{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F82e07055-e0a9-46e0-bde0-3000b9fa5f94","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken","description":"What are the most common mistakes a startup medical device company usually make?\n\nHear Ronny Bracken candidly disclose how to avoid some very expensive lessons when starting out in the medical device business.\n\nWith 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.\n\nPresently 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.\n\nHis 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. \n\nRonny has a knack for creating intuitive, valuable, and innovative products that solve very specific problems in their markets. \n\nEpisode Highlights\n\n\u00b7 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.\n\n\u00b7 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.\n\n\u00b7 Merger and acquisitions and how it affects the small companies.\n\n\u00b7 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.\n\n\u00b7 How to balance your product research and commercialization. Valuable insights about your passion and funding.\n\n\u00b7 When to figure out what the market needs and why it\u2019s important to determine the product\u2019s purpose early in the development.\n\nRonny warns against falling in love with the invention, leaving no room for improvement or strategic marketing to generate revenue.\n\nFor 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\u2019s important to know early on if you have the right product for the right customer.\n\nThe patient may be the beneficiary but it\u2019s 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.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/3da9906d-b3bf-4967-acec-f1980853ddec/88ee53a0-cb58-43dc-bb1e-31d23af1c4ae.jpg"}