring Telehealth Providers’ Virtual Care Dollars Make Sense
Don Godbee Don Godbee, Mobile Solutions Architect at Stratix Don Godbee

Telehealth and virtual care are not brand-new phenomena suddenly cobbled together as a rapid response to the onset of the COVID-19 pandemic, but the average US patient could be forgiven for thinking that it is. Indeed, virtual visits to care providers and remote patient monitoring have been available for quite some time, delivering two key benefits: 

– Providing a platform to address cost-efficiencies and accessibility to quality healthcare for the populace at large 

– Playing a key role in managing a growing population of chronically ill seniors. 

Prior to 2020, however, the rules of reimbursement and implementation for associated telehealth services were difficult to navigate, wildly differing at the state and federal level with a host of regulations further complicating matters. Federal reimbursement policies are centered on Medicare, via the Centers for Medicare and Medicaid Services (CMS) – the single largest payer for seniors and chronically ill patients. Additionally, compliance with the Health Insurance Portability and Accountability Act (HIPAA) dictated rigorous standards for direct and monitoring communications between care providers and patients. Complicating matters further, US states offered a patchwork of individual telehealth laws dictating separate Medicaid policies. 

The result was a lack of clarity of how healthcare providers could overcome regulatory and financial reimbursement barriers to implement effective telehealth programs as well as a lack of parity in coverage services and payments for patients. To address this at the federal level, CMS released new guidance in 2020 to relax reimbursement restrictions for providers. Now, we’re at the cusp of a new era of telemedicine where providers could widely offer:

– Virtual office visits that address traditionally in-person services such as primary care, behavioral health, and specialty care (e.g. pulmonary or cardiac health rehabilitation)

– On-demand virtual urgent care to address pressing concerns and urgently needed consultations

– Virtual broader home health services such as remote patient monitoring, outpatient disease management, and various forms of therapy (e.g. physical, speech)

– Tech-enabled home medication administration helping patients receive injectable or consumable medication via monitored self-administration

This is all, of course, dependent upon the mobile technology (e.g. tablets, wearables, etc.) and associated services that telehealth providers will rely upon to make these services happen at parity and scale for their patients. Even more importantly, virtual care programs being scaled up to cover a larger percentage of patients will fall apart if providers don’t have the resources to offer robust support and maintenance options for these devices and services. Quality of virtual care is highly dependent on persistent device and service availability and dependability. 

Whether providers have already begun purchasing the mobile devices needed or are still struggling with the choice of what devices and services they need and/or can afford, however, they now face a different quandary: How to stand up these virtual care services at scale in a sustainable way that works within current budget resources and doesn’t pass on ballooning costs to your patients?

One way to make complex mobile technology deployments financially manageable is opting for a mobile device as a service (mDaaS) model which allows you to shift from a CapEx-based spending model to an OpEx spending model for purchasing hardware and allows telehealth providers to bundle or roll up a range of devices, accessories, services, maintenance and support into a single, predictable monthly per-device price. With mobile device technology rapidly evolving, telemedicine providers will need the operational agility to pivot to different solutions and quick technology refreshes as the need arises. 

When done with the right third-party partner, it offers the additional advantages of outsourcing end-to-end support and lifecycle management to highly trained agents, who can free up precious IT resources. Most importantly, it creates a level of control over technology and spend that makes standing up virtual care programs convenient and stress-free.

There are many options to consider when expanding telemedicine services rapidly to larger patient bases, whether during disruptive events such as the COVID-19 pandemic or in the years to come. The key to making these services sustainable is finding a financing model that will free up internal resources, offer greater spending flexibility, and offer end-to-end support for your healthcare mobile technology ecosystem. 


About Don Godbee Senior Mobile Solutions Architect at Stratix

Don brings a unique perspective to mobility in the Healthcare Vertical with over 25 years of consulting and delivery of critical solutions. Don has delivered various solutions from OEM integration of sensors in medical devices to mobile point of care solutions and services with major EHR software solution providers such as Epic, Cerner, GE Healthcare, Allscripts, and McKesson.

Israeli Digital Health Startup G Medical Innovations Withdraws $30M US IPO

Israeli Digital Health Company G Medical Innovations Withdraws $30M US IPO

What You Should Know:

– Israeli-based G Medical Innovation has withdrawn its plans for an initial public offering (IPO) on Tuesday, Nasdaq first reports.

– The company originally filed
an IPO to raise $30 million by offering 5 million shares at a price range of $5
to $7 last month to list on the Nasdaq under the symbol GMVD.

– The recent withdrawal marks the company’s second
attempt to go public in the US, previously filing in May 2019 and withdrawing
the following August. The company was also previously listed on the ASX (GMV)
but recently delisted its shares.

– G Medical Innovations is an early commercial-stage healthcare company developing app-based connected medical devices for vital signs monitoring. The company’s current product offerings include Prizma medical device, a clinical-grade device used to transform smartphones into medical monitoring devices, and Extended Holter Patch System, a multi-channel patient-worn biosensor that captures electrocardiogram data continuously for up to 14 days.

– The company reported $5M in revenue for the 12 months
ended June 30, 2020.

While We Wait for 5G, Is Wi-Fi or Cellular Better for RPM Solutions?

While We Wait for 5G, Is Wi-Fi or Cellular Better for RPM Solutions?
Mark Denissen, President and CEO, Anelto

Many in the healthcare industry are keeping an eye on the rollout of 5G wireless, which promises to connect people and things at higher speed and lower latency. In the healthcare realm, this means high-resolution images such as CT scans and X-rays can be taken and transmitted instantaneously to doctors. But it also means good things for lower-bandwidth applications, such as the volumes of rich data found in home healthcare applications. 

One of the beneficiaries of 5G will be remote patient monitoring (RPM), which helps seniors live independently and transforms their care. With RPM solutions, vital statistics such as blood pressure, oxygen level, blood glucose, weight, temperature, and other metrics are consistently monitored. Reliable connectivity is required to transmit data between the patient and the physician’s office or hospital. RPM solutions can also be two-way, with voice communications-enabled between doctors and patients. Some RPM solutions can also track data over time and spot abnormalities in readings such as low or high blood pressure or oxygen levels and can connect the patient to the doctor to explore solutions. The goal: Keeping patients healthy and allowing them to take a greater role in their healthcare.

By being able to take these vital signs at home and delivering them to their provider automatically and in real-time, the paradigm of care is shifted from episodic to preventative. This gives senior patients and their doctors much more flexibility in patient care and helps to reduce the need to visit the doctor’s office or hospital. With RPM, healthcare providers can:

– Speak in real-time with a patient who might not be feeling well

– Discuss a patient’s status and review their statistics in real-time

– Proactively care for patients so they don’t end up at the doctor’s office or emergency room 

– Intervene in the patient’s care to get their health back to normal

RPM solutions usually connect to the internet via WiFi or cellular. As we move towards 5G, which is the best solution to provide connectivity to RPM solutions?

WiFi

WiFi is the defacto home connectivity option for many people. It is relatively inexpensive, upload and download speeds have been consistently upgraded by service providers, and, in general, it works when needed. But it faces some challenges for home healthcare:

– Lack of ubiquity: According to Pew Research Group, as of 2019, only 59 percent of people over 65 have access to broadband connectivity at home. That makes it challenging to utilize WiFi in RPM solutions, which require a continuously reliable 24×7 data connection. 

– Limited ease of use: Wi-Fi can be strongly protected, but that protection comes at a price: the use of complex, multi-variable passwords and other configuration steps, which some seniors may struggle with. 

– Lack of 24/7 reliability: WiFi signals drop frequently. If Wi-Fi has a weak signal, loses power, or goes offline for another reason—even if it’s infrequently—it impacts the ability to deliver consistent patient results back to healthcare professionals—and vice versa. 

Cellular 

Cellular is a more reliable option for home care providers and the patients they serve. Some of the benefits of using cellular connectivity include:

Ubiquity: People understand how cellular works. For patients aged 65 and older, 91 percent own a cellphone and of those, 53 percent own a smartphone, according to Pew Research Group. 

Simplicity of set-up: For many RPM devices, complicated configuration is not required. While some solutions providers retrofit tablets, others have purpose-built RPM solutions that simply need to be turned on.

Consistent real-time data sets: Gathering data sets developed in real-time and over time allows healthcare providers to see trends and take preventative action. Cellular is a stronger fit for this type of application.

