The Medical Device Manufacturers Association (MDMA) has been a beacon during the COVID-19 crisis, working closely with the FDA and other key stakeholders to represent the needs of its members and bring innovative devices to patients swiftly but safely.
That’s why it’s no wonder its recent virtual MDMA 2021 FDA drew record-breaking audiences.
The conference featured a number of senior officials from the FDA and the industry who shared key insights and trends that will impact medtech companies’ regulatory and business strategies.
Topics included a look at the FDA’s response during COVID-19, strategies to succeed during the review process and digital health trends.
Mark Leahey, CEO of MDMA, moderated; and speakers included William Maisel, MD, MPH, office director, Office of Product Evaluation and Quality, CDRH chief medical officer, FDA; Joshua Nipper, director, Division of Submission Support Office of Regulatory Programs Office of Product Evaluation and Quality CDRH/FDA; Daniel Schultz, principal, Medical Devices & Combination Products, Greenleaf Health; Darlene Crockett-Billig, president & co-founder, Experien Group; Craig Coombs, president, Coombs Medical Device Consulting; and Bakul Patel, director, Digital Health Center of Excellence, CDRH, FDA; among others.
Following are highlights of three key areas from this informative conference.
The FDA as MVP in COVID-19 response
William Maisel echoed the appreciation the whole industry feels as he recognized the dedication of the FDA staff, who worked around the clock in a concerted effort to quickly and safely get vital devices to market to help fight the pandemic.
Over a year ago the agency started making available the Emergency Use Authorization (EUA) to help with important supplies, such as COVID-19 tests, masks and respirators. They received over 2,100 pre-EUAs and 3,200 EUAs, which resulted in the approval of 600 devices, including over 300 tests. Coupled with non-COVID related submissions, the agency experienced an increase of 68% in total submission volume.
The organization focused on several philosophies of success: prioritizing high-quality submissions that addressed the most acute patient needs; closer interaction with companies submitting devices; and maintaining an agile mindset that would allow them to be strategic as they adapted to the pandemic.
That extended to a desire to move clinical trials forward, reducing the time of approval for investigational device exemption (IDE) by 90% from 10 years ago.
The breakthrough device pathway, designated for products intended for life-threatening or irreversibly debilitating conditions, has been one of the most important developments in the device space to help foster, develop and reward innovative. In addition, CMS continues to examine its implementation of what is known as the “MCIT” pathway, which has the potential to expedite patient and provider access to medical technologies that address unmet needs.
As they begin to vet new filings, William highlighted emerging opportunities within digital health and software as healthcare delivery and care increasingly moves from the clinic to the home.
While the increase in submissions has resulted in a strain, the commitment to safely speeding novel devices to patients has been worth it. The keyword is “agility,” as the agency works to harness innovative approaches that advance the need of patients and work collaboratively with the medical device industry.
Strategies to Succeed During the Review
Those intending to initiate a device review should take advantage of that focus on collaboration. In fact, interacting early with the FDA on submissions is vital, particularly as COVID has taken a toll on the resources of the agency, pointed out Joshua Nipper. That includes everything from trial strategy to classification determination.
Joshua shared several best practices, starting with a solid device description that includes its intended use and consistency in claims, which is important in both the indication and the device design.
Indication of use should include:
- Defining the target population, including data for each subpopulation, which can significantly impact the pre-clinical and clinical testing a company may be expected to provide for its submission.
- Offering the extent of disease state, for example, is it occasional pain or a permanent disability, which will play a role in how a company tests the device.
- Indicating how it’s used, for example, is it a surgical device or a transcatheter?
- Explaining the clinical benefit to the patient, such as whether it is the reduction or elimination of a condition.
Companies should carefully and proactively think through these aspects in order to develop the testing strategy that will support the claims and story they are telling. Choosing these end points appropriately and discussing them ahead of time will typically save a lot of time and hard work since changing the device once the premarket approval (PMA) is almost done will significantly alter the review pathway and dynamics. And of course, reimbursement should be top of mind during the design of preclinical and clinical trials; often companies that receive FDA approval struggle with getting reimbursement later because of a lack of appropriate data.
Finally, expect that the review process may be lengthy and require additional documentation; therefore, be prepared to maintain frequent, responsive and clear communication with the lead reviewer.
Digital Health Update
A third key area of note was in the exciting area of digital, as highlighted by Craig Coombs and Bakul Patel.
Several years ago the FDA introduced the Precertification Excellence program as the foundation of an innovative way for digital health companies to receive FDA authorization for commercialization. Nine companies, including Apple, Verily, Fitbit and Johnson & Johnson are participating in the pilot program, as the FDA learns more about the product development process in order to provide robust, efficient reviews once the program is formally up and running.
This effort to learn and adapt has escalated as hardware and software solutions have emerged exponentially during the pandemic. Until the new effort is operational, companies can continue to submit their digital health devices under the current Multiple Function Devices Products program.
Another important evolution is in the fields of artificial intelligence (AI) and machine learning (ML), as the FDA works to create a collaborative environment and holistic approach that will allow these smart systems to reach their potential.
As Bakul reminded the audience, the FDA remains open to learning from and collaborating with companies, encouraging medtech professionals to contact the Center of Excellence.
That spirit of openness has defined the tumultuous, but successful, year the FDA has had. “While 2020 has been a whirlwind, the industry has made incredible advances with exciting innovations and a common goal of hastening effective and safe devices to patients,” said MDMA’s Mark Leahey.