We Help Physicians & Dentists Launch Medical Devices, Software, and Consumer Products—Successfully.
End-to-end product development for clinicians with an idea: design, engineering, prototyping, manufacturing sourcing, FDA regulatory navigation, and funding strategy—all under one roof.
Book a free 15-minute discovery call — no commitment.
navigation
& engineers
strategy
apps & consumer
Our Development Roadmap
- 1 Discovery & Concept Validation
- 2 Design & Engineering
- 3 Prototyping & Testing
- 4 Regulatory & Manufacturing
- 5 Funding & Market Launch
TRUSTED BY
Where Our Clients Launch
From regulated clinical devices to consumer health and lifestyle products—the same team and process powers every category.
Medical Devices
Class I & II devices, surgical tools, and clinical equipment.
Dental Products
Chairside tools, materials, and operatory innovations.
Health Software
SaMD, EHR-adjacent tools, and clinician dashboards.
Mobile Apps
Patient-facing apps, biofeedback, and connected experiences.
Wearables & IoT
Sensor-driven devices, firmware, and connected hardware.
Consumer Products
Retail-ready goods sold across Amazon, Shopify & major retailers.
Most clinical innovations die in the gap between idea and execution
You see the problem every day in practice. You know exactly what would solve it. But turning that insight into an FDA-cleared, manufacturable, fundable product is a different world—and most clinicians lose months or years navigating it alone.
Regulatory complexity
FDA pathways, classifications, and 510(k) submissions can derail a project before it ever ships.
Engineering & sourcing gaps
Clinical insight doesn't translate to design files, biocompatible materials, or vetted contract manufacturers.
Funding without a story
Investors back validated products with a clear path to market—not napkin sketches and clinical credentials alone.
Who We Work With
We partner with practicing clinicians and founders who have the clinical insight—and the capital to develop, prototype, and test before going to investors.
Physicians
Surgeons, specialists, and primary care physicians who've identified a clinical gap and want to build a device, app, or therapy that fills it.
Dentists & Orthodontists
Dental professionals creating better tools, materials, software, and patient-experience products for the operatory and beyond.
Clinician-Founders
Healthcare entrepreneurs ready to translate clinical experience into a fundable, scalable medical or consumer health business.
Full-Service Product Development for Healthcare Innovators
Everything you need to take a clinical idea from concept to commercialization—under one roof.
Concept validation
Pressure-test your idea against the market, the standard of care, and existing IP before you invest.
Industrial design & engineering
CAD, mechanical engineering, electronics, and human-factors design for medical and consumer products.
Software & app development
Patient apps, clinician dashboards, SaMD (software as a medical device), and connected-device firmware.
Prototyping & testing
Functional prototypes, bench testing, and iteration cycles to de-risk your design before tooling.
FDA regulatory strategy
Classification, predicate analysis, 510(k) pathway planning, and a roadmap for getting to clearance.
Manufacturing sourcing
Vetted contract manufacturers—domestic and overseas—chosen for the right scale, materials, and compliance.
Funding strategy
Pitch materials, financial models, and warm intros to angels, strategics, and grant programs (SBIR/STTR).
Launch & commercialization
Go-to-market strategy, branding, packaging, and channel selection for clinical and consumer markets.
IP guidance
Coordination with patent and trademark attorneys to protect your innovation before disclosure.
Navigate FDA Regulation Without Losing Your Roadmap
For medical devices and SaMD, regulatory strategy isn't an afterthought—it shapes your design, your timeline, and your funding story. We help you make the right calls early.
Device classification
Class I, II, or III? Exempt or not? We help you map your product to the right pathway from day one.
Predicate analysis
Identify substantially equivalent devices and structure a 510(k) strategy that leverages the cleanest pathway.
Submission planning
Design controls, testing requirements, and documentation strategy so your filing isn't a fire drill.
Regulatory partners
We coordinate with experienced regulatory consultants and FDA submission specialists when you need them.
One partner. The whole product journey.
Most clinicians end up stitching together a designer, an engineer, a regulatory consultant, a manufacturer, and a fundraising advisor—then quarterbacking the whole thing themselves. We bring it all under one roof, so your idea moves faster and you stay focused on what you do best.
Book a free 15-minute discovery call to see if we're a fit for your project.
Built for clinicians who are serious about building
We take on a small number of clinician-led projects each year so we can give each one the attention it deserves. You bring the clinical insight and the capital to develop, prototype, and test—we bring the team to make it real.
