Tag Archive for: Wearable

In this blog, we discuss key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on digital health technology.

What is Digital Health?

Digital health merges digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery to make medicine more personalized and precise.

Digital health is a broad category that includes:

  • Mobile health (mHealth)
  • Health information technology (IT)
  • Wearable devices
  • Telehealth
  • Telemedicine
  • Personalized medicine

Digital health technologies use:

  • Computing platforms
  • Connectivity
  • Software
  • Sensors

RELATED POST: Ensuring FDA Compliance for Your Digital Health Solution

The Rise of Digital Health 

The past decade has ushered in major disruption in all industries, including the medical device and life science sectors. Market disruptors such as smartphones, social media and more transformed the way that people work, play, and manage their health. Software has transformed how doctors practice medicine, how people manage their health, and the fundamental interactions between patients and providers. During this process, the boundaries between digital health and medical devices began to blur.  

According to the Food and Drug Administration (FDA), “Digital health technologies use computing platforms, connectivity, software, and sensors for healthcare and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device.” These applications are driving a lot of the wearables we see today, like a heart rate monitor running on a smart watch or a mobile application connected to a wearable. Other examples of digital health applications might be something like 23andMe, which uses genetic sequencing data to identify health risk factors.  

The Emergence of Software as a Medical Device (SaMD) 

Traditionally medical devices have been classified as an instrument, sometimes with software running on the actual device itself. 

The lines between digital health technology and medical devices get crossed once the software technology begins to perform a medical function, especially if the technology is not embedded within the medical device. Consider software that determines the right medicine dose for a patient based on his or her personal data, or software that detects and diagnoses a stroke through analyzing MRI images. These are examples of software that could be serving as a medical device. 

As digital health has pushed further and further into the traditional realm of medical devices, an entirely new category was formed and regulated, which is software as a medical device (known as “SaMD”). SaMD is described as “software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case), it’s the software itself that performs the medical function.” 

With the emergence of software as a medical device, there are questions around risks, regulations and safety. Understanding trends and potential risks can help teams mitigate challenges and navigate forward with greater success. 

To learn more about keys to success and best practices in the digital health medical device market, download the full whitepaper

Despite ongoing concerns about cybersecurity, the medical device landscape has seen some amazing advances even just this year.

Putting the End User in Control

End users, consumers, and patients are finding themselves with more knowledge about — and control over — their health than ever before. And that’s thanks, in part, to recent advancements in medical tech and, wearables, in particular.

In 2018, Apple introduced the first direct-to-consumer EKG wearable “cleared” by the FDA when it rolled out the EKG and irregular heartbeat features on its Series 4 Apple Watch. The watch has been classified as a Class II medical device, and a recent Standford University study revealed it can help detect atrial fibrillation — a type of irregular heart rhythm, which is the leading cause of stroke and hospitalization in the U.S.

Combined with other medical tech advancements like Bluetooth-enabled “smart” inhalers for asthma and COPD sufferers and wearable blood pressure monitors, the medical device industry continues to trend toward giving patients better control and management over their own health. Between 2014 and 2018, consumer use of wearables jumped from 9% to 33%. There are currently almost 200 clinical trials involving medical tech wearables in progress.

The impact of such fast-moving technology is still being measured, and, among other things, it’s making some question if wearables might actually decentralize medical care by making frequent visits to the doctor’s office less necessary.

Read our eBook to learn more about risk management for Class II and Class III medical device development.

In the Field

Medical tech and medical devices continue to improve patient care in clinical settings as well.

Artificial intelligence company care.ai is working with Google to develop a “Self-Aware Room” for hospitals. This technology would monitor patient conditions and send notifications to staff to keep them apprised of patient conditions. The technology could help clinicians better manage patient safety and health by predicting things such as preventable falls, pressure ulcers, and infectious diseases that would compromise patient health.

The partnership is part of an overall trend toward edge computing in hospital settings. Though edge computing doesn’t solve all cybersecurity challenges by any means, the trend does bring computing closer to the data source — in this case, the patient — which can help to mitigate some cybersecurity challenges.

AI and augmented reality technologies are also changing operating rooms. One recent report suggests that as many as 45% of operating rooms will be integrated within the next four years. The intelligent technologies will result in less invasive surgeries and improved patient outcomes.

Microsoft and Phillips have also partnered to develop augmented reality technology for surgery. The technology would transfer live imaging and other sources of information into a 3D holographic environment that the surgeon could control.

Alex Kipman, technical fellow, AI and mixed reality at Microsoft, notes that “[m]ixed reality holds great potential in healthcare, and our collaboration with Philips shows how that potential is already beginning to be realized.”

Learn more about how Jama Connect™ helps medical device developers streamline and speed up the development process while reducing risk.

Cybersecurity Concerns

Of continuing concern for medical device manufacturers and their partners are cybersecurity threats.

The FDA recently issued a safety communication concerning the URGENT/11 security threats. These vulnerabilities were first identified in July, and they affect several operating systems used in medical tech and industrial devices.

Suzanne Schwartz, M.D., MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, noted that the FDA was not aware of any patient harm resulting from the URGENT/11 vulnerabilities. However, she noted that “the risk of patient harm if such a vulnerability were left unaddressed could be significant.”

The communication highlights the ongoing challenges of not only addressing current vulnerabilities and cybersecurity threats, but also integrating protections into medical devices currently under development. Staying one step ahead of remote attackers is always a challenge for developers in any industry, but in the medical tech realm, patient health is a very present concern. Security vulnerabilities can put patient health and safety at risk.

The FDA also recently introduced a new, voluntary program for medical device and device-led combination products. Called the Safer Technologies Program for Medical Devices, the program is designed to help expedite development, assessment, and review of certain medical devices that are not eligible for the Breakthrough Devices Program. Draft guidance for the Safer Technologies Program is available online; the commenting period ends November 18, 2019.

Learn more about recent pending updates to the FDA’s cybersecurity for premarket submissions in this blog post.

Potential for Collaboration

Though the market entry of such tech giants as Amazon and Apple can pose challenges for legacy medical device manufacturers, the Microsoft/Phillips and care.ai/Google collaborations suggest a development that could benefit all parties.

While tech giants don’t have a long history of navigating the FDA approval process, they have been grappling with cybersecurity issues for some time. Medical device manufacturers and tech giants would be wise to combine their strengths and expertise to continue to combat cybersecurity threats while bringing new medical devices to market and improving patient care.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.