Responding to one of bnb6’s questions, I feel clinical trials (depending on the product and its intended market) are very expensive and can be very time consuming, but are critical in proving the quality of the product. I don’t believe that clinical trials should affect product innovation. Innovation provides the ability to advance the technology and practices in the medical industry. After innovating, then the product is weighed on its risks and benefits for the company and the market before even being considered for clinical trials. I don’t think clinical trials should be viewed as restricting creative ideas, but as the process required to prove the product’s safety in its intended use. If it’s a new product to the market where it’ll require a Pre-market Approval (PMA), clinical trials should be very stringent to satisfy all regulatory requirements. If the company has already launched a similar product into the market, having previous data and traceability of equivalency, clinical trial requirements are decreased, but not by any means relaxed. The clinical trial tasks are based on the product’s class, its amount of risk, and its quality management. From what I have experienced in the industry, for a basic glucose meter design, a clinical trial timeframe is minimally 5 months. The trail site needs 1 month to set up the equipment, train the healthcare professionals and recruit participants. To run the actual trial takes 3 months and then to analyze the data and write the report, used in regulatory submissions, takes another month. This isn’t with the consideration that before committing to the clinical trial, months of reliability tests are initially done with the first batch of pre-production meters. Then pre-clinical trials are conducted ensuring the product being used for clinical trials will guarantee high quality results. Then after the clinical trials are completed, the regulatory submission time for the FDA is 7-9 months, for Canada Healthcare approval is 3-4 months, and for Europe’s CE-mark submission it takes 2-3 months.