Compliance & Regulation

Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges

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In this blog, author Vincent Balgos discusses the 2024 MedTech Conference, which took place in Toronto, CAN, from October 15 – 17, 2024.

Shaping the Future of MedTech: Insights from Industry Leaders on AI, Innovation, and Regulatory Challenges

Jama Software made its debut appearance at 2024 MedTech Conference in Toronto, CAN recently, and it was an inspiring experience. In addition to meeting passionate medical technology developers, learning the latest innovation trends, and establishing networking connections, I had the opportunity to attend a few panels/talks that wanted to share some insights.

Keynote: Medtech in Motion: Shaping the Future of Health Care Innovation

Attendees (left to right) Peter Arduini – President & CEO at GE Healthcare; Mike Mahoney – Chairman & CEO at Boston Scientific; Roy Jakobs – CEO at Philips; and Joanne Wuensch – Moderator.

With the keynote introduction and brief overview of med tech evolution provided by by AdvaMed’s President, the main event was a panel of Chief Executive Officers from GE Healthcare, Boston Scientific, and Philips discussed key factors that are forging the path of industry innovation.

Artificial Intelligence’s (AI) continual emergence in the conversation of innovation with application for both internal and external purposes. On the external side, AI’s predictive approach is a dominant talking point, supporting medical professionals on complex data analytics by identifying trends, correlations, etc., to help inform clinical decisions at scale. On the internal application, generative AI technology was mentioned as a potential factor to streamline efficiencies with improved internal processes and workflows within the organization. This is a topic that both AdvaMed President and GE Healthcare CEO have previously posted about, highlighting AI’s benefit on both the external and internal fronts that is already reaching patients’ bedsides and company’s processes (respectively) now. These tech-enabled efficiencies are proving to be a potential game changer in the way medical devices operate and develop products. An interesting un-answered question is the integration of AI into an ecosystem of tools, processes, and products, and its impact on the overall value.

The CEO panel unanimously agreed that removing bottlenecks, reducing inefficiencies, and leveraging automation are key for continual innovation in the med industry. With resources becoming limited and the complexity of technology increasing, there’s a continual search for innovative ways to develop safe and effective products faster. To paraphrase, any efforts to allow the development team to focus more on development activities and automate the routine, mundane tasks such as documentation provide teams more time to do the more challenging tasks.

Looking forward five years from now, the discussion turned to how to balance the fast innovation trend seen in emerging/non-traditional markets and the safety and effectiveness performance expectations of the medical industry.

  • Is there a way to harmonize both to develop safe products, but at accelerated velocity?
  • Also, how will regulations keep up with the pace of innovation, especially AI?

While FDA proactiveness is helping guide the industry, there are still a lot of unknowns that need to be discovered, derisked, and regulated appropriately.

On the second bullet, Jama Software can support the acceleration of development processes by streamlining the requirements, verification/validation, and risk management all within a single tool. By leveraging the out-of-the-box solutions, traceability to quality best practices becomes an automated byproduct, where can easily create technical documentation at the push of a button. By making routine documentation activities routine, developers can then focus on the more challenging aspects of product development, thereby increasing the velocity and efficiency of innovation. To learn more, please contact us.

 

Attendees (from left to right) Janet Trunzo – Moderator; Dr. Michelle Tarver – FDA Office of the Center Acting Director; Dr. Jeffrey Shuren – FDA Office of the Center Director; Dr Daniel Canos – Director, Office of Clinical Evidence and Analysis; Dr Owen Faris – Director, Office of Product Evaluation and Quality; and Troy Tazbaz. – Director, Digital Health Center.

Pictured (from left to right) Dr. Michelle Tarver – FDA Office of the Center Acting Director; Dr. Jeffrey Shuren – FDA Office of the Center Director.

What better way to start the last conference day than having breakfast while listening to the FDA Center of Radiological Health (CDRH) panel sharing some of their leading thoughts on trending topics within the industry. With introductions by Terumo CEO and announcing the upcoming retirement of Dr. Jeff Shuren (Director). Next was the introduction of Dr. Michelle Tarver as the incoming Director, where Dr. Tarver gave an introductory speech, highlighting her focus on a patient-first approach, providing access and equity to safe and effective medical devices to general population, and her visions for continuing and evolving FDA’s path for regulatory guidance for industry, including the Home as a Health Care Hub initiative.

RELATED: Jama Connect® for Medical Device & Life Sciences Development Datasheet

After the panel introduction, the audience was encouraged to ask questions. Some (paraphrased) questions and responses are below:

[Editor’s Note: These responses are paraphrased from the FDA and not actual FDA statements. Please also note that Jama Software is not a regulatory consultant. These are observations only.]