Upgrade path to 5G, when available: Some vendors are building 5G capabilities into their devices today to prepare for its arrival. RPM solutions that use cellular have a clear upgrade path to 5G’s high-bandwidth connectivity. 

The use of open standards and existing infrastructure. Cellular is well-proven, and RPM can use existing infrastructure as the underlying medium to connect patients and their healthcare providers and help patients take a greater role in their healthcare.

The ability to cover hundreds of devices simultaneously. Cellular macrocells are able to cover a wide area, ensuring connectivity is always available for the patient

Doctors and healthcare providers can now gather patients’ rich health data by including real-time and daily readings. This allows patients to get more involved with their care, assess situations in real-time, and speak with a physician when they are not feeling well, and generally to keep patients healthy and out of the doctors’ office or emergency room. RPM solutions are becoming increasingly easier to use and more feature-rich making connectivity choice imperative. Cellular connectivity will ensure solutions are available 24/7 to help keep seniors safe, and when 5G is more readily available at scale, there is a clear upgrade path for RPM solutions. 


About Mark Dennissen

Mark Denissen serves as the president and chief executive officer of Anelto. He has a storied career in the technology sector. Mr. Denissen worked for more than three decades with Texas Instruments (TI), serving in various roles before becoming the Vice President of Worldwide Strategic Marketing. In this role, he was responsible for the startup of businesses such as Medical Devices, LED lighting solutions, and motor control solutions. Additionally, he was responsible for the commercialization of breakthrough technologies developed in Kilby Labs, TI’s long-range research and development center, and worked directly with TI’s Chief Technical Officer to move numerous projects towards commercialization. He holds a BSEE degree from the University of California Los Angeles.

Medigate, Ordr Emerge as Leaders in Growing Healthcare IoT Market, KLAS Report Finds

Medigate, Ordr Emerge as Leaders in Growing Healthcare IoT Market, KLAS Report Finds

What You Should Know:

– As the buying wave of healthcare IoT solutions
continues, strong technology offerings and numerous new wins in the last year
have established Medigate and Ordr as leaders in the growing market.

–  KLAS finds that the adoption of security solutions for the healthcare internet of things (IoT) continues to grow as healthcare organizations look for ways to understand and manage the risk associated with connected devices.


The adoption of security solutions for the healthcare internet of things (IoT) continues to grow as healthcare organizations look for ways to understand and manage the risk associated with connected devices. In most deployments, the focus has shifted from securing mainly medical devices to covering both medical devices and the broader IoT devices found in healthcare settings.

KLAS Data Insights Report

As the market matures, organizations are also beginning to
look beyond core capabilities—where most solutions are comparable—to factors like
cost, ROI, expertise, and vendor culture when making buying decisions. With
many strong options in the market, the bar for vendors is high. In the
latest KLAS Data Insights report
, KLAS spoke with 51 healthcare
organizations to understand which vendors are being selected and why and to
glean early insights into customer satisfaction. Data insights for this report
comes from KLAS Decision Insights data and KLAS performance data.

Medigate, Ordr Emerge as Leaders in Growing Healthcare
IoT Market

As the buying wave of healthcare IoT solutions continues,
strong technology offerings and numerous new wins in the last year have
established Medigate and Ordr as leaders in the growing market. KLAS finds that
Medigate’s is picking up steam and showing rapid growth since last year. Medigate’s
technology delivers detailed information to customers through
device-fingerprinting capabilities.

Healthcare organizations that have recently selected Medgate
point to the vendor’s expanded IoT capabilities as an added plus in comparison
to being traditionally selected solely for medical devices. Healthcare organizations
that did not select Medigate cited concerns over price or challenges during the
sales cycle.

Customers who recently chose Ordr, whose market share has
consistently grown year over year, were drawn to the breadth and number of
devices Ordr can detect and the highly granular visibility the solution
provides. Feedback on the user experience is mixed, though customers say that
once users are properly trained, the tool drives deep insights. Ordr’s culture
of flexibility and willingness to partner stand out as reasons they are
selected. Prospective customers that did not select Order, cited other vendors as
having a deeper knowledge of medical devices.

Other key findings of the KLAS report include:

Palo Alto Acquisition of Zingbox Creates Uncertainty

Zingbox—acquired by Palo Alto Networks in fall
2019— was the early market leader as they continue to be considered in most
decisions, but a majority of prospective clients select other vendors, in large
part due to uncertainty about Zingbox’s future under Palo Alto Networks.

Concerns about Armis’ Technology Abilities Driven by
Sales Team

KLAS validated very few organizations that selected Armis. Cross-industry vendor Armis is increasingly considered in healthcare IoT security decisions; today, their traction in the healthcare industry is average.

Asimily and Up-and-Coming Sensato Leverage Healthcare
Expertise for Early Traction

Asimily has continued to grow and acquire customers in the last year as current customers see Asimily’s networking and healthcare expertise as differentiators. Healthcare organizations that select Asimily appreciate the vendor’s honesty about what they will and won’t do and how development requests fit into the product road map.

CyberMDX and Cynerio See Overall Slow Market Traction

– KLAS-validated considerations and new wins of
healthcare-focused vendors CyberMDX and Cynerio have been much lower than that
of most other commonly considered vendors.

For more information about the latest KLAS Data Insights
report, visit https://klasresearch.com/report/healthcare-iot-security-2020/1619

Johnson & Johnson Innovation Launches 3 Collaborations to Advance Healthcare in China

Johnson & Johnson Innovation Launches 3 Collaborations to Advance Healthcare in China
Front row (left to right): Jian Chen, Vice President, Xian Janssen Pharmaceuticals; Dan Wang, Head, Johnson & Johnson Innovation, Asia Pacific; Sharona Tao, Leader, Communications & Public Affairs, Johnson & Johnson China; Jennifer Yang, Head, Lung Cancer Initiative China, Johnson & Johnson Back row (left to right): Alex Zhavoronkov, Founder & CEO, Insilico Medicine; Li Peng, Assistant General Manager, Taikang Online Insurance; Gary Ge, Founder, Diannei

What You Should Know:

– Johnson & Johnson Innovation announces three strategic
collaborations with a focus on advancing healthcare solutions in China.

– The three strategic collaborations are focused on leveraging advances in science and technology to address areas of high unmet medical need across several areas, including discovery science, lung cancer, and medical devices


Johnson & Johnson Innovation, a division of Johnson & Johnson (China) Investment Limited, today announced three new collaborations with strategic partners in China. These latest collaborations, facilitated by the Johnson & Johnson Asia Pacific Innovation Center, showcase its broad innovation efforts and focus on leveraging advances in science and technology to address areas of high unmet medical need across several areas, including discovery science, lung cancer, and medical devices.

The collaborations are as follows:

1. Leveraging AI in drug discovery – Janssen Pharmaceutica NV, one of the
Janssen Pharmaceutical Companies of Johnson & Johnson, has established a
multi-target drug discovery collaboration with Insilico Medicine Hong Kong
Ltd., a Johnson & Johnson Innovation – JLABS @ Shanghai resident
company specializing in AI-based drug
discovery.

The agreement will leverage Insilico Medicine’s AI-based platform to design small-molecule hits with the defined properties for several targets nominated by Janssen. The collaboration aims to generate novel and fully patentable chemical scaffolds for difficult targets using AI-based drug designing, potentially leading to significant reductions in time and cost in identifying biologically active hits against selected targets.

2. Developing AI solutions for lung cancer detection
– The Lung Cancer Initiative at Johnson & Johnson in China,
through its affiliate Johnson & Johnson (China) Investment Limited, has entered
into a research collaboration with Diannei (Shanghai) Biotechnology Co. Ltd., a
Chinese company specializing in AI solutions for lung cancer management. The
agreement will see both parties work together to develop computer vision AI for
lung cancer diagnosis. Diannei’s expertise is in developing AI solutions with
deep learning for medical image analysis.

3. Innovative healthcare solutions for sports injury
– Johnson & Johnson Medical (Shanghai) Limited (JJMS) announced an
agreement with Taikang Online Insurance Co. Ltd. (Tk.cn), a Chinese online
healthcare insurance company, to develop an innovative sports injury-related
insurance package. JJMS will support Tk.cn by offering its industrial insights,
while Tk.cn designs reimbursement coverage to sports enthusiasts which aim to
enable timely diagnosis and appropriate surgical treatment for patients.

