HealthForge Venture Studio accelerates the development of Class II 510(k) medical devices. We help startups transition from validated technology to market-ready products, backed by commercially viable business models that support faster exits and attract investment.
Startup teams accepted into HealthForge will receive training on the content investors do and don't want to see in a pitch deck, followed by an in-depth pitch-readiness assessment.
This comprehensive deep-dive critique will uncover strengths, weaknesses, and gaps in the core business model that should be emphasized or need to be addressed.
Then the real work begins as experienced med device development experts representing the following functional areas engage with the startup team in refining their business strategy, plan and budget:
Only after a solid, well-documented plan has been developed that contemplates potential risks and how to mitigate them, along with a realistic and right-sized product development plan and growth strategy, is a commensurately powerful pitch deck developed with the assistance of professional designers and writers.
We provide our founders with presentation coaching and the opportunity to practice and refine their pitches in front of a "friendly" but critical audience. If needed, we will also join them in presenting to investors.
Once they are ready, founders will have the opportunity to present to investors they've identified, as well as the hundreds of angel investors and high net worth individuals they'll have access to through HealthForge.
Every engagement starts with a regulatory review to evaluate your device's path to 510(k) clearance and outline the most efficient strategy for achieving it.
All HealthForge startups are provided access to a Quality Management System (QMS), a requirement for FDA clearance, providing a significant savings in money, time and effort versus investing in and setting up a stand-alone system.
Our cross-functional team supports V&V testing to confirm your device is safe, effective, and meets all regulatory requirements.
Our experienced engineers bring deep expertise across embedded software, electrical and mechanical systems, and software development.
Through our sister company, Bally Design, we offer over 50 years of award-winning industrial design and UX/UI expertise rooted in human-centered design principles.
Our seasoned project managers coordinate complex, cross-functional teams—keeping development on schedule, on budget, and on target.
We help identify and source the right-sized contract manufacturers—whether production is offshore, nearshore, or domestic—to align with your cost, quality, and scale objectives.
From defining market fit to driving growth, our marketing experts combine upstream and downstream strategies to ensure successful commercialization.
* The startups we typically work with are developing Class II 510(k) devices, but we will also consider ClassI devices.
NOTE: HealthForge Venture Studio uses gust.com to accept startup applications. If you do not currently have one, you will be prompted to set up a free account with gust.
Business Leader and strategic thinker with strong implementation skills. Expert in translating customer needs into marketing requirements that can be successfully designed and launched as new-to-the-market products or services.
Marketing Veteran with demonstrated experience and success in strategic marketing, marketing communications, product management, and business development. Skilled at market research, analysis, and brand building.
Efficiency Expert and creative solutions-focused problem solver, with experience in roles with national brands in the sports equipment, fashion and industrial product segments.
Bally Design applies a human-centered design philosophy to create innovative products that are as aesthetically pleasing as they are intuitive to use.
SDS develops software for embedded systems and IoT devices used in a wide range of markets, including industrial, governmental, and of course, medical.
Qualira leverages their deep industry expertise to navigate and execute the regulatory requirements of the FDA and global markets.
MedTech Dynamics assists startups with program management services that ensure a product development process that's on schedule and within budget.
The Barry Group is a full-service marketing communications agency offering website development, digital advertising, email marketing, CRM, list and database management, graphic design, and more.
Appalachian Investors Alliance (AIA) is a non-profit foundation working to revitalize the region’s economy through entrepreneur readiness. Over 400 accredited investor members across 11 states have invested in nearly 90 businesses.
