Clinical trials are a complicated weave of science, clinical medicine, logistics, contract negotiation/business, and most importantly ethics. Many companies underestimate the difficulty and cost associated with implementing a clinical trial successfully.
A clinical research trial is just that; research with a null hypothesis. The outcome is not certain, and the first clinical trial is essentially a big “bet” that your device will be safe and/or efficacious. Sometimes, the gamble may be so large that in fact, if the trial fails, likely so does your product and/or company.
Medical Device clinical trials are expensive and can range from at least 1 million USD to greater than 10 million USD each. Hence it is important to start planning early so that the adequate funds can be raised to support the trial(s). Planning early allows your company to devise a strategy that can reduce both trial cost and time. In turn, this can reduce your time to market. Depending on your designation (Class II/501(k) or class III/PMA), the FDA (or your government’s notified body) will want to see varying levels of evidence that your device is safe and effective.
Furthermore, your investors and board will want to know that you have an internal clinical team, or Clinical Research Organization (CRO), or both, to design and implement the clinical strategy and trails. Investors will shy away from inexperience, equivocal/poor trial results, or a device that has a difficult reimbursement path. Any potential future acquisition deals will benefit from higher pricing for a device that has proven value to the payers. Once on the market, the payers (Medicare/Medicaid and/or private insurance companies) will need clinical evidence of value to support reimbursement.
If your regulatory and/or strategic path includes the need for clinical data, there are ways that an experienced CRO can help your company mitigate the risk, and go into the trial with the best possible design.