Why It Matters

“Johnson & Johnson has deep roots in China for the past 35 years to address the growing needs of patients and consumers. We are delighted to mark the third annual CIIE, a significant platform that supports the expansion, innovation and internationalization of the Chinese business environment, by announcing these new collaboration agreements,” said Will Song, Global Senior Vice President, China Chairman, Johnson & Johnson*. “These agreements span a diverse range of focus areas and represent a valuable opportunity to advance human health for the country by connecting global and local innovators with the expertise of the Johnson & Johnson Family of Companies to help transform great ideas into breakthrough solutions.”

KLAS Spotlight on Zoom for Healthcare Examines Early Outcomes

KLAS Spotlight on Zoom for Healthcare Examines Early Outcomes/Satisfaction
Source: Zoom

KLAS recently issued a Spotlight on Zoom for healthcare. KLAS Spotlights are first looks at new and emerging technology. Everyone knows Zoom, but how well does the solution perform for healthcare organizations looking to handle the immediate demands created by COVID-19 as well as develop long-term strategic initiatives? In this Spotlight, KLAS examines the early outcomes and satisfaction of some of Zoom’s healthcare customers.

Zoom Key Strengths & Challenges for Healthcare
Customers

Strengths

Works as promoted

–  Clients see value
in the solution

– Quick implementations, easy initial setup

Challenges

– Phone/web support less responsive due to extreme growth

– Lacks some bells and whistles other telemedicine products
may have

– Security is a concern for some  

KLAS outlines four key points to ponder for healthcare
organizations considering Zoom:

1. The Solution’s Long-Term Viability in Healthcare

In order to remain competitive in healthcare, Zoom will need
to improve the solution’s integration with EHRs and medical devices and also
make it easier for patients to connect to a telehealth session.

2. Impacts and Tradeoffs of the Underlying Technology

Zoom recently adopted Oracle Cloud and also maintains the
use of AWS and Azure cloud services. The mobile apps are developed in Java
(Android) and Swift (iOS). The Zoom environment accommodates both failover and
load-balancing services to support effective and reliable service response
times

3. Governance

Governance is a key factor in driving success with both
telehealth and teleconference capabilities. Guidance for how these capabilities
will be used internally and externally will need to be established.

4. Telehealth vs. Teleconference

Healthcare organizations require both telehealth and teleconference capabilities to effectively communicate with their staff and patients. Zoom must improve its enterprise application integration and medical device connectivity to compete in the exploding telehealth market.

For more information about the report visit https://klasresearch.com/report/zoom-health/1810

How Data-Driven Technology Holds The Promise of Better Outcomes for Vascular Patients

How Data-Driven Technology Holds The Promise of Better Outcomes for Vascular Patients

Abbott recently released global research on vascular patient care, designed to shine a light on the vascular patient journey. The report called “Beyond Intervention” uncovers the universal challenges faced by physicians who deliver vascular care, their patients, and the hospital administrators who support them. It also explores how the right use of technology and data could potentially enable more precise diagnoses and better treatment strategies to ensure the best possible patient outcomes. 

To establish what the state of vascular care looks like around the world today, Abbott surveyed over 1,400 patients, physicians, and health system administrators from nine countries. 

The research revealed how important personalized care is for patients. This was a sentiment that came through loud and clear from all the patients surveyed, regardless of geography. Patients desire more of a “tailored for me” approach from their physicians. This includes more face-to-face interaction and time with their doctor, with the ability to have all of their questions addressed.

Likewise, doctors sighted a scarcity of time spent with their patients as well as their limited visibility into patient adherence to treatment and lifestyle changes and challenges with other key factors that influence the quality of care they can provide.

What exactly does more personalized care look like? Here are some of the ideas that resonated with the vascular patients who responded to the survey:

– A consultative, two-way patient-doctor relationship, with the patient playing an active role in informed decision-making

– An individualized treatment plan based on the doctor’s ability to review relevant data pertaining to successes achieved with similar patients (“How did patients like me get better?”)

– Effective and seamless information-sharing among the primary care provider, hospital specialists, and healthcare systems, as well as with individual patients themselves via computer or smart applications.

– The ability for the doctor to monitor the patient’s progress remotely and provide information to verify that the personalized treatment is working, and to pick up early warning signs of relapse or deterioration

If more personalized care is what patients desire, then how can the use of technology and data enable this? We already see signs of this in the form of telemedicine and personalized care plans used to treat patients with chronic disease. We have also seen remote patient monitoring become a necessity and, in the age of COVID-19, a new standard of care, keeping patients “connected” with their physicians. This suggests that health care is moving in the right direction. Rather than simply treating the patient at a point in time for an illness, technology has the potential to harness the power of data to optimize care across the entire patient journey – before, during, and after the intervention. By focusing on the whole patient, and by placing him or her at the center of the healthcare world, providers can see beyond the intervention alone. 

The survey also revealed that hospital administrators’ top priority focused on patient satisfaction; successful outcomes that boost the number of satisfied and healthy patients while reducing hospital readmissions and costs. The results showed that administrators place a greater priority on plugging data gaps pertaining to outcomes than the total cost of care.

If the intention is to build data-driven technological solutions that see the whole patient, that could shift the focus from illness and intervention to wellness and prevention, potentially lightening the burden on providers, and delivering a higher quality of life for patients, also at a lower cost. 

The existing model of care is clearly not working to its full potential, to the detriment of everyone who must navigate it. But overhauling a healthcare system that is so entrenched in structure and institutional practices is not something that can happen overnight. Change will happen incrementally with the input of all stakeholders. It is up to us in the world of medical devices and technology to take our cues from the medical community, patient advocates, and healthcare systems big and small.

The research motivates us to continuously improve upon what we have already delivered and ask ourselves how we can make our products even better. Without knowledge of their pain points or insights into the challenges they face daily, we would not be able to effectively meet patients’ needs. This research also reinforces what Abbott is consistently striving to achieve: building life-changing technologies to improve the patient’s quality of life and help them live their best lives.

How Data-Driven Technology Holds The Promise of Better Outcomes for Vascular Patients

HP Launches EMR-Integrated Print Solutions to Digitize Point of Care Workflows

HP Launches EMR-Integrated Print Solutions to Digitize Point of Care Workflows

What You Should Know:

– HP launches patient-first print technologies to help healthcare
workers stay safe and spend more time caring for patients.

– Innovations co-developed with healthcare professionals
include industry’s first sterilizable printers, exclusive EMR-compliant
workflow solutions, and services to improve patient safety and privacy.


Today, HP Inc.
officially launched new print solutions for the healthcare industry. Based on
deep customer insights and co-developed with healthcare providers, associations
and partners, HP Healthcare Print Solutions address the most pressing issues
facing the healthcare industry today including patient wellness and safety,
care coordination, mobility, privacy and security. 

Reducing the Risk of Virus Transmission and Healthcare-Associated Infections 

HP’s new Healthcare Edition MFP keyboards and touch-enabled
control panels are designed to be disinfected regularly, withstanding up to
10,000X industry-standard germicidal wipes, helping to reduce the risk of
health-care associated infections (HAIs) and viral pathogen transmission. 
HP has further enhanced the disinfection capabilities of high-touch areas of
the printer with removable covers/drapes that can be sterilized daily in an
autoclave up to 134 ºC. HP is also collaborating with Clorox Healthcare to
offer a guide detailing infection prevention best practices and other
educational tools.

In order to enhance support of infection prevention
policies, HP has also broadened disinfection capabilities of HP Personal System
devices to include HP Engage Go3 and HP Elite products such as HP EliteDesks,
HP EliteOne (display panel only), ZBook Mobile Workstations and Z Series
Desktop Workstations, HP Elite and Z Displays (Z, S, E and P series, Display
Panel Only) and HP Education Notebooks (keyboards only) .

The U.S. Centers for
Disease Control (CDC) estimate
s that healthcare-associated infections
(HAIs) are responsible for 1.7
million infections and 99,000 associated deaths
each year. Infections and
viruses add further strains to healthcare organizations’ ability to provide
safe, quality care to patients. Influenza alone accounts for an US$11B economic
annual burden. Studies show commonly used technologies, like printers and
mobile devices, are often highly contaminated with pathogenic bacteria and
viral pathogens. Most IT and IoT devices were not designed to be regularly
cleaned by hospital-grade disinfectant wipes. Repeated use has shown to damage
the integrity of the plastic and, ultimately, the device itself.  

