The field of med tech is constantly evolving, with new technologies and innovations emerging every day. However, developing a product in this industry is not an easy feat, particularly for startups. In the Med Tech Gurus Podcast episode #180, John Leavitt Lead Designer at Intelligent Product Solutions discusses some of the challenges that entrepreneurs face and offer some valuable insights to overcome them.
One of the biggest challenges for startups in the med tech industry is the FDA submission process. The approval process is long and complicated, requiring meticulous documentation and understanding of the different classifications of products. Entrepreneurs need to understand where their product falls in the category and which approval process they need to follow.
To overcome this challenge, entrepreneurs need to embrace the documentation process. This includes writing down the marketing requirements, product requirements, and business plans. By having everything written down and concise, entrepreneurs can share their vision with others and build a team.
However, entrepreneurs should also understand where they are in the development process and differentiate between a bench-top prototype and a human user-facing prototype. This helps them avoid unnecessary expenses and focus on the critical aspects of the development process.
Another critical aspect of the development process is risk assessment. By understanding the risks involved in the process, entrepreneurs can anticipate and reduce the burden of excessive documentation, change orders, and approvals.
Furthermore, becoming an expert in the problem that entrepreneurs are trying to solve is also critical. Entrepreneurs should be obsessed with it, develop a better vision, and write down their ideas to help organize their thoughts and develop the right rationale.
In conclusion, developing a product in the med tech industry requires entrepreneurs to focus on several critical aspects of the development process. By embracing the documentation process, becoming an expert in the problem, and understanding the risks involved, entrepreneurs can overcome the challenges and develop successful products.