There’s More to Being a Medical Device Company than IP and R&D
Most emerging medical device companies tend to focus their energy on product development and R&D. This is understandable because medical device founders are often first experienced innovators. As innovators, there’s a natural affinity to maintain a continued focus on product development and maturation. Having a clear IP position and strategy is an important factor for attracting capital, which could further emphasize the importance of R&D, product development and market analysis.
Nevertheless, being, living and growing as a viable medical device company catering to the U.S. market requires much more than R&D, positioning your IP and measuring how big your market is. It involves developing an operational framework that structures your organization as a medical device company (Figure 1) and enables the commercialization of your product.
- Regulatory Affairs
- 21 CFR Part 820
- 21 CFR Part 11, if your device incorporates software
- Quality Management
- Design Controls that are included in Part 820
- QMS requirements you might find in Part 820 and ISO 13485
- Risk Assessment and Risk Management found in FDA Guidances and ISO 14971
- Complying with IEC 60601-1 3rd Edition and its collateral standards
- Clinical data or a clinical trial
When wrestling with regulatory, quality and safety issues, executives fresh to the medical device industry often take uncertain or delayed steps as they navigate the path to becoming a medical device company. The biggest mistakes we see emerging medical device company executives make include delaying the development of their regulatory strategy and their quality system, which are critical components to the structure of Med Tech companies. Failing to attend to their development will only increase costs over time.
It is also vital not to misgauge the complexities and nuances of commercializing medical devices from a regulatory and quality perspective. Misunderstanding what it takes to comply with the regulations, build an adequate quality system or neglecting to adequately plan for demonstrating product safety will increases costs.
It is also a mistake to take regulatory or quality “short cuts.” In our experience, we’ve never seen a short cut in this industry that didn’t increase costs in the long run. For example, it sounds like a time saving step to buy a set of quality system templates and “fill in the blanks.” However, most packaged templates exhaustively represent the entire regulations line-by-line and tend to be built for organizations with at least a couple of dozen employees. The work required to integrate a system of templates to your particular product, company size and practices usually costs much more than the anticipated savings.
Ultimately, executives will save money by developing the infrastructure and processes that qualify their business as a viable medical device company. To save time, money and stress, develop and deploy the appropriate regulatory strategy, the most efficient and compliant quality management system (QMS), aggressively perform actions needed to demonstrate product safety… then keep it up.