Minimizing Contact with Common Points of Transmission

HP’s unique global Managed Print Services (MPS) program with
Zebra Technologies provides the HP Advance mobile app on Zebra’s TC52-HC
handheld touch computer to enable care providers to minimize contact with
common points of infection transmission at the point of care. Providers can
walk up to any HP Healthcare Edition MFP, authenticate with the TC52-HC mobile
computer and release critical patient documents without having to touch the
device.    

Reducing the Risk of Electromagnetic Interference (EMI)

Patient and clinical worker mobile and IoT devices add to a
very congested radio spectrum that can interfere via electromagnetic
interference (EMI) with life-saving medical devices. The new HP Health
Solutions portfolio of IoT hand-held devices and IoT print devices are EN/IEC
60601-1-2 certified for EMI safety. The EN/IEC 60601-1-2 certification
ensures these devices can be used within the patient sphere and shared patient
areas without risk of EMI to sensitive patients and surrounding medical
equipment. 

Helping Ensure Positive Patient ID 

Patient identification errors are common and can lead to
serious reportable events that harm not only the patient’s health, but also the
clinical standing of the healthcare facility where such an error occurred. Together,
HP and Zebra solutions empower clinicians to better manage positive patient
identification through integrated color patient ID wristbands, trackable
specimen labels printed on-demand with Radio Frequency Identification (RFID)
location services and point of care identification solutions for patients.

Digitizing Processes for Faster, More Efficient Care
Coordination 

HP Healthcare Edition MFPs include the HP Workpath Biscom for Healthcare app fully integrated
with EPIC and Cerner. This
enables the entire clinical team to digitally transmit and receive patient
information and high-resolution color imaging like MRIs or directly input data
into the electronic
medical record (EMR)
system right from an app on the printer.  As a
result, care providers can make timely critical decisions to improve the
experience of patients and the entire care team and give back face time with
their patients. 

68% of physician respondents reported feeling burned out at
the moment, largely because of paperwork, regulatory demands and electronic
health record (EHR) documentation. Important pieces of healthcare data can fall
through the cracks, frustrating patients who don’t understand why a specialist
can’t see last week’s diagnostic test result or why they were not offered a
diabetic-friendly hospital menu while staying as an inpatient, for
example. 

Protecting Patient Privacy and Security

As the implementation of technology advances, so too are the
security threats against healthcare systems.  To help healthcare
organizations defend against emerging threats, HP provides the world’s most
secure PCs16 and printing solutions to protect patient privacy and sensitive
information. The new Healthcare portfolio also offers Basic Print Cloud
Services delivered through a service, HP Print Security Advisory Services and
HP Security Manager that provides patient data protection to all HP devices,
with the added protection of PrintSecure on Zebra wristband printers.

Availability

HP Healthcare Print Solutions are now available for direct
MPS customers in North America with plans to roll out across Europe and Asia in
2021.

Limbix digital therapeutic for adolescent mental health finds niche amid Covid-19 pandemic

The Silicon Valley startup plans to start its registration-directed study of Limbix Spark in the earlier part of next year and – if successful – would anticipate FDA clearance in early 2022.

Product Complaints & Recalls Virtual Summit

By having an effective complaint management system, life science organizations have a better chance to ward off inspections by using the appropriate guidelines and regulations. Monitoring complaint trends over time and having a complaint program improves the customer’s experience with your products.
Part of the process is being ready for anything, while a recall is a scenario we want to avoid, we need to be ready, we need to have a plan to go to, we need to learn how to mitigate and follow regulations. Register today for the Product Complaints and Recalls Virtual Summit and gain the critical knowledge needed to be prepared to excel when facing complaints and recalls, learn how to be proactive and not reactive.
Click here to learn more and take advantage of our discounted rates!

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PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team

PRISYM ID appoints Software Delivery Manager to oversee team developing new clinical labeling solutions  

 

Wokingham, United Kingdom — 30 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Amresh Bangalore as Software Delivery Manager.

In his new role, Amresh will be responsible for overseeing and coordinating the people, resources and processes required to deliver new solutions and upgrade existing products, primarily around the PRISYM 360 regulated labeling platform for clinical trials supplies and medical device manufacturers.

Amresh has joined PRISYM ID from Autino, where he was Software Development Manager tasked with delivering high quality software using Agile and SCRUM methodologies.

Prior to that, he worked for EBITS LLP as Software Development Manager for a team of developers and testers, and helped to implement and adopt Agile software development methodologies across the organization.

Other posts that Amresh has held include Technical Team Lead for the onshore and offshore development team at Medacs Healthcare.

Steve Grimison, SVP Global Development at PRISYM ID, commented: “As a leader in labeling software solutions for the Life Sciences and Medical Device industries, PRISYM ID is constantly evolving its products and services.

“We welcome Amresh who will play a critical role in helping us to achieve our goals by assisting the team responsible for developing new solutions and upgrades for our unique PRISYM 360 regulated labeling platform.  With his extensive and diverse experience in software development and delivery, he will be a valuable asset to the team.”

Pictured above: Amresh Bangalore, PRISYM ID Software Delivery Manager

Ends

Note to Editors: 

PRISYM ID provides regulated content and label management solutions designed specifically for life science companies and medical device manufacturers, improving patient safety and health outcomes whilst ensuring regulatory compliance. With a focus on medical device manufacturing and clinical trials supplies, PRISYM ID’s unique products and technologies are used to assure compliance globally, for 10 million+ medical devices and pharmaceutical products annually. www.prisymid.com

For more information:  

Andrew Baud, Distil, [email protected], +44 (0) 7775 715775

 

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J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]

In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector. 

Former KKR Vet Jim Momtazee Launches Healthcare Investment Firm, Patient Square Capital

Jim Momtazee and Maria Walker form health care investment firm Patient Square Capital
Jim Momtazee,
Managing Partner at Patient Square Capital

What You Should Know:

– Former KKR veteran Jim Momtazee announced the launch of
Patient Square Capital, a partnership being purpose-built to become the
preeminent investment firm in healthcare. 

– Patient Square will partner with best-in-class
management teams whose products, services, and technologies improve
health. 

– Prior to Patient Square, he spent over 21 years
at KKR, initially joining in 1996. He helped establish the firm’s health
care industry group in 2001 and subsequently was Head of the Americas Heath
Care Team for over 10 years.


Private equity veteran Jim Momtazee, today announced the
formation of healthcare investment firm, Patient Square Capital.  Patient
Square will partner with best-in-class management teams whose products,
services, and technologies improve health. The Patient Square team has a shared
vision to create an investment firm capable of managing large pools of capital
and with the expertise to meet the considerable and critical needs of the health
care world. 

Jim Momtazee Background

Mr. Momtazee is the Managing Partner of Patient
Square. He is a 21-year veteran of KKR, where he helped form its
Health Care Industry Group in 2001 and subsequently led the group for over 10
years.

In that role, he managed a team of over 20 dedicated health
care professionals overseeing five different health-care-related investment
strategies including private and growth equity.  He was a member of the
Americas Private Equity Investment Committee beginning in 2013 and was Chairman
of both the Health Care Strategic Growth and Health Care Royalty & Income
Investment Committees. 

Among the major health care investments made during Mr.
Momtazee’s tenure at KKR was Jazz Pharmaceuticals (2004); HCA (2006),
a $33 billion transaction which at the time was the largest cash buyout in
history; PRA Health Sciences (2013); and BridgeBio Pharma (2016). Mr. Momtazee
currently serves on the Boards of Directors of BridgeBio, PRA Health Sciences
(lead independent director), and the Medical Device Manufacturers Association.
He previously served on the Boards of Directors of Ajax Health, Alliance
Imaging, Arbor Pharmaceuticals, BrightSpring Health Services, Covenant Surgical
Partners, EchoNous, Entellus Medical, Envision Healthcare, Global Medical
Response, HCA, Heartland Dental, Jazz Pharmaceuticals, Lake Region Medical, and
Spirox.

Maria Walker to Serve as CFO

Mr. Momtazee is joined by Maria Walker, Partner & Chief
Financial Officer of Patient Square.  Ms. Walker has extensive experience
across private equity and health care, including 17 years at KPMG where she
served as a senior partner and a global lead in its private equity
practice.  

