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:

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.