The key to making an impact in medical innovation
While medical innovation is advancing at a fast pace, only a portion of new ideas and technology make their way into the hands of patients and physicians. Navigating the complex environment of healthcare systems poses many challenges that make it difficult to commercialize healthcare products. As a biomedical engineer and clinical researcher, I spent a lot of time working with new technologies that directly impacted patient care. I was curious to understand what it takes to successfully develop a product that addresses a clinical need. In an effort to gain applied knowledge, I spent a year living in the hub of biotech innovation, the Bay Area, and learned from the brightest minds at UC Berkeley and UC San Francisco through the Master of Translational Medicine Program.
When I share that I have a Masters in Translational Medicine, I am always prepared for the inevitable follow up question: “Interesting….What is that?”
If you google translational medicine, you will find a definition such as: a rapidly growing discipline in biomedical research and aims to expedite the discovery of new diagnostic tools and treatments by using a multi-disciplinary, highly collaborative, “bench-to-bedside” approach.
Put simply, I view translational medicine as a field that illuminates the business fundamentals essential to advancing medical research and strategically applying technology to a practical clinical need. In order to make a real impact providing better care and treatment for patients, it is essential to not only understand the technicalities of biomedical engineering, but also have a concrete understanding of the product development cycle within the biotech industry.
Another term which is familiar to many scientists is “translational research”, which refers to the process of translating basic science from preclinical research to clinical research in humans. Translational research focuses on the science of proving safety and efficacy of a product. This research is a core component that generates evidence to support the development of medical products. The term “translational medicine” more broadly applies to the intersection of biomedical research, clinical needs, and business development.
Let’s walk through the translational steps and entrepreneurial aspects of translating medical innovation into clinical reality. The following are core components and questions to consider when developing medical technology.
Clinical Opportunity: What is the need you seek to address and the available market?
Prototyping: Can you ideate solutions to narrow in on the best approach?
Value Proposition: What value will your product deliver to your potential customers?
Intellectual Property: Do you have freedom to operate and is your technology patentable?
Regulatory Processes: Which pathway should you pursue for FDA approval?
R&D and Clinical Strategy: Which testing mechanisms or clinical trials do you need to perform to prove safety and efficacy?
Reimbursement Landscape: Who will pay for your product - government, employers, commercial payers?
Marketing: What is your competitive advantage and value add to stakeholders?
Sales & Distribution: Which channels of distribution will be most profitable?
While many of these components overlap with product development in other industries, there are several components that are unique to medical innovation and made complex by the intricate healthcare landscape. The first component in translational medicine is identifying the right clinical need that has a market potential. Acknowledging the components listed above and developing an overarching strategy prior to investing in research and development can help medical innovators succeed and avoid failure. This is often referred to as the “valley of death”, where scientists seeking to translate an idea from the lab to the market often run out of resources before they are able to become profitable from the product. Translational medicine aims to accelerate biotech product development by bridging the gap between research and commercialization.
I seek to empower individuals to take control of their health by developing tools and products that make a tangible impact. I encourage those interested in medical innovation to gain a holistic understanding of translational medicine in order to equip themselves with knowledge that will drive healthcare product adoption. Whether it be developing a consumer health product, physician utilized medical device, or lifesaving pharmaceutical, understanding the bigger picture of translational medicine will better position bioengineers to make that real impact.
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