Medical Device Prototypes
Could FDA regulations impact university-developed prototypes?
Sponsored Research Collaborations
The FDA requires, under its Quality System Regulations (QSR), that a company documents in a particular fashion the history of its development of medical products. These regulations, also referred to as “design controls”, require that such documentation includes the original customer needs-based rationale for product design and performance goals, as well as a record of all authorized (management-approved) changes made during the entire development program.
It may be surprising to learn that a university-developed prototype device could potentially require “design control” documentation…
Some level of Design Control documentation may be deemed necessary if the prototype is destined to be tested on humans, or even if the prototype would ever be used to collect bench or animal data that would subsequently be included in a regulatory submission to demonstrate safety and/or efficacy of the device.
FDA Rationale: If a regulatory reviewer is not confident an earlier generation, university-developed prototype device (that was used to generate submitted data) is equivalent to the device for which approval is subsequently being sought by the corporate sponsor, the submission may be rejected.
Therefore, in the event that prototype development work is being conducted within a university under a company-sponsored research agreement, it would be advisable for the university principal investigator to seek guidance from the company early in such a relationship regarding company strategy for data collection and, if relevant, the level of design documentation the corporate sponsor believes would be required in order to “bridge” successfully into a downstream Design History File (DHF).
AGAIN: This issue would not arise unless there was the potential for the university-developed prototype to be used to generate data (including bench or pre-clinical) that might subsequently be presented by the corporate sponsor within a submission to the FDA seeking clearance or approval of a later generation of the device (i.e., following additional outside development by the corporate sponsor).
Within this guide, you can go here for more information on this subject. For a more thorough review of this subject( including helpful examples), visit Stanford University’s Introduction to the Regulation of Medical Devices.
If your project represents a prospective medical device [for definition, see FDA Medical Device Classifications], additional factors come into play when planning demonstrations for either potential licensees or prospective startup investors.
Regardless of the innovation and engineering sophistication that may be employed, the impressive bench data that may have been generated, or the market-ready appearance of the device used in the proof of concept demonstration…
Medical industry representatives and knowledgeable investors will view a university-based prototype as a great starting point – not as a product.
It’s important that you be prepared for, and do not react negatively to, such a view of your prototype development. It’s simply a fact of life in the medical industry that a corporate sponsor (including a university inventor-associated startup company) would have to be prepared to demonstrate in an FDA-auditable Design History File, the user requirements that ostensibly led to the original design specifications for the medical device, along with a documentation system that tracts all management-approved changes along the product design and manufacturing process development path.
It’s practically impossible for these design control requirements to be met without the methodical, virtual re-design of the university prototype. In the course of the re-design, which often involves materials changes, the challenge for the company is to reproduce the functionality that you demonstrated in the prototype. Your assistance as a consultant may be required during this process.
Visit this FDA site, for detailed information on the requirements that are embodied in the Quality Systems Regulations.