MEDICAL DEVICE STARTUPS
Medical Device Development for Startups
Blur helps medical device startups go from concept to working prototype, through the FDA pathway, and into manufacturing. We guide you through the maze of developing on your budget, planning development around your funding milestones, building a minimum viable product first, and giving you an ISO 13485 quality system you can adopt as your own. We know the startup side because we lived it: Blur grew out of an ophthalmology medical device startup in Research Triangle Park, and startups we have worked with, including TearScience, Adaptec Medical Devices, and Momi, have gone on to be acquired. We work on many projects with startups from local universities as well as research universities around the country.
Realistic Goals
We have the in-house expertise to complete and manage all aspects of a medical device start-up. From design and engineering through manufacturing, clients leverage our internal systems and knowledge to help achieve their goals.
How We Help Medical Device Startups
We understand building medical devices and we understand building companies. There are tough decisions to make. You need a quality system, product strategy, great engineering, a smart regulatory path and manufacture leverage. All within a fixed budget. We get it.
- Early IP analysis
- Product strategy
- Product concepts
- COGS estimates
- Business planning
- Development planning
- Technology assessments
- ISO 13485 Quality System development
- Prototyping
- Investor strategy and Angel opportunities
- Startup clients working side by side in our building
- Government grant support
- Free on-site planning workshop for funded startups
Ready for Investor and Acquirer Due Diligence
We have been through major acquisitions, so we know how to prepare for technical due diligence, and we build documentation that holds up to scrutiny. For Adaptec Medical, we led all of the technical work and partnered with their sales, clinical, and marketing teams. Less than four years after program kickoff, Adaptec was acquired by BD, one of the world’s largest medical device companies.
An ISO 13485 Quality System You Can Adopt
Our ISO 13485 quality system, certified through Intertek under the Medical Device Single Audit Program (MDSAP), is developed and used every day by our team. Startup clients can adapt it as their own for a seamless quality pathway from development into manufacturing and beyond.
Startup Funding and Grant Support
Whether you are raising capital, writing grant applications, or showing investors a capable team is on board, we have you covered. We plan development around your funding milestones so each round buys real progress.
Working Prototypes, Fast
Our in-house prototyping takes you from proof of concept to a working prototype that brings the mechanical, electrical, and firmware work together. We solve the riskiest ideas first, so every dollar spent prototyping removes technical risk.
FDA Strategy, Right-Sized for Your Stage
Early on, we keep design controls lean so you can efficiently build an MVP, while capturing the product requirements that matter later. As the design matures, we scale to more robust design controls and our FDA submission summary document, so nothing has to be redone.
A Day With Our Engineers, On Us
For select startups, we host a free day at Blur where our engineers tackle your technical and system architecture questions alongside budgets and timelines. You leave with a clear plan of attack. Several of our startup clients even work in our building, side by side with our team.
From Lab to FDA Clearance
We work on many projects with startups from local universities as well as research universities around the country. We have commercialized university research all the way to FDA 510(k) clearance, and we know how to turn a lab breakthrough into a product investors and patients can count on.
Manufacturing Built for Startups
Traditional manufacturers struggle with startup realities: small volumes, stop-and-go demand, and shifting timelines. Our ISO 13485 contract manufacturing is built for that. The team that designed your device builds it, from pilot builds to production, so you have one partner from start to finish.
Come Meet the Team
The right partner comes down to the people you will work with every day. Come meet our technical experts: partners Keith Gausmann, Jeff Rosino, Scott Liddle, and Nathan Luck; David Moody, Director of Electrical Engineering; Kyle Matthews, Director of Firmware Engineering; technical project directors Dustin Simons and Erin Simons; and Britt Creech, VP of Operations.
STARTUPS ARE NOT FOR THE FAINT OF HEART
Survive the Valley of Death
01
Realistic Plan, Timeline, and Budget
You need a concrete plan and enough cash to develop, test, submit to the FDA and get revenues positive. Only through realistic planning and experienced compliance guidance can you accurately plan from concept through sales ramp-up. And a well thought out plan is only as good as the decisions you make during the process. We’ve been there, we’ve seen good decisions and bad. We will help. A typical program reaches design freeze in about 9 to 24 months, depending on complexity and starting point.
