Clinical trials may be the biggest barrier to market for many Drug and Pre Market Approval (PMA) medical device start-ups. Clinical trials require both experience and expertise and can be expensive and challenging.
Many start-ups fail due to lack of a good clinical development plan and/or a poorly designed clinical trial. If a startups exit strategy is acquisition, the big companies are going to want FDA clearance and/or very solid evidence that the device is safe and effective along with evidence base that supports reimbursement.
Our recommendation is to begin planning for it in your first round of fundraising. It will takes longer and be more expensive than you think it will be.
Clinical evidence is also valuable for 510(k) devices in terms of supporting a value proposition for the surgeon, hospital executives, private payers, and CMS. There are methods for an efficient trial design for an affordable investment, with a great return.
