In the world of healthcare innovation, bringing a product from concept to market is a journey filled with challenges, opportunities, and invaluable lessons. A recent Society for Biomaterials webinar, sponsored by the Biomaterials and Medical Products Commercialization Special Interest Group, shed light on the process. The webinar featured insights from industry experts, including Brad Day of Luna Labs, Dan Mazzucco of ZSX Medical, and Elaine Duncan of Paladin Medical.
Brad shared the story of TrueClot Blood Simulant, a patented ultra-realistic simulated blood for training EMS and military first responders in advanced bleeding control techniques. The journey began in 2011 when Brad secured an SBIR contract to develop a simulated blood product that could replicate clotting action for military bleeding control training. Since then, Brad’s customer-centric strategy became the cornerstone for developing a suite of bleeding control training products now sold in 30+ countries.
Key Insights for Medical Product Commercialization
The webinar panelists shared several crucial insights for navigating the commercialization process:
- Identifying and Validating Unmet Needs
- Focus on solving real market problems rather than answering interesting scientific questions. Don’t get caught in the trap of a solution looking for a problem.
- Embrace customer feedback as an integral part of product development, continuous improvement, and understanding market needs. Interview customers and let them lead the conversation. Ask customers what they don’t want – this often yields more useful information than asking what they do want.
- Work quickly toward developing a minimum viable product (MVP), using it to generate feedback and evolve product and business strategies.
- Be willing to pivot based on real-world use cases.
- Tackling Operational Challenges
- Securing funding is often the most challenging aspect. To convince investors, you must demonstrate capability “by actually being capable.” Focus on skills acquisition and team development.
- Leverage available resources such as the Virginia Innovation Commercialization Assistance Program (ICAP). There are many commercialization assistance programs to help accelerate promising commercial research ideas. Check with your local Small Business Development Program (SBDC), your state’s economic development authority, the NSF Innovation Corps (I-Corps) and the SBIR/STTR program.
- Push through uncertainties and continuously address questions as they arise. Implement de-risking strategies around product, quality, partners, market, team, and sales, and establish contingency plans. The biggest challenges are often the ones you don’t anticipate.
- Navigate the non-scientific environment. Learn to communicate effectively with non-scientists to convey the value of the product. Your product’s success in moving from R&D to prototype to product will depend not just on its technical capabilities but on a sound business model based on market insights.
- Prepare early to scale production. Recognize that moving from research scale to production scale is resource-intensive. Anticipate market demand and lay the groundwork for extensive product safety work and testing.
- Establish clear milestones and focus on end-user needs to streamline ideas and workload.
- Safeguard your innovation by protecting your intellectual property as early as possible. Learn about protections needed to establish and maintain your freedom to operate.
- Understanding Regulatory Landscapes
- Thoroughly understanding your regulatory agency and its perceptions of risk. Understand requirements as early as possible so you don’t make missteps requiring work to be redone and resubmitted.
- Learn everything you can about deadlines, labelling, documentation, and testing. Dig to see what products in your space have been approved and which products failed regulatory approval – and why.
The path from idea to market in medical and healthcare fields is indeed bumpy but can lead to groundbreaking innovations that improve patient care and save lives. By focusing on customer needs, embracing feedback, leveraging available resources, and continually adapting, innovators can navigate the complexities of commercialization and bring their products to those who need them.
Special thanks to Brad Day, Elaine Duncan, Dan Mazzucco, and the Society for Biomaterials, including Stephanie Steichen and Lauren Costella who served as moderators.
Learn more about TrueClot and other Luna Labs solutions.
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