Patient Square Capital Investment Focus

Patient Square intends to build a distinctive and diverse
partnership with deep health care experience and a shared commitment to build a
world-class investment firm.  Patient Square will seek opportunities to
invest broadly across the healthcare industry, including technology-enabled
services, biopharmaceuticals, the pharmaceutical value chain, medical devices,
diagnostics, providers, digital health
and consumer health.


New Attacks, Regulations, and Stakes Call for New Security Strategies

New Attacks, Regulations, and Stakes Call for New Security Strategies
 Tim Callan, Senior Fellow, Sectigo

The amount of data generated by the healthcare industry is staggering—and constantly increasing.  Healthcare data encompasses the personal information of patients, doctors, nurses, and administrators. It includes diagnostic information, test results, ultrasound images, x-ray images, and of course insurance and financial information. With so much sensitive patient information there for the taking, it comes as little surprise that the healthcare industry—perhaps more than any other sector—has become a primary target for cyberattacks. Now, more than ever, it is critical that healthcare organizations take decisive action to protect their data. 

There has been no shortage of major (and notably costly) data breaches in recent years. The Equifax breach, for example, affected nearly half of all Americans. Last year’s Facebook breach was also headline news, thanks in large part to the number of users affected. Then there was a lesser-known yet costly LifeLabs breach—the largest in Canadian history—affecting more than 15 million people and prompting a lawsuit seeking north of $1 billion in damages for failure to adequately protect data. 

Healthcare data heists yield a premium, making them particularly attractive to hackers. The Center for Internet Security (CIS) notes that the “average cost of a data breach incurred by a non-healthcare related agency, per stolen record, is $158,” compared with $355 for healthcare records.

Though large, the LifeLabs incident isn’t even close to the largest healthcare data breach in history. That dubious honor goes to Anthem, which suffered a breach in 2015 that resulted in nearly 80 million compromised records. Although Anthem was able to reach a settlement with the victims for the relatively paltry sum of $115 million, both the standards for data protection and the expected remediation for failure have changed considerably in the five years since the attack. 

Regulations Raise the Stakes for Security

As the regulatory environment surrounding data breaches of all types grows more strict, hospitals and insurers have found themselves in the crosshairs of an increasingly brazen and sophisticated set of attackers. Part of the reason for this targeting stems from the relative value of healthcare records. There is a reason why “HIPAA” is an acronym known to most Americans, while other data protection laws are not.

Personal Health Information (PHI) tends to be more valuable than standard Personally Identifiable Information (PII) in large part due to its static nature. Patients can change a compromised credit card number or social security number, but not their medical history—and scammers prepared to exploit that history may render victims more vulnerable to certain types of fraud. 

New regulations are further raising the stakes for compliance. Although the California Consumer Privacy Act (CCPA) is not specifically targeted at healthcare organizations, the sector represents potentially one of the most vulnerable industries under the new law. If an organization is found to be in violation of CCPA, they have 30 days to rectify the situation or be subject to a fine of up to $7,500 per record exposed.

To put this in context: if CCPA were adopted nationwide, the LifeLabs breach that affected 15 million individuals would potentially be subject to a fine of $112.5 billion. That $1 billion lawsuits that LifeLabs is facing might sound like a lot, but under CCPA, it might mean getting off easy. This should underscore the necessity of protecting data of any kind today—let alone healthcare records. 

Ecosystems Span Email to Equipment

With the healthcare industry becoming an increasingly popular target and the penalties for breaches growing steeper, it’s important to consider that every endpoint, from desktops to devices, present attack paths for hackers. Measures as simple as stronger email security can make a big difference: in 2018 alone, Business Email Compromise (BEC) attacks resulted in more than $1.2 billion in victim losses. Spear phishing attacks, which are carried out using social engineering techniques to convince the target to relay confidential personal or financial information to what they believe is a legitimate recipient, represent an increasingly common method for attackers to gain access to user credentials or even directly obtain PII or PHI. Securing email with S/MIME (Secure/Multipurpose Internet Mail Extensions), which authenticates the sender of an email, enables employees not only to digitally sign and encrypt email communications but also to detect whether an email received has been authenticated or should not be trusted or opened.

Digital certificates are an essential part of protecting medical devices. Because they can be incorporated during the manufacturing process, these certificates allow device identity and integrity to be established from the moment they are first powered on. They also eliminate the potential for device spoofing, which protects against the possibility of counterfeit devices connecting to the network. These certificates serve as an effective proof point for savvy healthcare organizations. When vetting device suppliers and manufacturers, asking about their approach to device identity is essential. By learning to trust only manufacturers with a responsible approach to authentication, healthcare organizations can help protect one of the areas most susceptible to costly breaches. 

Medical equipment itself has also become more vulnerable. Today’s diagnostic devices are rarely standalone—most are connected to the internet, and anything connected to the internet can potentially be compromised. In fact, this compromise could occur before devices even leave the factory, potentially undermining even the most secure networks and leading medical device manufacturers to consider security starting at the assembly line; the point where device identity measures and digital certificate authentication become critical. Technologies such as secure boot can protect the integrity of a device or piece of software from the first time it is powered on. Similarly, embedded firewall and secure remote update technologies help ensure that software updates are authenticated before installation and that any communication with unauthorized devices stops before harm can be done. 

A kitchen with a sink and a window

Description automatically generated

Moving Forward with New Security Strategies

Today, health insurers, hospitals, and other patient care organizations must manage a truly massive amount of data. It is simply a fact of life. That data comes in many forms, and it can be valuable to cyber attackers for a multitude of reasons. At its core, this data is the healthcare industry’s most valuable asset—one that it must protect at all costs. 

Vulnerabilities can take many forms, from a human error to compromised devices. And while no solution can shield every possible form of attack, data and IT security administrators (and even OEMs) can take concrete steps to protect their organizations, patients, or chipsets against common attack vectors and better comply with today’s strict data protection regulations. Yes, the cloud has introduced new vulnerabilities, but it also has helped enable new security strategies and solutions that ensure every application, cell phone, server, or other connected “thing” has an authenticated digital identity.  The stakes are simply too high, and hackers have become too savvy, to rely on yesterday’s security status quo.

About Tim Callan, Senior Fellow at Sectigo

Senior Fellow Tim Callan contributes to the company’s standards and practices effort, industry relations, product roadmap, and go-to-market strategy. Tim has more than twenty years’ experience as a strategic marketing and product leader for successful B2B software and SaaS companies, with fifteen years’ experience in the SSL and PKI technology spaces.

Bodyport raises $11.2M, strikes partnership with Brigham and Women’s

Bodyport, a startup developing a scale intended to detect early signs of cardiovascular disease, raised $11.2 million in series A funding. The San Francisco-based company also struck a partnership with Brigham and Women’s Hospital.

Why MedCity News should be your go-to advertising partner

MedCity News has the most engaged healthcare business audience in the industry. We can collaborate with you to develop customized content or provide a platform for your business to present sponsored thought leadership content highlighting from executives in healthcare and life sciences.

Why Now Is The Time to Reimagine Healthcare Through Technology

The Tech Isn’t New – It’s Time to Embrace It (How Patient Comforts Improve All of Healthcare)
Jeff Fallon, CEO, eVideon

It wasn’t that long ago that people went to the bank on a Friday to cash their paper paychecks. Maybe they’d put some in checking and take some out in cash. They’d go to the grocery store over the weekend and maybe write one of those checks. Everyone always had to have a pen with them.

It wasn’t that long ago that people would call the ticket agent and discuss flight options for vacation. They’d send a paper ticket in the mail. When it was time to go, people would carry that ticket with them through the airport and onto the plane. (Of course, people could also keep their shoes on and could bring as much shampoo as their heart desired).

It wasn’t that long ago that if someone needed surgery, they’d have to call to schedule it. The hospital would call again the day before to tell them what time to come. People would travel there, fill out a bunch of paperwork, and be wheeled around to several different areas and talk to several different people. Eventually, they’d wake up post-surgery in a hallway with a bunch of other people and hopefully a family member. They’d wheel the person to their room where they’d have a small TV for entertainment, a dry erase board with some names on it and maybe the room number, and a stack of papers on the bedside table – cafeteria menus, instructions, important phone numbers and the like.

