In this episode, Michelle and Duane discuss discuss her focus on startups, when to get a regulatory strategy done, why regulatory strategy is crucial and should be a part of your business plan, why you need to be careful when building your website, when it makes sense to use a stepwise regulatory approach, benefits to a De Novo pathway, could the US move towards MDRish regulations, and more.Michelle Lott LinkedInLeanRAQA WebsiteDuane Mancini LinkedInProject Medtech LinkedInProject Medtech Website