Darren Nolen is the founder of Nolen Ortho and the inventor of the controlled activation technology enabling their products. Growing up on the wind-sept prairies, he obtained a degree in Mechanical Engineering at the University of Kansas. He focused on materials science, aiming himself towards a career in the petro-chem industry. The oil slump of the mid-90’s changed those plans, and he found himself designing and commissioning pharmaceutical production plants for engineering firm Clark, Richardson, & Biskup (CRB). Catching the travel bug, he spent the next ten years travelling the country, commissioning and validating new pharmaceutical plants for Bayer, Pfizer, Novartis, Baxter, Alkermes, and others. With a growing family, he settled in Cambridge working on Alkermes’ inhaled insulin project. Then, as sometimes happens in Cambridge, he got a job at this thing called ‘a startup’ – a company ready to change the world with a revolutionary protein crystallization technology, allowing injectable protein drugs to be taken as a pill. An exciting time followed, commuting between Cambridge and the Czech Republic, bringing a massive scale protein fermentation and purification facility on-line with partner Lonza Biotech. As startups come, often so they go, and the financial crisis of 2008/2009 sent Darren and family to Atlanta, Georgia where he worked for his first medical device company, CryoLife, cryopreserving human heart valves, formulating surgical adhesives for cardiovascular indications and creating engineered tissues in the form of soft-tissue repair patches and decellularized heart valves. Moving on to an in vitro diagnostic / biologics company, and missing the New England startup-innovation culture, he found himself spending most of this free time ruminating on tissue adhesives, how to make them better, how to expand their indications, how to develop a technology that would allow them to finally achieve their full potential. A year’s worth of early rising, fitting in a couple of hours each day before family woke and his day job beckoned, and he was ready to file his first IP for a new class of tissue repair adhesives; materials that could be formulated with its curing agent contained within, only solidifying after implantation. Paying the attorneys, and having the coveted “Patent Pending” in hand, Darren confidently waited for the big multinational device companies to come knocking on his door. Eventually, Darren learned the old adage from Thomas Edison, “Invention is 1% inspiration, 99% perspiration” did not stop at the first patent, that it applied even more to the world of entrepreneurship and medical device startups. And so, back to New England he came, Nolen Ortho was formed, and the march towards development and commercialization started. Along the way he has learned a great deal about how devices and biologics should be manufactured, how technology transfers should occur, how to identify, analyze, and mitigate risks, and the quality systems that must be in place for all this happen. Darren is joined by his wife Jennifer and three children who enjoy the clean air, natural beauty, and outdoor activities so plentiful in New Hampshire.