Oh wait – that time is now.

Better, more convenient systems are a no brainer for industries like banking and travel, but the hospital experience is still rife with paper handouts, basic cable packages, and manual dry erase boards with markers that don’t work half the time. Patients shouldn’t settle for that, and in this era when COVID-19 has led healthcare to embrace lots of other conveniences (like telehealth for remote doctors’ appointments), they won’t settle for it anymore.

Imagine a new kind of hospital room. While nobody should take a patient’s TV away, there’s so much more that can be done with patient TV. Most people have smart TVs in their homes that serve as a complete hub for their entertainment. Add a smartphone to the mix, and people can do nearly anything from their couch. A hospital bed should be no different.

Since EMRs became mandatory years ago, hospitals have relied on them as the source of truth for patient records and information. But EMRs paired with additional technology can do so much more. Now, hospitals can pull information from the EMR to personalize the patient experience. Imagine a hospital room TV greeting you by name with soothing music and welcoming imagery. Imagine the pillow speaker handset transforming into a smart TV remote where you can peruse movies on demand, live TV, or Netflix. Take it a step further – imagine that TV can talk to your EMR, so you can watch educational content just for you based on your condition, so you can learn about your care, treatment, and how to recover when you go home. 

Imagine adding more systems. Integrate dietary systems (in concert with the EMR) to let patients order their meals without sifting through paper and dialing phone numbers – as they do at home when they’re using DoorDash. Imagine letting patients dim the lights, request a blanket, or turn the thermostat up if they’re cold, without climbing out of bed and risking a fall. Imagine letting patients use their phones to input important information for the care team to know, or to video chat with a “visitor,” even during a pandemic when in-person visits aren’t allowed – even if the person on the other end doesn’t have a Zoom account or an iPhone for FaceTime.

Imagine never seeing a dry erase board in a patient room again. Instead, a digital display automatically updates with all the patient’s latest information, based on what’s in the EMR. 

Imagine up-to-the-minute precautions displayed instantly and digitally outside each patient’s room so care teams know what PPE they need before they go in.

Technology exists to do all these things. The early adopters are already seeing increased patient satisfaction scores that seem to consistently climb. Beyond that, especially now when nurse retention and preventing care team burnout are paramount, these technologies alleviate the burden on them. Streamlining, digitizing, and virtualizing all aspects of care and a patient’s time in the hospital benefits staff, too. When nurses don’t have to search all over to find markers that work or run back and forth to the printer to get pages of hand-outs for patients, they can spend more quality face time with patients and operate at top of license. 

When patient education is delivered in the right way, at the right time to the bedside, you’re not just saving printer paper – you’re giving patients the tools to succeed at home and avoid costly readmissions. It’s time to reimagine healthcare, and there’s no better time than now when the window to adopt new technology is wide open.


About Jeff Fallon

Jeff Fallon brings over 30 years of experience in healthcare technology, medical devices, pharmaceuticals, and diagnostics to eVideon as their Chief Executive Officer. Prior to joining eVideon, he helped distinguished organizations such as Johnson & Johnson and patient experience technology companies forge innovative strategic relationships and strategies.

Pre-filled Syringes San Francisco will now take place as a Virtual Conference

SMi Reports: Due to the ongoing challenges surrounding COVID-19 and large public gatherings, September’s Pre-filled Syringes San Francisco conference will now run as a virtual event.

With the continued uncertainty surrounding large gatherings in the UK, SMi Group have made the decision to turn the pre-filled Syringes Conference on the 14h – 15th September 2020 into a fully interactive virtual meeting.

All attendance by Pharmaceutical and Biotech companies will be free of charge and other delegates can join for only $499. Register online at http://www.prefilled-sanfrancisco.com/pharmapr8

This means the conference will go ahead as planned, with the full support of its speakers, sponsors and delegates, but will run live and online only on the SMi Virtual Conference Platform.

Benefits of SMi Group’s Virtual Conference Platform:

  • Live and On-Demand speaker content: Get online access to the latest strategies and case studies from your market
  • Network with all event attendees: Connect with delegates, speakers and sponsors in real-time and have your queries answered instantly
  • Exhibit & Visit a Virtual Booth: Set up your customized booth full of brochures, videos, and presentations
  • Host/Join Meetings & Socials: Join preferred speaking sessions, host your own meetings and even host virtual networking socials with the inbuilt Zoom functionality

 

The brochure including the full speaker line-up and programme details is available to download online at http://www.prefilled-sanfrancisco.com/pharmapr8

Pre-filled Syringes San Francisco
14TH – 15TH September 2020

Proudly sponsored by: Credence MedSystems | Mitsubishi Gas Chemical | PHC Corporation | Plastic Ingenuity | Steris | Sumitomo | Zeon Speciality Materials|

To sponsor or exhibit at the conference, please contact Alia Malick on +44 (0) 207 827 6748 or [email protected]

For media queries please contact Jinna Sidhu at [email protected] or call +44 (0)20 7827 6088.

–END—

About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk

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New speaker session with Kiniksa Pharmaceuticals at Pre-filled Syringes East Coast 2020

SMi Reports: new speaker session with Paul Roussel, Senior Director, Combination Products, at the Pre-filled Syringes East Coast 2020 conference

I am pleased to inform you that Paul Roussel, Senior Director, Combination Products, Kiniksa Pharmaceuticals, has confirmed his position as speaker at the conference.

Paul’s presentation is as follows:

Development of a Combination Product- A case study

  • What is a Combination Product
  • Considerations when developing a Combination Product
  • Development of Combination Products from the patient/human factors perspective
  • Advantages of working with outside development partners that offer platform systems
  • Lessons learned in developing combination products

Paul Roussel is currently a Senior Director of Combination Products at Kiniksa Pharmaceuticals in the CMC Technical Operations Group with over 20 years of experience in the drug delivery and medical device space. He completed his B.S. in Plastics Engineering and M.S. in Manufacturing Engineering.

Paul has extensive experience in the design, development, manufacture, and lifecycle management of drug delivery combination products, as well as expertise in the design and development of injection molding systems and high-speed assembly automation.

The brochure with the full agenda and speaker line up is available online at http://www.pfsamericas.com/pharmapr10

Sponsored by:

Almac | Aptar Pharma | Bold insight | CSS | Credence MedSystems | Mitsubishi Gas Chemical | PHC Corporation | Polyplastics-Topas | Steris | Weiss-Aug | Zeon Speciality Materials | Zwick Roell |

Contact Information:

For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: [email protected]

–END—

About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk

The post New speaker session with Kiniksa Pharmaceuticals at Pre-filled Syringes East Coast 2020 appeared first on .

Indigo raises 38 million euros for ‘invisible’ diabetes glucose sensor

Medical device company Indigo Diabetes has raised 38 million euros to develop an “invisible” sensor for people with diabetes, which could provide an alternative to the “patch” based monitors currently on the market.

The new investment round will enable Indigo to prepare and start up the clinical study phase for the device.

Indigo hopes that the device could one day be an alternative to the continuous glucose monitoring devices that usually sit on the skin with a visible patch.

Indigo’s device is a small sensor chip designed to be inserted underneath the skin and continuously measure glucose and ketones in people with diabetes.

The Belgian company says the chip is the first of its kind in the world, enabling the faster detection of life-threatening situations by both the users and their healthcare providers.

At the same time, the invisible sensor aims to give patients a substantially improved quality of life.

The funding round was led by Fund+, with the participation of Ackermans & van Haaren, imec.xpand, Capricorn Digital Growth Fund, QBICII, Titan Baratto.

The company received support from the investors of a Series A capital round, led by Thuja Capital Healthcare Fund II, PMV and Sensinnovat.

The funding will also drive further expansion of the company, which now has 25 employees. With the Series A round, Indigo Diabetes has raised over more than €45 million since 2016.

Initial investors Powergraph, Qbic Arkiv Fund, Fidimec, Manuardeo and Capricorn ICT Arkiv, also reinvested in the Series B capital round.

Indigo was founded by Belgian entrepreneur CEO Danaë Delbeke in 2016, who has also founded five companies based around photonics.

Photonic chip technology uses light instead of electricity, consuming relatively little power in the process.

Delbeke said: “It is our ambition to give people with diabetes control over their own lives again. By using nanophotonics – a spectrometer in miniature form – our sensor will allow us to measure glucose and other biomarkers or metabolites such as ketones accurately and continuously.

