Making Software Safe and Reliable
The Process is Broken
The process for complying with FDA regulations is broken. Today, MedTech teams spend the bulk of their time on meeting regulatory requirements rather than driving product impact. We knew there was a better way to move at the expected speed of software development while making safe and reliable software patients can trust.
Stakeholders Aren’t Aligned
As Head of AI and Machine Learning at Amgen, Erez Kaminski found the regulated development process frustrating, with key stakeholders often at odds because of varying priorities:
- Quality required a risk-based approach to ensure traceability while developers rejected the antiquated tools and manual sign-offs that dictated a typical compliance process.
- Quality fumed that Developers weren’t concerned enough about safety
- Developers viewed Quality as blockers to efficiently bringing software to market.
Industry stats uphold this bleak picture – more than 50% of regulated developers leave within the first 6 months because of dissatisfaction. In turn, approximately 70% of all MedTech products are delayed, and software issues are the biggest contributor to defects and recalls (McKinsey).
Belief in a Better Way
Convinced there was a better way, Erez founded Ketryx in 2021, assembling a team of world-class developers, quality and regulatory professionals as well as experts in AI and Cloud. Former FDA guru, Paul Jones, who wrote much of the central medical device standard ISO 62304, was so convinced Ketryx could make a significant impact on healthcare, he became an early recruit to the executive team.
Today, Ketryx is working with some of the largest MedTech companies in the industry with headquarters in the Boston area and offices in the U.S. and Europe.
Meet Our Team
Erez Kaminski
Erez worked at Amgen, the world’s largest biotechnology company, as the head of AI/ML for their medical device division. Prior to Amgen he served as the special assistant to the CEO of Wolfram Research and as a visiting researcher at Princeton Plasma Physics Labs. Erez holds a Master of Science in Electrical Engineering and Computer Science and a Master of Business Administration from the Massachusetts Institute of Technology and served as a platoon sergeant in the Israel Defense Forces.
Jan Pöschko
Jan led cloud development for Wolfram Research, where he and Erez worked together to launch developer tools used by millions of users each day (Wolfram|Alpha, Mathematica). He has over 15 years of experience as a software developer and infrastructure architect and for the last decade has been leading the development of the Wolfram Cloud, a developer-first infrastructure cloud technology stack. Prior to Wolfram, Jan was a visiting researcher at the Stanford Biomedical Informatics lab. He holds a Master of Science degree in Mathematical Computer Science from Graz University of Technology.
John Koontz
John has held roles in research, engineering, IT, and operations in the software industry for over 25 years. Most recently, he was both the VP of Engineering and Chief Information Officer for operations and compliance at Wolfram Research, primarily focused on Wolfram Alpha, the world's most used and knowledgeable AI project. He directed global platform operations and R&D efforts, as well as 3rd party integration with customers like Apple, Amazon, and CVS-Health. His computer science and engineering experiences include large scale parallelized simulation models, design of high performance computing systems, directing IT architecture at a state university, and working for quality-focused research organizations such as Argonne National Lab and NASA. He holds a Master of Science degree in Computer Technology from Eastern Illinois University.
Paul Jones
Paul is a world-renowned software safety expert who joined Ketryx following close to 25 years at the Food and Drug Administration (FDA). He helped create the FDA’s approach to safety-critical software and medical devices and founded the FDA’s software engineering lab. While holding committee positions with groups that handled medical software safety standards like ISO 13485, ISO/IEC 62304, and ISO 14971, he reviewed over 300 devices, carried out numerous inspections, and provided training to FDA staff on software quality, risk management, and software engineering. Prior to the FDA, he worked 20 years as a systems/software engineer for companies like Ford Motor, Electronic Data Systems, Honeywell, and SAIC. He holds a Master of Science degree in Computer Engineering from Loyola University, Maryland.