Bring it all together
Here's What's Next
03
Avoid Manufacturing Nightmares: Contract Manufacturing for Startups
Manufacturing as a startup is not easy. You aren’t taken seriously, and you need cash in order to buy components and get volume price breaks. You need information, relationships and leverage. We’ve been down this road and we’ve been successful. Now we’ve built this capability internally at Blur, using the strategies we’ve developed over the years to reduce risks and costs.
WHAT WE'VE DONE
Our Work
Frequently Asked Questions
How do I start a medical device company?
Before you build a company, know your users and your market, and who will pay for your device. Know the IP landscape and face your biggest risks head on: technical, regulatory, clinical, and sales. Prove the core idea works in the lab first. Then build a realistic plan and budget around your funding milestones, because running out of money is the top reason startups fail.
What is the medical device development process?
Medical device development moves through clear phases, and each one reduces risk before the next begins:
- Discovery and planning: define the clinical need, users, intended use, and likely FDA pathway.
- Requirements and architecture: define what the device must do and how the system fits together.
- Feasibility prototypes: test the riskiest ideas quickly and inexpensively.
- Detailed design: build alpha and beta prototypes and refine them through testing and user feedback.
- Design freeze: finalize the design for verification.
- Verification and validation: prove the device meets its requirements and serves its users safely.
- FDA submission and transfer to manufacturing: submit to the FDA and move into pilot production.
We write design controls for every phase, scaled to your stage so early work stays lean and nothing has to be redone later.
How long does it take to develop a medical device?
Most programs reach design freeze in about 9 to 24 months, depending on complexity and starting point. After testing and the FDA submission, pilot production typically follows 6 to 12 months later, based on manufacturing ramp and supply chain needs.
How much does it cost to develop a medical device?
Costs swing wildly depending on the device, its complexity, and where you are starting from. Even feasibility work can range from tens of thousands to hundreds of thousands of dollars, and taking a complex Class II or III device to design freeze can run several hundred thousand to several million. We give every company a detailed cost estimate that line-items each step of development, including outside costs like testing labs, tooling, and purchased components, so there are no surprises.
Do you work with university startups?
Yes. We work on many projects with startups from local universities as well as research universities around the country, and we have commercialized university research all the way to FDA 510(k) clearance.
Can my startup use your quality system?
Yes. Our ISO 13485 quality system, certified through Intertek under the Medical Device Single Audit Program (MDSAP), is used every day by our own team. Startup clients can adopt it as their own, from development into manufacturing.
Is your design and development process ISO 13485 certified?
Yes. We are certified to ISO 13485:2016 through Intertek under the Medical Device Single Audit Program (MDSAP), and the certification covers design and development, not just manufacturing. The design controls we write for your project, and the SOPs behind them, are audited by an independent registrar and by our customers. When a submission review or an FDA inspection looks at your design history file, it was built on procedures that have already held up to outside audits.
Why should a startup care whether its design firm is ISO 13485 certified?
Because your design history file becomes one of your company’s most valuable assets, and investors, acquirers and the FDA will all look at it. Many design firms say they follow design controls or are ISO 13485 compliant, but nobody outside has audited their procedures. The gaps show up late, in due diligence, an FDA request for more information or an inspection, and fixing them means design control remediation. In software and firmware, remediation takes real time and budget, often more than doing it right the first time would have. We know, because we do remediation for clients whose first design firm skipped it. A certified design process means the procedures were checked before your project started.
Can we audit your quality system?
Yes, any time. Our customers audit us regularly, and we welcome it. Seeing our procedures, records and floor firsthand is the best way to know your device is in good hands.
How do you help a startup plan its path?
For select startups, we host a free day at Blur where our engineers work through your technical and system architecture questions alongside budget and timeline, so you leave with a clear plan of attack.
By Keith Gausmann, Partner, Blur Product Development. Last updated November 6, 2026.
We're here to help
Incubating a Company is Tough
Starting a medical device company is not for the faint of heart. With Blur’s talented team in your corner we will confidently tackle challenges as they arise.