Last week’s FDA decision and announcement to create a new, streamlined regulatory model for software related technologies, promises to disrupt disease diagnosis and treatment and is exciting as it creates tremendous opportunities for patients and the industry.
The pre-cert for the 9 companies included in the model (see below) is akin to a TSA pre-check at the airport for pre-qualified customers. It will create a digital trial master file framework/model that lays out the processes, standards, quality, system validation, audit trails etc. in advance, such that when these new healthcare product players bring a new software product to market for diagnosis or treatment, a regulatory path has been prepared in advance to streamline approval. About time! Software is a key part of the overall digitization of the health world, and the model will accelerate innovation, help to spur new service delivery models, generally help with outcomes such as improved patient care and ultimately help to save lives or prevent health issues in the first place.
The pilot participants represent a wide range of companies and technology in the digital health sector, including some of the biggest brands in the world as well as exciting new startups, who develop and deliver high and low-risk medical device software products, medical product manufacturers and software developers. The pilot participants that were selected are listed below:
- Apple: Cupertino, California
- Fitbit: San Francisco, California
- Johnson & Johnson: New Brunswick, New Jersey
- Pear Therapeutics: Boston, Massachusetts
- Phosphorus: New York, New York
- Roche: Basel, Switzerland
- Samsung: Seoul, South Korea
- Tidepool: Palo Alto, California
- Verily: Mountain View, California
The FDA received interest in the program from more than 100 companies. In selecting the participants, the agency considered several factors including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product. The FDA’s selection process identified companies that represent different perspectives and unique approaches to digital health technology development.
There’s a lot more to it than that, but that’s the 30k foot explanation so if you would like any assistance in navigating this new model, and what it means to your business, our Radius Innovation & Development group, a Jabil company, will leverage our 2 decades+ of deep life sciences, healthcare expertise, human factors expertise, UI/UX design, and software design & development capabilities to partner with you (who are or are not part of the FDA “pre-cert”/pre-check pilot) to ensure your designs and development plans meet patients’ needs and are compliant with the new FDA guidelines.
You may have all the software chops in the world needed to design world-class digital solutions, however, if you need assistance on the Healthcare side, that’s where Radius shines. So don’t hesitate to contact us, this is groundbreaking news and will help you get your innovation to market faster.
Please feel free to contact Mike Susi for more assistance, visit us at radiusinnovation.com, or take a look at our video to help you understand how we help our customers realize their innovation and ultimately achieve outcomes that matter!
Finally, if you are interested an exciting role in the innovation and development world, whether you have research/strategy, design, or an engineering background, check out our careers page to see if there is a role for you!