Medical device start-ups, particularly those whose product is software-enabled, face many challenges in the journey from initial startup, through the development process, to launch and beyond.
This article discusses some of the real software-related issues medical device companies have to address in order to navigate the process successfully.
The content for this article derives from interviews conducted with an actual medical instrument start-up, and therefore intended to be informative, actionable and of tangible benefit to any similar company at the startup stage.
There are numerous pitfalls you definitely want to avoid at the inception and early developmental stages of your business. After reading this article, you’ll have an invaluable insight into the actual experiences of a medical instrument and software development start-up that has already navigated the route you may be contemplating.
Armed with this knowledge, you will be in a better position to avoid some of the mistakes made by a typical start-up, saving you time, money and wasted effort in the process.
Let’s begin by looking at the background of the company we interviewed.
At the time of our interview, the company had actually been going for about 10 years.
The business started with a Chinese Research Cardiologist who had access to a large patient database, including final outcome data and a lot of AKG data. The Chinese government had already done some research using single processing, to see if they could predict disease state while patients were still sub-clinical or asymptomatic and unaware that they were sick.
Time and investment money were spent over a period of about eight years, technology was developed and several prototypes built. Despite this, the technology was never successfully productized. Early prototypes all had issues with either the hardware or software component and eventually investment funding ran out. Understandably, investors were frustrated after eight years of not having a deliverable product.
It was at this stage a new management team stepped in, and we pick up the story.
Clinical Data, Investors and the FDA
Medical device companies can often find it difficult to get any level of institutional investment without solid clinical data.
In the case of our company, theirs was a diagnostic device as opposed to a therapeutic product. This is an important distinction as you don’t need clinical data for a device that is classed as diagnostic.
If, on the other hand, you’re producing a therapeutic device you really need to show its efficacy and back this up with solid clinical data. The data has to be submitted to the FDA in the first instance, but it is also important in supporting any bid for investment capital.
Basically, if a device is efficiency and economics driven, clinical data is not required.
In fact, our company had some clinical data available, but all of it was run by the research cardiologist involved at the outset. Should they have been required to submit clinical data, this would have been far from ideal. There would always be the suspicion that the data may have been scrubbed or the trial designed to give favorable looking results.
It was clearly best practice to use an independent clinical researcher as that was exactly what institutional investors consider important when a pitch for funding is made. In the case of the company interviewed, they were fortunate to have enough private investors in any case; investors who believed in the technology enough so that institutional money wasn’t required early on.
That is not always the case, of course, so it is necessary to keep the need for properly conducted, independent clinical research data firmly front of mind, should it be required.