In our experience, the most common mistake medical device manufacturers make is to conduct clinical trials they design themselves without a reimbursement consultant’s input. A study which results in adequate scientific evidence to prove that your medical device is effective in improving the clinical outcomes of patients is crucial for you to obtain coverage from insurers. To accomplish this, most companies, especially start-ups, choose a case series design because it is most practical, easy to conduct, requires less time and doesn’t cost huge amounts of money. In a case series, the clinical course of a group of patients treated by a medical device is tracked over time and observations are made to see if their medical condition improves. However, there are disadvantages in that they are uncontrolled studies and do not compare their results with the current standard of treatment to prove its superiority. Moreover, one does not really know that these patients would have gotten better on their own and it does not prove that the treatment was the single factor that caused the improvement in health.
To have the best chance of gaining coverage from insurers, the gold standard in study design is a large, prospective, multicenter, randomized controlled trial (RTC), preferably blinded. Most other clinical study designs are usually not accepted by payers because they involve too few patients and, although the results may be good, the study design used to arrive at the results is significantly flawed and unreliable. To spend hundreds of thousands of dollars on a study that at the outset is doomed to be inadequate to obtain coverage is a huge mistake. While conducting your clinical trial(s), it is important not only to generate the scientific evidence with validated and reliable results, but also to gather economic data for a cost-effectiveness analysis to present assurance to insurers that use of your medical device will decrease their overall costs.
Hope this helps,