How to Survive FDA’s Predetermined Change Control Plan
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This article originally appeared in MD+DI on September 10, 2024.
It’s rare to hear the private sector applauding a regulatory agency, but the FDA’s Predetermined Change Control Plan (PCCP) deserves recognition. This initiative could be one of the most transformative in the agency’s history, driving innovation in medical devices while enhancing patient safety through continuous improvement.
However, a shakeout is on the horizon that will expose those companies with IT environments that were originally built on 1990s infrastructure. These IT systems never envisioned the cloud or AI, today’s volume of users, or the demands of modern applications. Over the coming years, it will become clear which manufacturers have successfully transformed their aging infrastructures with the right FDA compliance software to fully leverage the benefits of the PCCP. The difference will be immediately obvious when you compare the number of annual releases or versions on the app store. Companies that adapt will release updates frequently and incorporate AI/ML. However, most companies will struggle to make this transition, and, as a result, won’t be able to harness the PCCP. These companies will find themselves left behind by more agile manufacturers.
Erez is passionate about improving patient care and health outcomes with software solutions. Over the last decade, Erez worked in industries including computational mathematics, biotech, and energy, helping build monitoring systems for pharmaceutical equipment and AI for medication management. Before Ketryx, Erez worked with Amgen, the world’s largest biotechnology company, as the head of AI/ML for their medical device division and with Wolfram Research, the builders of Mathematica and Wolfram|Alpha. Erez holds a Master of Science in Electrical Engineering and Computer Science and a Master of Business Administration from the Massachusetts Institute of Technology.
