I agree with what was said in previous posts about regulatory compliance challenges, but I also think these challenges will only increase at least for the next 10-20 years. Given the EU Medical Device Regulations (MDR) 2017/745 that will take effect in mid-2020, EU is now driving the requirements for Medical Devices in my opinion, and it will not take too long for the World to follow, including FDA. With the new MDR, the company clinical data and Clinical Evaluation Report (CER) will face heavy scrutiny and require recurring updates. In addition, the company will have to increase post-market surveillance requirements, perform more Post-Market Clinical Follow-up (PMCF) studies, and deliver Period Safety Update Reports. All these activities will increase costs and funds necessary to market a medical device and keep it in the market. From a project management perspective, large companies surely have funds necessary to accommodate for these new MDR requirements, however small companies will definitely have to assess their budget to ensure they have the means to pursue development of the medical device.