Discovery & De-Risking
We map your concept against the market, the regulatory pathway, and the cost-to-build before you commit to full development.
- Technical & regulatory feasibility
- Predicate & competitive analysis
- Development scope & budget
Build, Test & Launch
Full design, engineering, prototyping, and manufacturing sourcing—run in parallel with regulatory strategy and a funding plan for the next milestone.
- Functional, testable prototypes
- Manufacturing & supply chain setup
- Investor-ready package for production
Medical & Consumer Products We've Helped Bring to Life
A selection of recent projects across medical devices, health apps, and consumer products. The same end-to-end process is available to your clinical innovation.
Biofeedback · Mobile App
Vetta BioFeedback App
Connected biofeedback app paired with a sensor system—UX design, mobile development, and data architecture for a clinician-led wellness product.
Patient Hygiene Device
Bed Pan Bidet
Design, engineering, and prototyping for an in-bed patient hygiene device—improving dignity and clinical workflow for bedbound patients.
Respiratory · Critical Care
Airway System
Full product development of a physician-invented airway management system—mechanical design, biocompatible materials, and regulatory pathway planning.
Patient Warming Device
Medical Blanket Heater
Industrial design, electronics, and manufacturing sourcing for a clinical patient-warming device built to hospital safety and durability standards.
Cardiac · Implantable
LV Lead
Precision engineering and prototyping for a left ventricular cardiac lead—working through tight tolerance, materials, and regulatory considerations.
Tech Accessory
MOX Trackpad
Industrial design, mechanical engineering, and rendering for a consumer tech accessory—balancing ergonomics, precision, and manufacturability.
Pet Product
Pet Along
End-to-end consumer product development for a pet lifestyle product—design, prototyping, and manufacturing sourcing for retail launch.
Baby & Parenting
Pacifier Leash
Design, prototyping, and sourcing for a baby accessory in a competitive consumer category—built for safety, durability, and parent-friendly retail.
Free 15-minute discovery call—no commitment.
What You Walk Away With
Tangible deliverables you can hand to investors, manufacturers, and regulators.
A validated clinical & market case
Tested, functional prototypes
An FDA strategy & timeline
Vetted manufacturing partners
An investor-ready package
A launch & go-to-market plan
What's Included in a Full Engagement
- Clinical & market discovery
- Industrial & mechanical design
- Electronics & firmware (as needed)
- App & software development
- Functional prototyping
- Bench & usability testing
- FDA pathway & predicate analysis
- Manufacturing & supplier sourcing
- IP & legal coordination
- Investor pitch & deck support
- Funding & grant strategy (SBIR/STTR)
- Branding, packaging & launch plan
What Our Clients Say
From medical device founders to consumer-product entrepreneurs—here's what working with our team looks like.
"Working with Stoke has been great & more human than other product development firms we've used. They develop products with the whole business process in mind — from material and manufacturing sourcing to fulfillment and marketing — and that has saved us headaches before they even began (and saved us a lot of money). I can't recommend them enough!"
— Evan Hajas"Andrew is the consummate professional. If he says he's going to do something, not only does he do it, he does it quickly. His communication is flawless, never left anything lingering or waiting. And on top of that, his work is impeccable. He is very thorough and complete with each project."
— Ian Soane"Andrew has been awesome to work with. He is timely with revisions, he's very knowledgeable when it comes to the practicality of product development, and he is excellent at sourcing with manufacturers."
— Kaden Sego"What an adventure with Stoke Ventures! Great communication, follow up, and customer service is second to none. Shout out to Carter for always taking the time to keep me updated with any and all necessary intel. 10/10 Recommend."
— Josh Imbrogno"Andrew did a great job helping us create some parts that we needed, enabling us to launch a new business. He designed CAD files for five different parts and worked with us back and forth until our vision was perfected! Andrew was flexible and worked with our schedule. Thanks, Andrew."
— Jeanna Frye"Andrew went above and beyond for our prototype! Trustworthy and quick responses. Stoke Ventures was an absolute pleasure to work with and we are excited about working with them in the future! I highly recommend Stoke Ventures for those needing a next level prototype!"
— Rachele PaulusYour Clinical Insight Deserves a Real Product.
Design it. Build it. Get it cleared. Get it funded. Launch it.
Book a Call HereBook a free 15-minute discovery call—no pressure, no commitment. We'll talk through your idea and tell you honestly whether we're the right fit.