Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

The emergence of COVID-19 created a series of challenges and obstacles for nearly every industry. The medical device industry, in particular, was put to the test to accelerate production and delivery of devices that could restore and ensure health and safety to the global population: reinforcing our mission and foundational goal as medical device professionals to improve and save lives.
 
As the year draws to an end while the pandemic rages on, medical device companies continue to find themselves facing unforeseen challenges, whether that be centralized teams adjusting to the pivot in new remote work operations, managing delays with clinical trials, or supply chain issues threatening the ability to meet demand.
 
2020 threw us a curveball, inciting a fight-or-flight response with little to no preparation time. Success in this unprecedented year was determined by whether companies used this multipronged approach: Leverage best-in-class tools that enable the agility, innovation, and peak performance that was needed to quickly visualize, adapt, produce, and deliver the outcomes needed. That is the winning formula for how medical device companies stayed ahead of the curve in 2020.
 
As we head into 2021, we must learn and understand which industry trends are on the horizon in order for us to adequately prioritize initiatives that will pave the road to success. The 2021 State of Medical Device Virtual Summit, hosted by Greenlight Guru, is an free online event taking place on December 8-9, 2020 that will bring the medical device community together to understand the strategies, tactics and technologies being used today and uncover best practices, tips, and trends for the evolving nature of the industry to help your company move forward and succeed in 2021.
 
To help you gear up for this highly anticipated event and identify the best areas of opportunity for your company, I’ve tapped into our network of leading device experts, who will also be presenting at the 2021 State of Medical Device Virtual Summit, to share their best insights and tips on how you can achieve success in 2021 and beyond.
 
Rise of Telehealth
In response to the pandemic, the United States had to scale its telehealth platforms to meet the rising demands for remote patient care. In fact, a McKinsey report revealed that the number of patients who used telehealth increased from 11% in 2019 to 76% in 2020.
 
Pooja Kartik, senior director of quality & regulatory at Triple Ring Technologies, weighed in on the growing telehealth demands. “With COVID-19 in our life disrupting the normal and setting a new normal, I expect bigger shifts to occur in the next couple of years, especially around digital health, patient data management, remote healthcare services, prescriptions, and digitizing many patient/data transactions, including visits.”
 
According to Chris DuPont, CEO of Galen Data, the medical device landscape is going to push for connectivity among various components, including telehealth. DuPont shared that “the traditional stand-alone medical device is transforming into the concept of a ‘medical device ecosystem.’ The ecosystem incorporates the conventional physical device—the ‘appliance’ that is implanted or worn by the patient—and also includes supporting components including a mobile app and cloud connectivity. It will become increasingly important in 2021 that these components—appliance, app, cloud—work in concert to the patient’s ease-of-use and health benefit.”
 
Outside of digital healthcare and medical devices, Gary Saner, senior manager of information solutions-life sciences at Reed Tech, predicts an increased push for standardized digital technologies in all areas, from marketing applications, product registrations and listings, to postmarket surveillance. Saner believes that “medical device manufacturers will see a continual migration toward more product information being required to be reported in electronic, structured format and the use of more data standards.”
 
While the rise and heightened focus on telehealth practices were hastened by new restriction measures to mitigate viral spread, this group of medtech experts believes similar developments in digital healthcare technologies will continue to revolutionize how patients receive care.
 
Increased Cybersecurity Efforts
The increase in telehealth services has led to an expansion of users’ digital footprints, creating new vulnerabilities to cybersecurity threats on breaching patient, provider, and device manufacturer data.
 
Christopher Gates, principal system security architect at Velentium, describes the relationship between telehealth and cybersecurity. “The demand and use of telemedicine and no-contact medical devices will continue to surge, and much of those gains will be permanent,” he said. “Both trends increase the attack surface of medical devices, and because of our current situation, these devices are being rushed to the market with a higher potential for inadequate or non-existent security mitigations, which is unsustainable except as a temporary emergency measure.”
 
To ensure patient safety is at the forefront of our efforts, FDA published helpful materials and guidelines outlining cybersecurity vulnerabilities for medical device manufacturers and how to mitigate the risk of infiltration. Gates echoes the agency’s prioritization and sentiments regarding cybersecurity threat mitigation. “The FDA has ramped up their cybersecurity oversight efforts. Where previously we would see one to six questions asked as part of the premarket submission process, we are now seeing dozens of cybersecurity questions being asked,” he said.
 
Gates encourages device makers “to get ahead of the process, start your cybersecurity efforts on the first day of development. There are three places in the development lifecycle where vulnerabilities are introduced: design phase, implementation phase, and the use of third party software components (AKA TPSC, or SOUP). Do your due diligence, perform your testing, create SBOMs, and scan for disclosed vulnerabilities on any of the third-party software components.”
 
Trending telehealth technologies and associated cybersecurity threats will become more prominent in 2021. So how can medical device professionals embrace change, mitigate threats, and continue working toward our shared mission to improve and save lives in the unique 2021 landscape?
 
Stay Updated on Changing Medical Device Regulations
We’re beginning to see several regulatory changes take shape throughout the global medical device industry. To ensure your organization, product, and processes are kept up-to-date and in working order, having a medical device quality management system (MDQMS) that can support and simplify those efforts has never been more important.
 
With the transition date to EU MDR right around the corner, along with other regulatory updates and changes to follow, managing a quality system that is unable to demonstrate closed-loop traceability will present significant challenges to companies.
 
With regard to new regulatory requirements that will soon go into effect, Saner shared the following advice: “In 2021, many regulatory authorities are layering on new unique device identification (UDI) product requirements. To be successful in 2021, medical device manufacturers need to research the regulations, plan their approach, and execute a comprehensive UDI implementation in their efforts to meet the new UDI challenges.”
 
Kartik takes a similar stance in the advice she offers, stating that remaining updated on regulatory changes is the best way to navigate 2021 successfully. “My advice is to stay vigilant and flexible with the regulatory changes, and life changes that are happening around us to help bring the medical devices and technology that people need,” she said.
 
Conclusion
It’s essential to note our mission of providing safe, reliable, and high-quality medical devices does not change; ultimately, our ability to deliver on that goal is the true marker for success. The COVID-19 impact on the medical device industry, while important to analyze and learn from, should not put your company initiatives on the back-burner.
 
Patients need your products and technologies to improve their quality of life. We must each do our part to fulfill this key mission and succeed in the unique and evolving medical device landscape, now and in the future.
 

---

Nick Tippmann is the vice president of marketing for Greenlight Guru, a medical device quality management software (MDQMS) that provides an industry-specific solution to help device makers around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later acquired.