During the past months we have met with founders of 15 medical device startup’s in order to learn about their biggest challenges. We were especially interested in their struggles with gaining market access, because we knew from our ‘big company’ medical device experience, that this is not an easy task. Our goal was to look for patterns in challenges – and learn if we could help mitigate these challenges with a new product or service. These are a few of our learnings:
1. If you are going through hell – keep going
Churchill’s was not talking about building medical device companies, but his quote sure is relevant for some of these startup’s. Nearly all the startup’s we met had spent much more time and money than expected getting their first product ready for market. One of the common challenges was documenting the design and testing the product in a way that would be accepted by the regulatory authorities. Founders that had no or little experience in the medical device field often took year-long detours. However, most of them recuperated after an intense trial-and-error process. Their advice to new founders was to get experienced medical device experts on board quickly (as advisors or employees) – preferably people that had hands-on experience from running a medical device startup.
2. Everybody is working on manual paper-based processes
Another very surprising finding was that nearly all companies still based their Quality Management System (QMS) and Design History File on manual paper-based processes. Even companies that had an Electronic Quality Management System (eQMS) or digital content management (DCM) in place were printing and manually signing their records. The reason being that these systems were not validated and are therefore not ready for inspection by the regulatory bodies. Most medical device startup’s were simply using file folders and common file sharing tools like Box, OneDrive or Dropbox. This seemed to work well for a short period of time, until the manual process of printing and signing the documents became very cumbersome and time-consuming. Another finding was that many companies had lost track of which documents were still not signed and which version was the newest. Their advice was to think carefully about when the right time is to go digital. Because starting too early, when you are still ‘in the sandbox’, can cause a slow-down of the innovation process. However, waiting until a massive amount of documentation has been created is also a bad idea.
3. The perceived task of going digital is enormous
Migration. The task most people fear. Partly because it sometimes reveals a chunk of missing or unfinished business, but mostly because of the unknown amount of time it takes to get it done. When talking to the startup founders we often met the argument: “if we just knew how much work was ahead of us – or if somebody could help us migrate to a digital QMS – then we would do it”. It’s a tough call. You are already months or years behind on the product development and now you are asking your team to spend time on an activity like this. The key learning here was that the perceived task was often bigger than the actual task. Therefore, spending some time on doing a small pre-ject, where you analyze the actual task was recommended.
To summarize our findings all the startup’s were planning to fully digitize their QMS and DHF. However, most founders were not sure when was the right time to do this. We don’t have good answer for this question, because it varies from case to case. The timing aspect – or in other words “sandbox vs. design control” is an interesting subject, which we will look into in a later article. Please feel free to comment and share your own experiences.