How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

What are the most common mistakes a startup medical device company usually make? Hear Ronny Bracken candidly disclose how to avoid some very expensive lessons when starting out in the medical device business. With his 26 years of Research and Development experience for medical product development at the executive level, he will show us how to avoid a $20 million haircut on your valuation because your design controls and quality system are not up to speed. Presently Ronny is the Principal at Paladin Biomedical Consultants, LLC, as well as chief operating officer for a tissue engineering startup and an antimicrobial medical device startup. His extensive experience has guided a lot of companies to have a solid business model that brings in revenue, ensuring sustainability of the projects in which he is involved. Ronny has a knack for creating intuitive, valuable, and innovative products that solve very specific problems in their markets. Episode Highlights · Common mistakes that small companies make and how to do the right thing, graciously pointing out the aspects of the business that small companies need to focus on. · His points of view regarding treating the regulations asa way of life, why embracing risk management practices is the key and how to have design controls that work. · Merger and acquisitions and how it affects the small companies. · How to create a team from research and development to the marketing aspect of the business. From manufacturing the product to bring it to the market. · How to balance your product research and commercialization. Valuable insights about your passion and funding. · When to figure out what the market needs and why it’s important to determine the product’s purpose early in the development. Ronny warns against falling in love with the invention, leaving no room for improvement or strategic marketing to generate revenue. For him, in order for a product to be profitable, it needs to listen to customer feedback. He relates an interesting point view about losing early, for him it’s important to know early on if you have the right product for the right customer. The patient may be the beneficiary but it’s the medical practitioners who are the purchasers of the medical equipment. So it's still important to design a product that they will need and at the same time stay compliant with industry standards.