While the enforcement of regulatory compliance maintains safety and effectiveness of medical devices, it stymies innovation in the medical marketplace. As ec52 discussed, the EU’s transition to implement new regulations on medical devices to heighten scrutiny on clinical trials and post-market compliance is transforming the medical industry on the global stage. The transformation of the regulatory framework is to minimize risks of medical devices on the market, but, as a side effect, will substantially increase the prices to introduce new products to market. If the FDA implement new regulations, the process for a 510(k), de novo application, clinical trials, premarket approval, and postmarket reporting will only becomes less efficient and more expensive. Only well-established medical companies will be able to afford the costs of having a project team to introduce Class II/III products that meets the FDA requirements for clearance/approval. The costs are already very high that make it very difficult for startups to disrupt the industry as mentioned by Ashley. However, new medical breakthroughs can lead to startups that can amass funds from venture capitalists and resources provided by business incubators. The barrier to entry will continue to get higher as stricter regulations are introduced, which undoubtedly limits competition and innovation, but with the premise of transforming medical industry with a startup device, investors can enable startups to enter the competition.