“Unlike the continuous glucose monitoring systems (CGMs) on the market today, our sensor will be invisible. The sensor will sit underneath and not on the skin. Diabetes therefore will no longer need to be visible.”

The post Indigo raises 38 million euros for ‘invisible’ diabetes glucose sensor appeared first on .

Who won the MedCity INVEST Pitch Perfect competition?

Question mark heap on table concept for confusion,

Healthcare startups across health services, health IT, medical devices, biopharma and diagnostics tracks took part in the week-long competition at the conference July 20-24. Here are the winners for the five tracks.

Telehealth and Cybersecurity: What You Should Know

New Telehealth Tablet Provides Clinical Collaboration Within Hospitals

Healthcare providers are seeing between 50 and 175 times (1) more patients via telehealth than before. Telehealth platforms* offer solutions for a wide array of different healthcare issues. An estimated 20 percent of all emergency room visits and 24 percent of routine office visits and outpatient volume could be delivered virtually via telehealth.

Telehealth is a win-win for providers and patients. It both increases the availability of care while also reducing costs. However, telemedicine does have intrinsic privacy and security risks that all providers must minimize to protect sensitive patient data.

The Inherent Vulnerability of Connectivity

Providers have been eager to adapt to this care delivery method, but many platforms do not meet HIPAA requirements and lack adequate data safeguards. The same connectivity that makes telehealth possible also creates threats to patients. Protecting patient health information (PHI) and providing remote services doesn’t fit together easily.

Any data transferred over the internet runs the risk of interception by threat actors, and healthcare has long been a preferred target for cybercriminals. In 2019, healthcare data breaches cost the industry over $4 billion (2). 

This year is no exception with a further increase in ransomware (3) and other attacks that put millions of patients’ records in danger of exposure. These types of events have all happened within typically well-fortified hospital networks.

Connecting with patients via telehealth and transmitting biometric data via remote care devices only furthers these dangers. The biggest risk is that patients lack control of the collection, usage and sharing of their PHI.

For instance, remote monitoring devices built with sensors to detect falls may collect information on other activities patients wish to be kept private—including that their home is unoccupied at certain times and the types of activity they participate in. Even with security measures, any transfer does have a potential for a breach.

How to Prevent Security Risks in Telehealth

More secure telehealth begins by establishing best practices. Because of the sensitive information healthcare organizations possess, providers and the vendors they choose to work with must focus on core elements of data security through related tools and strategies such as:

1. Identity Authentication

Continuous identity authentication ensures authorized individuals have access to data. Identity authentication can be accomplished through a variety of approaches.

Multi-factor authentication, or the requirement of utilizing two pieces of evidence to sign in, is among the most common and has been proven effective in blocking 99.9 percent of all automated cyber-attacks.

Beyond this, users need to develop strong, unique passwords for, not just their telehealth platform accounts, but across their entire online logins and accounts.

2. Improve Telehealth Platform Safety

HIPAA requires that providers integrate encryption and other safeguards into their interactions with patients. However, patients’ devices on the receiving end of care often don’t have these safeguards while some medical devices have been shown to be vulnerable to hackers.

Ensuring the safety of all patient devices in the short term will be impossible. Thus, telehealth platforms must be as secure in themselves as possible. The software needs to be designed in a secure environment and contain numerous ways of establishing secure channels between patients and providers.

3. Investing in Patient Education

Outside of telehealth, cybersecurity ultimately relies on the end-user. As hackers continuously exploit new vulnerabilities, developers are in a constant race to keep up with new threats. Cybersecurity is only as strong as its weakest link. Secure telehealth apps must be complemented by other measures.

For this reason, healthcare providers should educate patients about cybersecurity and the steps they should take to improve the overall safety of their interactions online by:

●  Educating patients about the telehealth security threats;

●  Using a VPN both during telehealth services and for general device usage;

●  Frequently updating all apps and operating systems, not just telehealth platforms;

●  Enabling anti-malware and virus scans to run at all times;

●  Restricting app permissions to what’s necessary for app functionality only; and

●  Recognizing social engineering and other types of cyber-attacks.

How to Minimize Telehealth Security Risks

The one word providers must focus on when implementing telehealth is encryption. It needs to be everywhere. Since data is vulnerable in all stages of its life cycle, including during storage, transmission and access, encryption must be built into every step of this process.

Concerns about the privacy and security of these systems should not adversely affect people’s trust in telehealth. The benefits outweigh the risks. But providers must embrace more rigorous standards and minimize threats to ensure telehealth can deliver on its promises and live up to its potential.

Sources:

  1. https://www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality
  2. https://healthitsecurity.com/news/data-breaches-will-cost-healthcare-4b-in-2019-threats-outpace-tech#:~:text=November%2005%2C%202019%20%2D%20Healthcare%20data,per%20each%20breach%20patient%20record.
  3. https://www.securitymagazine.com/articles/92575-increase-in-reports-of-ransomware-attacks-on-health-care-entities
  4. https://www.microsoft.com/security/blog/2019/08/20/one-simple-action-you-can-take-to-prevent-99-9-percent-of-account-attacks/

How can life science companies benefit from hiring a Professional Employer Organization? [Sponsored]

In an interview, TriNet’s Vice President of Life Sciences, Maria Abouseif, talked about the role Professional Employer Organizations play in helping life science companies navigate the COVID-19 public health crisis.

Featured speakers for 2nd annual Wearable Injectors and Connected Devices Conference

SMi Reports: Featured Speakers listed for SMi Group’s 2nd annual Wearable Injectors and Connected Devices Conference taking place in October.

The global wearable devices market size is expected to reach a value of $62.82 billion USD by 2025 with time dependent delivery, improved patient experience and adherence and large volume administration with minimal injection pain and being key factors driving the market.

With that in mind, SMi is proud to present Europe’s only Wearable Injectors Conference, taking place on the 7th-8th of October 2020, in London.

Interested parties can learn more and register at: http://www.wearable-injectors.co.uk/pharmapr3

Key speakers for this year’s conference include:                             

  • Julia Frese, Director, TÜV SÜD Japan ltd.
  • Digby Harris, Global Category Manager  – Medical Device development, AstraZeneca
  • Barbara Stollfuss, Team Lead Data Generation, Bayer Vital GMBH
  • Phil Tregunno, group Manager, MHRA
  • Blake Green, Senior Manager Regulatory Affairs, CMC Medical Devices, Amgen
  • Germano Meier, Project Leader, Device & Digital Solutions, Novartis
  • Solange Corriol-Rohou, Director, AstraZeneca
  • Cedric Gysel, Manager,  Healthcare Solutions Design, Johnson & Johnson
  • Megan Heft, Senior Device Engineer, AstraZeneca

2020 presentations Snapshot:

  • ‘Considerations for early technology evaluation and selection of large-volume, on-body injectors’ 
  • Megan Heft, Senior Device Engineer, AstraZeneca
  • ‘Application of wearable sensors to measure clinical benefitsGermano Meier, Project Leader, Device & Digital Solutions, Novartis
  •  
  • in OA patients’
  • ‘Design strategy for connected solutions: Driving better user experience’
  • Cedric Gysel, Manager,  Healthcare Solutions Design, Johnson & Johnson
  • ‘Enhancing patient administration experience for LVIs’
  • Blake Green, Senior Manager Regulatory Affairs, CMC Medical Devices, Amgen

Wearable Injectors and Connected Devices Conference will enable delegates to:

  • Explore the growing potential of connectivity and digital health to improve patient experience and treatment
  • Understand the key regulatory considerations in industry with representation from regulatory and notified bodies
  • Assess advances in device design and development for large volume delivery via on-body injectors
  • Gain insights into the use of wearable injectors and devices in clinical trials

To learn more about the conference and view the full agenda please visit:
http://www.wearable-injectors.co.uk/pharmapr3

Wearable Injectors and Connected Devices

7th – 8th October 2020

London, UK

Proudly sponsored by: Quantex-arc

 

— ENDS —

Contact Information:

For media enquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email:
[email protected]

About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk

The post Featured speakers for 2nd annual Wearable Injectors and Connected Devices Conference appeared first on .

A special presentation from J.P. Morgan for MedCity’s INVEST conference [Sponsored]

Pamela Aldsworth, head of VC coverage and managing director at J.P. Morgan, discusses deals and dealmaking during the pandemic and how startups can survive, in a special presentation to mark MedCity News’ annual INVEST conference.

