Editor’s Note: This is reposted by permission. The founder of Core Input is Alvin Tai.
There is no denying that the digital and mobile health space is growing. And while there continues to be a need for capital equipment like x-ray equipment, MRIs and endoscopic surgical tools, venture capitalists are looking for the next major shift in healthcare.
According to Rock Health, a healthtech incubator in San Francisco, the investment into this industry is growing at a rapid rate. The funding into this space is reaching valuations greater than the last three years combined.
With more companies entering this space, there is an increasing need to re-evaluate the regulations. The FDA recently released a guidance document on mobile medical devices, which is preliminary at-best. The definitions are ambiguous and the interpretations for the regulations can differ greatly.
Quality System Development
Quality systems are typically a sore spot for early-stage medical device companies as it is seen as a process that slows things down and burns resources. It is nearly impossible (and unnecessary) to develop a full-fledged quality system all at once.
Here are some key areas to focus on for a small medical device company:
- Start with the submission : Focus on what documents you need to submit for your PMA/510k/IDE/international clearance. At this point in time, all that matters is to get a submission out the door because if you run out of time or money during this process, a quality system will not matter.
- Develop document control and design control processes : Once you have a handle on your submission, look into how you can control your documents and continue building your Design History File. Save every revision of your design documents, test reports, specifications and more. Unfortunately, early document control is typically manual.
- Streamline manufacturing activities and documentation : As you move away from prototype labs, focus your attention on developing the manufacturing process, creating Device History Records, assembly procedures and more. Software companies should be developing processes for compiling and releasing software in a controlled manner.
- Develop procedures for Complaint Handling and Corrective Actions (CAPA) : Once you begin selling (or even begin clinical trials), you need to record customer feedback. In fact, this becomes the FDA’s first priority during routine inspections. Be sure you have a plan to handle complaints and CAPAs before you start shipping goods.
- Complete other areas of the Quality System Regulations (QSR): It is important to develop those initial systems first, but you are not done. You have to finish the rest of the QSR: purchasing, acceptance criteria, servicing and more.
After registering with the FDA, your company is added to an elite list with other manufacturers that are routinely inspected. One of the best resources to learn about what the FDA is looking for can be found on the FDA website.
By far, the most consistent observations written up by the FDA every year deals with complaints and CAPAs. It is crucial to establish adequate and compliant processes for these parts of the quality system early on. We work with many companies going through audits and inspections, and it all boils down to keeping calm, being honest and providing relevant on-topic answers.