Topic: Getting Funding to Support a Startup
Explores funding pathways for medical device startups including SBIR/STTR grants, angel investment, venture capital, strategic corporate partnerships, and non-dilutive funding sources. Discusses how to align funding strategy with development milestones and investor expectations in the med-tech sector. Ensure market analysis, business case, and exit planning is well defined for a differentiated product.
Topic: Building the Team – What Does the Idea Need?
Discusses the makeup of a good startup leadership team and what steps can be taken early with a small group of experts. Reviews reasoning for insourced versus outsourced activities – what is the “secret sauce” versus what can be hired out? Introduces the idea of breaking down the bigger problem into smaller parts – where can simulation and pre-clinical work set the stage for successful readiness for requirements definition (next topic segue)
Topic: Establishing Requirements for First-in-Human Use
Covers the critical pathway from clinical need identification and definition of Specific Measurable Achievable Relevant Time-bound (SMART) requirements. Discusses strategies for design iteration to first-in-human (FIH) prototype readiness — including regulatory considerations, risk management, and design verification milestones specific to implantable and active medical devices.
Topic: How to get from Research to Commercial Development Readiness – Including Cybersecurity
Reinforces the need to build the right team, solve the right clinical, technical, and commercial problems, and what to have “in hand” when engaging a CDMO. Discusses what does “good enough” look like – how to put aside additional research for focus on executable commercial plans, that properly encompass Cybersecurity requirements and regulations from the start.
Dr. Peña is an Assistant Professor at the University of Minnesota, Twin Cities. His lab develops computational models that push the state-of-the-art to enable personalized neuromodulation therapies.