Developing custom syringes for highly viscous formulations discussed at PFS San Francisco

SMi Reports: ‘Developing custom syringes for highly viscous formulations’ one of the many topics to be presented at the inaugural Pre-filled Syringes San Francisco Conference on September 14 and 15.

SMi Group is holding the inaugural Pre-filled Syringes San Francisco virtual conference, taking place on the 14th and 15th September 2020, in San Francisco, USA.

Who should attend:

  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers

To find out more about The Inaugural Pre-Filled Syringes San Francisco virtual conference please visit: http://www.prefilled-sanfrancisco.com/pharmapr7

The Pre-filled Syringes San Francisco Conference will be presenting a variety of topics, below are some key presentations:

‘Developing custom syringes for highly viscous formulations’

  • Gilead and West are developing a custom cyclic olefin polymer (COP) syringe to enable delivery of viscous formulations through subcutaneous injection needles
  • Due to the high injection forces required, syringe stresses and failure modes had to be well understood to inform design improvements
  • The final syringe design can withstand forces in excess of 500N, while remaining ISO 11040-6 compliant to facilitate fill/finish activities

Walter Goodwin, Device Engineer, Device Development & Clinical Packaging Engineering, Gilead Sciences

‘Connected devices and their potential to deliver user benefits’

  • What are connected systems of devices and why would a sponsor elect to develop a connected system
  • Potential benefits of connected devices and the trade-offs
  • Usability considerations of connected devices

Katie Atkinson, Manager, Human Factors Engineering, Bigfoot Biomedical

‘Post-Market safety reporting (PMSR) for combination products – Implementation’

  • Summary of implemented updates to the guidance for industry
  • Strategies in implementation of PMSR and its application to drugs and devices
  • Industry response and developments – what have we seen in industry already and what is still needed?
  • Case study: implementation of PMSR for a combination product

Khaudeja Bano, Senior Medical Director, Abbott Laboratorie

To register and see brochure with the full workshop agenda, and speaker line-up visit: http://www.prefilled-sanfrancisco.com/pharmapr7

Pre-filled Syringes San Francisco
14TH – 15TH September 2020

Hyatt Centric Fisherman’s Wharf, San Francisco

Proudly sponsored by: Credence MedSystems | Mitsubishi Gas Chemical | PHC Corporation | Plastic Ingenuity | Steris | Sumitomo | Zeon Speciality Materials|

For media queries please contact Jinna Sidhu at [email protected] or call +44 (0)20 7827 6088.

–END—

About SMi Group:

Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk

The post Developing custom syringes for highly viscous formulations discussed at PFS San Francisco appeared first on .

Medical Device CROs – The next Growth Opportunity

Over the past decade, numerous scientific and technological breakthroughs in the medical device industry have resulted in an accelerated pace of research and innovation within this domain. Further, the demand for high quality and efficient medical devices, driven by a growing geriatric population and increasing incidence of various chronic clinical conditions, is on the rise. However, one of the primary challenges faced by this industry is the complex and time-consuming product development lifecycle of a new medical device. Specifically, the clinical stage is exceedingly resource intensive, involving high costs and greater risks.Furthermore, new advancements have facilitated the development and enforcement of more informed regulatory guidelines and instructions to ensure the safety of medical devices. Subtle differences in regulatory guidelines across various geographical regions need to be considered by medical device developers in order to receive approval in different markets. This has further resulted in longer trials, higher costs (due to rise in patient enrollments), and increased time-to-market. In order to overcome the abovementioned challenges, medical device developers are actively outsourcing their clinical research and associated operations to specialized medical device CROs, which are known to have the required capabilities and expertise.

The medical device sector is one of the few businesses that has been relatively less impacted amidst the COVID-19 pandemic. Moreover, as the disease spreads, the demand for accurate diagnostic measures, medical devices (including handled scanners, and personal protective equipment (PPE)), and effective preventive and treatment solutions for COVID-19, is growing at a rapid pace. In this context, it is worth mentioning that the sales of handheld ultrasound / x-ray scanners and infrared thermometers have increased manifold, in compliance to social distancing guidelines. In fact, the medical device industry is presently overwhelmed with the need to develop and supply various types of products to cater to the ongoing COVID-19 testing initiatives, across the world. As more cases of the disease are identified, restrictions imposed on both national and international movement of goods are anticipated to impact the import / export of medical devices, as well. In order to address this problem, it is very important for MedTech manufacturers to be flexible in their operations, leveraging all applicable exemptions, and optimizing internal processes by fulfilling emerging needs through innovation. Further, in general, any strategy conceived / deployed in this crisis must be communicated in an effective manner, across both public and private stakeholders in the industry.[3]

Over 300 CROs presently offer a wide range of preclinical and clinical research-related services to medical device developers

It worth noting that more than 85% CROs offer clinical development services to sponsor companies. Further, the market is currently dominated by the presence of very small and small companies (less than 51 employees), that represent over 50% of the total players. In fact, in the past few years, the domain has witnessed the establishment of several start-ups.

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

More than 70% of medical device CROs are based in North America and Europe. Within North America, majority of the service providers are headquartered in the US, in fact, over 50% of preclinical service providers are US-based; whereas, in Europe, most of the CROs are distributed across France, Germany, Switzerland, Spain, Italy and Sweden. Further, a significant number of such players (30%) are headquartered in Asia-Pacific and other developing countries of the world.

Deal Making in Medical Device CRO Domain

The medical device CRO domain is witnessing significant consolidation activity since the past few years. This can be attributed to the rise in competition within this domain, which has further compelled medical device service providers to diversify their portfolios through mergers and acquisitions. More than 35 instances of mergers and acquisitions have been reported in this domain, during the period 2015 and 2020 (till mid-March).

Majority of the deals in this domain were acquisitions (92%). It is worth noting that, of the total number of acquirers, 58% were privately held firms, while the rest were public companies. However, majority (94%) of the acquired companies were private companies.

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

Medical Device CROs Market to Grow at a Healthy Rate in the Foreseen Future

Over the years, outsourcing has become an indispensable business strategy within the global medical devices market. Moreover, the increasing regulatory stringency worldwide, is causing many innovator companies to rely on the expertise of CROs to liaise regulators and handle the intricacies associated with product approval. According to our estimates, the overall medical device CRO market is anticipated to grow at an annualized rate of 6.4%. The demand for such contract services is likely to be driven by clinical stage operations (78%), with the maximum share of revenues expected to come in from clinical trial management services (68%), both in the short- and mid-long term. This is anticipated to be followed by data management services, which are expected to contribute to 16% of the total share by 2030. Other important service segments include regulatory services (5.9%) and consultancy services (4.4%).

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

The share of preclinical service providers is estimated to be over 20% of the overall market, with the largest share of revenues expected to come in from sterility and microbiology testing services (35%). This is likely to be followed by biocompatibility testing services (31%), and material characterization and analytical services (20%).

MEDICAL DEVICE CROS – THE NEXT GROWTH OPPORTUNITY

In the long term, service revenues for medical devices intended for the treatment of CNS disorders (14%) are expected to make up a relatively higher share of the market. This is attributed to the anticipated growth in number of clinical trials of devices targeting Parkinson’s disease, Schizophrenia and strokes. It is likely to be followed by revenues from services offered for devices intended for catering to cardiovascular disorders (12%), oncological disorders (11%) and bone disorders (6%).

In terms of service revenues generated across difference device classes, class III devices are presently estimated to be responsible for the largest share (48%) in the overall medical device CRO market, followed by class II (45%) and class I (7%) devices. As of 2020, the contribution of service providers in North America is likely to be the largest (41%) in the overall medical device CROs market. This is likely to be followed by stakeholders in Europe and the Asia-Pacific, representing 32% and 25% shares, respectively.

Visit this link for more Insights.

Medical Device CROs Market (2nd Edition), 2020 – 2030

You may also be interested in the following titles:

  1. China Biopharmaceutical Contract Manufacturing Market, 2020 – 2030
  2. Continuous Manufacturing Market (Small Molecules and Biologics), 2020 – 2030
  3. Prefilled Syringe Fill / Finish Services Market, 2020-2030

The post Medical Device CROs – The next Growth Opportunity appeared first on Blog.