We recently identified key early focus areas for medtech startups. Now, we'll cover common startup pitfalls.
Misunderstanding regulatory terms
The first pitfall is misunderstanding regulatory terms. Always review how each jurisdiction defines terms. For example, 'MDR' has different meanings: in the EU, it refers to the Medical Device Regulation, while in the US FDA context, it stands for Medical Device Reporting, which is the process of submitting device-related adverse events. The same acronym can confuse if not clarified.
Another example is the confusion of terms when something is not happening as intended. In software, an unexpected issue is referred to as a 'bug,' while under ISO 13485 (a standard for quality management systems), a similar issue may be termed a 'non-conforming product.' These terms refer to different but related issues, and using them appropriately is crucial.
If your device needs to comply with several regulatory frameworks, please create a glossary in your QMS. This ensures you use the same language as your assessors and business partners.
Design and development process
A second common pitfall concerns the design and development process itself. In this domain, we see two different mistakes being made:
The first one is not implementing a design freeze at all and continues to develop and strive for a perfect product. An ideal product does not exist, and after a while, the design should be frozen to start testing and sales. After the initial release or during it, you can still work on a second version to improve certain specifications and possibly include additional claims.
Another pitfall is defining an MVP but not documenting design decisions. This means the DHF cannot be adequately filled.
Related to documentation, the next topic is something that, if solved correctly, can also support the design and development process
Managing QMS documentation.
The third pitfall is managing QMS documentation—doing too little or adding too much too soon.
Start with documented procedures like design and development and document control. These help you know what to record and how to store it. This way, you can use this information in your submission file. Let the number of procedures grow over time. Then everyone can get used to working under a QMS, which helps long-term. If you implement too many procedures too early, maintaining them takes too much time and is not yet needed. For example, why keep a complaint procedure for years when you are not on the market?
Submitting incomplete files to a Notified Body
Finally, the last pitfall is not just for startups, but it is also common among many manufacturers: submitting an incomplete file to the NB. This will delay the entire process and increase costs due to additional hours from the NB.
You can avoid most pitfalls by working with an experienced partner. They know when to act and can help you implement the proper procedures efficiently. If you need assistance, please don't hesitate to contact us.