One of the best ways ambitious achievers can find an edge within their industry is to listen and learn from the experiences of others who have succeeded in their field. And there is certainly no disputing the incredible success of medical device entrepreneur and investor Rudy Mazzocchi, who is currently the CEO of Elenza.
Rudy’s incredibly impressive medtech career includes obtaining more than 50 patents, as well as founding or co-founding 11 companies across several medical specialties including cardiology, oncology, orthopedics, neurosurgery, and embryonic stem-cell development. His latest achievement: Rudy authored a controversial medical thriller titled ’Equity of Evil’ which draws on his own industry experiences.
Based on my interview with Rudy Mazzocchi, I was able to extract 8 actionable insights you can use today in order to become a lynchpin within your company.
Here are the 8 Action Points from my Interview with Rudy Mazzocchi:
If you don’t have time to read them now, take these 8 action points with you by clicking here.
Compared to a Few Decades Ago, Clinical Validation Takes Much Longer to Achieve but Remains a Key Valuation Driver in Medical Device Development
Rudy started his career in the early 1980s when, as he fondly recalls, you could sketch your idea out on a napkin, have your engineers prototype it, get FDA approval in 90 days, and commercially launch within 6 months. Today’s medtech environment is obviously very different. For example, the average PMA is now estimated to be 4 to 5 years. Today, the slower process and extra capital required can have a big impact on a company’s success. With that said, clinical validation is still the key valuation driver for any medical device company. Solid clinical data enables a company to get to the next inflection point and raise more money.
To Find and Validate a New Concept, Ask Simple Questions in Order to Uncover Unmet Needs
If you ask the right questions and listen hard enough to the responses, you will find your unmet need. Rudy explains that by witnessing surgical procedures and asking simple, yet necessary questions, such as ’How can this be improved?, ’How can it be done differently?’ and ’How can we optimize the efficiency of this procedure?’ he has managed to successfully tap into these unmet needs on many occasions.
Deconstruct the Components of an Idea to Assess the Feasibility of the Concept
Although Rudy describes his approach as sometimes ’jumping down rabbit holes to chase opportunities’, he also acknowledges that you have to come up for air from time to time in order to assess the feasibility of the idea for the proposed medical device. It is important to know when to bail on an idea and if necessary, bail fast. An example he uses to illustrate this point is that of an electroactive implantable intraocular lens being developed by Elenza for cataract patients. By breaking down all of the components for the lens – from the liquid crystal chemistry to the power cell and chip required to run the algorithm ’ Rudy and his team were able to conclude that all of the requirements were indeed viable and available for fabrication. This example also highlighted a case in which the FDA actually assisted in providing consultative advice specific to the approval process. Sometimes the FDA can truly be helpful. Sometimes.
Success is Dependent Upon Finding Your Position within Large Strategic Companies Early On in the Process
Increasingly, large strategics with deep pockets are co-investing early on with venture capitalists. And in an age where capital can be hard to find, Rudy believes this isn’t necessarily a bad thing. A partnership can solve early funding issues and may be the near-term solution for many smaller companies. To position yourself early on, you need to first develop solid technology that appears to be a threat to the existing franchises within large medical device companies. From there, it is extremely vital that you are careful in structuring the deal. In many cases, a partnership is the only option as many investors are hesitant to get involved pre-clinical or pre-revenue. In fact, many investors won’t take on a company that does not have a reimbursement pathway. More so, some investors will completely back away if a PMA is required. The key lies in finding the right investor for your niche and the particular stage of your business.
Outsourcing Specific Expertise in the Medical Device Development Journey Can Have Several Advantages
By outsourcing 80-100% of the actual development of the medical device, Rudy is able to utilize pockets of expertise from best-in-class engineers across the world. In addition, this model allows for huge financial savings in comparison to building an in-house engineering team. By employing a very small management team and outsourcing everything else, you can scale up or down very quickly in response to the business needs. Also of note, international engineers will often hand over all intellectual property, in contrast to US engineers that wish to control IP, resulting in royalty charges and additional expenses.
Obtaining Capital is the Only Hurdle in a World of Unlimited Innovation and Engineering Resources
With the limitless resources and engineering talent available, innovation is inevitable in today’s world of medical device development. The primary concern is access to capital in order to get from concept to commercialization. Clinical validation is heavily dependent on capital. With that said, one way in which money can be saved is by conducting trials in Europe, particularly in Eastern European countries. Many medical device companies are now seeking CE mark approval before they even think about US regulatory approval because of the increased financial burden of the US regulatory system.
Rudy’s New Book ‘Equity Of Evil’ Highlights the Increasing Political, Ethical, and Moral Dilemmas Faced by the Medtech Industry and Society as a Whole
Rudy describes ‘Equity of Evil’ as a dark, bold, and controversial novel. In writing the piece, Rudy drew upon his own experiences gained in the field of human genetic engineering, where he was involved in pioneering drop cultures using organs obtained from aborted fetuses. Rudy was careful to ensure that the book was neither pro-life nor pro-choice, so the reader can find value from it regardless of their own perspective. The suspense-filled thriller reflects on the atrocities of society as well as the political and ethical issues regarding advanced and innovative medical technologies. You can buy the ebook from Barnes & Noble, Amazon, and iTunes. There will also be a print release later in the year. Also, don’t forget to check out the book trailer here.
Ambitious Medtech Doers Should Find Their Niche and Play to Their Own Strengths
Rudy’s lasting piece of advice: To be successful, you must find your niche and don’t be afraid to stick with it. For example, despite being given the opportunity to become the CEO of a large medtech company, Rudy recognized that he was a ’start-up guy’, and turned down the offer. Admittedly, there are a lot of risks within the start-up environment. However, Rudy recognizes that his strengths lie within the start-up space and he has made a conscience choice to stay there. He encourages other ambitious medtech doers to do the same – take the time to discover your strengths and stick to them!