From first concept to clinic, clearance and commercial scale.
Birch Design is a Twin Cities medical device consultancy. We help startups and entrepreneurs design, test, regulate and manufacture new medical technologies, with senior leadership that connects engineering, FDA strategy and production from day one.
One experienced partner for the whole device journey.
Most medical device programs don’t fail on the idea. They stall in the handoffs: prototype to design controls, testing to FDA, R&D to the contract manufacturer.
We work across all of those handoffs, so the decisions you make today still hold up at submission, in the clinic and on the production floor. You get senior people who have done the work, not a hand-off to junior staff.
Startups & entrepreneurs
Turn an idea, prototype or feasibility data into a funded, executable development plan.
Clinicians & inventors
Translate a clinical insight into requirements, prototypes and a realistic path to market.
Growing device companies
Add senior engineering, program and manufacturing leadership without a full-time executive hire.
Eight stages from idea to market.
Every medical device follows a version of this path. The order matters as much as the work: building the wrong thing, or the right thing too early, is the most expensive mistake in MedTech.
Senior expertise where device programs get stuck.
Engineering, regulatory, clinical and manufacturing work are planned together, so each phase sets up the next one instead of reopening it.
Product design & prototyping
User needs to functional, testable prototypes built with manufacturing in mind.
- User needs & design inputs
- Mechanical & electromechanical design
- Rapid prototyping & iteration
Verification, validation & human factors
Test strategies that generate evidence you can rely on at submission.
- V&V planning & protocols
- Formative & summative usability
- Risk management (ISO 14971)
FDA & regulatory strategy
A defensible pathway and evidence plan, informed early by FDA feedback.
- 510(k), De Novo & PMA strategy
- Pre-Submission (Q-Sub) packages
- QMSR-aligned design controls
Feasibility & preclinical
The right studies in the right order, from bench to cadaver lab to animal model.
- Feasibility test planning
- Cadaver & animal study planning
- First-in-human readiness
Program leadership
Fractional, senior program management that keeps scope, budget and milestones aligned.
- Integrated roadmaps & phase gates
- Vendor & partner management
- Investor-ready milestone plans
Manufacturing, automation & packaging
Design transfer, contract manufacturer selection and scale-up done deliberately.
- DFM & cost of goods
- CM selection & tech transfer
- Automation & sterile packaging
Engagements sized to your stage and budget.
Start with a focused assessment, add targeted expertise, or bring us in to lead the program. Every engagement is scoped around the milestones that matter to your next raise.
Product Development & Commercialization Readiness Assessment
A structured review of where your program stands across design, regulatory, clinical, quality and manufacturing. You leave with a prioritized gap list and a roadmap you can execute or share with investors.
- For concept, prototype or feasibility-stage programs
- Regulatory pathway and evidence plan
- Next milestones with realistic budget ranges
Targeted expertise
A defined problem, solved: a DFM review, a test strategy, a Pre-Sub package or a contract manufacturer search.
Milestone programs
Fixed-scope phases tied to value-inflection points such as design freeze, first-in-human or submission.
Fractional program leadership
Senior program management and engineering leadership, part-time, for as long as the program needs it.
Development through manufacturing
End-to-end support from design and V&V through design transfer and contract manufacturer onboarding.
Right problem. Right partner. Right time.
Three principles behind every program we lead, and the questions we help founders answer before money is spent.
Right problem
Validate the clinical need, the user and the economic buyer before the design is locked. Clinicians, hospitals, payers and patients all have to say yes for a device to be adopted.
Right partner
Match the partner to the stage: specialists early, a development partner for complex builds, and a contract manufacturer chosen for flexibility and fit, not just price.
Right time
Spend to the next value milestone. Each phase should retire a specific technical, regulatory or market risk, so every dollar raised buys measurable progress.
How long, and how much, will your device take?
The MedTech Journey Planner models your timeline, capital needs and partner decisions, from raising funds to choosing a design partner and a contract manufacturer.
- Stage-by-stage timeline and budget ranges
- When your cash runs out versus your next value milestone
- When to select a design partner and a contract manufacturer
- Device class, regulatory pathway and FDA user fees built in
Hands-on experience across clinical areas.
Our leadership has developed, tested and industrialized devices across a wide range of clinical areas and manufacturing technologies.
Insights for medical device founders.
Practical articles on development, FDA strategy, clinical planning and manufacturing, written for teams building their first device.
Commercialization readiness: what investors expect
Seven questions to answer before your next raise, from design inputs to an integrated roadmap.
Read the article Clinical & preclinicalConcept to first-in-human: a medical device roadmap
How bench, cadaver, animal and early clinical work fit together on the way to first-in-human.
Read the article ManufacturingWhy startups should plan for manufacturing early
The cost of deferring DFM, packaging and contract manufacturer decisions until after design freeze.
Read the article
Start the Conversation
Tell us about your project, company, or development challenge. Birch Design partners with medical device innovators to guide product development, regulatory strategy, and manufacturing scale-up from concept through commercialization.