By Stephen Booze
In the race to bring quality devices to market, medical device manufacturers have the dual challenge of keeping pace with innovation and shifting regulatory compliance rules. The recent MD&M West conference in Anaheim was a much-needed pit stop in the cross-country road rally that is successful medical device regulatory approval.
MD&M West brings together a pit crew of the finest minds and most forward-thinking companies on bringing a medical device to market. They are collectively instrumental in helping manufacturers adjust and finetune their MDM engine approach to plot regulatory and technology course changes.
Presentations around a major regulatory course change focused on the latest medical device class exemptions and other definition changes as a result of the 21st Century Cures Act. That was the informative focus of presenters like leading FDA regulatory consulting firm Greenleaf Healthcare and pharmaceutical giant Merck.
Diagnosing FDA’s Approach to Speed, Quality, and Innovation
The MD&M West presentation by Daniel Schultz, MD showed how manufacturers could fine tune their steering as well as R&D fuel mixture to move them faster and safer to the regulatory finish line as a Principal leading Medical Devices & Combination Products for Greenleaf Associates, the one-time Director of CDRH at the FDA looked at the FDA’s emphasis on speed quality and innovation.
Greenleaf provided insights into how ‘engine’ modifications to existing devices would impact regulatory journey endurance via the proposed 510K updates and the Safer Technologies Program (STeP). This diagnostic look at premarket notification was balanced by overviews of needed medical device cybersecurity and helpful process changes at CDRH.
Dr. Schultz also discussed the importance of the intersection of Investigational Device Exemptions (IDEs) and early feasibility medical device clinical studies. This was explored through the lens of the importance of applying the science of patient input processes to garner valid scientific evidence. Patient science and engagement provided greater contextual understanding for evidence gathering in R&D stages and how that can impact FDA regulatory processes and consultations.
Digital Health Solutions and Risk Management in the Regulated Space
The Merck presentation by Merck Director of Regulatory Affairs Suraj Ramachandran was a sweeping look at digital health solutions and risk management in the regulated space. One key inspection point was providing a greater understanding of how section 3060 of the Cures Act and its medical software policy changes will impact MDMs and software development.
Merck’s presenter showed how the company’s approach to MDM life cycle speed and quality could be enhanced by a self-diagnosis of its own engine of continuous improvement. This look under the Merck hood used their Patient Technology Initiative to show how they and other MDMs can accelerate the development process and improve outcomes over the device life cycle through:
- Data sharing
- Creating tools and applications for data collection and streamlined reporting
- Engaging stakeholders for broader input and developing regulatory understanding between HAs and industry stakeholders on the use of patient technology
The Merck presentation provided a great deal of practical procedural knowledge of how the regulatory road ahead is laid out and how to successfully navigate it.
Everything R&D Teams Need to Know About Deep Learning
Navigation and plotting MDM technology course corrections were primary roadmap themes as presenter Jesse Livezey, provided insights on where we are with AI and deep learning (DL) associations with medical devices. By explaining the basic needs and processes of DL and DL libraries, Livezey showed how AI could impact healthcare rehabilitation outcomes.
Controlling prosthetic devices and speech recognition support for brain patients were just two examples used by the Lawrence Berkeley National Laboratory (LBNL) Postdoctoral Researcher. While this AI roadmap is still in early development stages, Livezey showed attendees how deep networks could impact outcomes connected to limb and speech rehabilitation.
The Importance of the MD&M Regulatory Journey Pit Stop
The importance of this conference to everyone in the MDM value chain can’t be overstated as regulatory twist and turns come as fast as the device technology innovations on the road to a successful medical device. The MD lifecycle from R&D to testing, regulatory approval, and successful launch is tightly bound with successful device marketing and ongoing product support and customer satisfaction.
Since no one has a complete map to the journey, events like this year’s as well as 2020 MD&M West are key pit stops that keep MDMs moving in the right direction of device quality speed and efficacy. A recurring theme echoed by presenters and a vital takeaway was to “Stay informed with regards to changes in the “regulatory landscape” just as you do with changes to the “technical landscape.”
About the Author:
Stephen Booze is the VP of Digital Innovation for Solugenix where he supports the company’s mission of providing services, talent, expertise, and technology platforms, such as ServiceNow, that Increase operational efficiency, performance, customer service and sales fulfillment.