How is FDA providing medical care access to more underserved patient population, particularly the women population?

Response: One of the key strategic priorities for CDRH in 2022-2025 is advancing heath equity for all patients and evaluations that take into account is the diverse population for which they are intended.

Jama Software: After the conference, an online search resulted in an Executive Summary for more information. Referencing the introductory speech, Home as a Health Care Hub seems to be a key factor in broadening all patients’ access to healthcare.

How does industry streamline their submissions processes and success rate to the FDA? It is very costly to the organization for each resubmit & re-address cycle.

Response: Before formal submission, it is highly recommended to consider pre-submissions as part of the regulatory strategy. This allows early interactions between FDA and the organization to help answer questions, identify gaps in the submission, and provide general guidance for a successful pathway.

Jama Software: Based on my experience, pre-submissions are standard of practice to help derisk many unknowns and help successfully navigate through the complicated submission process, especially with novel technologies or indications of use scenarios. I’d consider FDA as more of a partner than “overlord” as they have the shared goal of providing safe and effective medical to US patient population. If done correctly, pre-submissions save organizations time and money, since many of the questions / issues are proactively addressed.

While the FDA has been proactive in providing regulatory guidance on Artificial Intelligence development and applications, there are still many open questions, especially in generative AI and post market scenarios. What are some key areas that are in discussion (e.g., validation of generative AI)?

Response: Generally acknowledged that there is a lot to still discuss since it is an evolving technology. The 2023 draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan fo Artificial Intelligence/Machine Learning (AI/ML) – Enabled Device Software Functions” provides some considerations in how to manage change, especially in the post-launch scenarios. Since GenAI is continually learning and adapting to new data, there will be focus on post-market topics and how to handle AI’s dynamic state. This includes validation strategy and some general guidance. In addition, some general questions for organization to consider during AI development are:

  • What are the general problem statements that AI is trying to solve?
  • What are the large language models (LLM) being used for the device? Does the LLM support the devices intended use case(s)? Or is it the rationalization part of AI that is assessing data?
  • Would a separate AI be needed to monitor / manage the device’s AI?

Defining these approaches may help understand the associated benefits and risks with these new devices.

Jama Software: Previous FDA documents (1, 2) also shed some light on what the regulatory framework could look like in the future, so encourage research and comprehensive documentation of AI’s software requirements, testing, and associated risks.

Overall, breakfast with FDA was an insightful experience to understand what the regulatory body is thinking around current topics. When it comes to complex medical device development, Jama Software can support regulatory and quality compliances to key standards (Design Controls, ISO 13485) to allow teams to streamline their work efficiencies, reduce rework, and accelerate product launches to market.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Below are a few additional thoughts and insights gleaned from the speakers at the MedTech conference:

Medical Cybersecurity Digital Health Technologies

Panelists:

Tech-Enabled Efficiency

To go faster, what tools and processes can be used to automate the more mundane tasks?

Digital Health Coverage is Limited

The regulators and industry are still trying to catch up. This is why hospitals are getting attacked, breeches, etc. Software is becoming more and more prominent, plus the software with connections introduces a huge vulnerability for bad actors. We’re still trying to wrap our heads around this. Final guidance on cybersecurity was released in 2023. There must be a cybersecurity plan included in your final submission.

Faster is Not Always Better

Unlike consumer electronics or social media, medical device & life sciences industry likes innovation, but having the latest innovation is not always great – the tradeoff is reliability, safety, and effectiveness. Just because you CAN go faster with innovation and development time, doesn’t mean you should. Because we deal with patients, we have to keep quality in check. We need to take a more thoughtful, steady, and proactive approach. If we don’t understand the software, we are putting a lot of our patients at risk.

Longitudinal Thinking and Applications

The CEO of GE and Philipps mentioned this twice in their speech. In this area, they want to have longitudinal traceability OUTSIDE of the device – worrying about the infrastructure, the users, the medical records, and other aspects of the product or the organizations. The impact isn’t on my device, there’s a broad impact.

In your submissions, in terms of cybersecurity, you must have good documentation. Define your problem, what are your indications of use, what is your environment of use (is this a connected device, where are the digital connections and vulnerabilities). What the FDA is looking for is a story to take a more risk-based approach to developing and approving products.

In medical device development, we used to have this thought: If you’re not sure of something, go back to the documentation. Trust it but verify it.

The new thinking is that you should never trust it and always verify. Documentation is becoming more complex, and teams sometimes aren’t documenting in the way that they should.

Vincent Balgos
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