Senior Director of Business Development, Neo-Bionica

Vice President, Sales & Business Development, Avio Medtech

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.

Chief Executive Officer, Neo-Bionica

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)

CEO, COFORCE

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.

Co-Founder and Chairman of the Board, Velentium Medical

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.

Head of Engineering & Technology, Cirtec Medical

Topic: Designing for Reliable Scalable Manufacturing

Discusses the importance of Design-for-Manufacturability (DFM) principles and how early engagement with CDMOs can shape product architecture, materials selection and process development for scale-up, tolerancing strategies, design control and quality system requirements to enable a smoother journey from early feasibility prototyping through clinical trials and validated high-volume manufacturing.