Medical device development, manufacturing & commercialization services.
Hands-on engineering, FDA strategy and program leadership for medical device startups and growing companies, from first prototype to scalable production, with one team connecting every stage.
Start where your team needs the most support.
Some teams need a clear roadmap. Others need experienced leadership for a complex program. Others are preparing for manufacturing transfer and scale-up. Each entry point is scoped to the milestone in front of you.
Product Development & Commercialization Readiness Assessment
A structured assessment of where your program stands and what should happen next.
- Intended use, clinical need and user needs
- Prototype maturity and technical feasibility
- FDA pathway and evidence strategy
- Risk management and quality readiness
- Manufacturing and supplier readiness
- Prioritized gap list
- Milestone roadmap with budget ranges
- An investor-ready summary
Program Leadership
Experienced MedTech leadership without full-time executive overhead.
- Integrated roadmaps and schedules
- Engineering, regulatory, clinical and manufacturing alignment
- Design reviews and phase gates
- Vendor, supplier and partner management
- Budget and milestone tracking
- A program that stays organized and accountable
- Faster, better-informed decisions
- Milestones your investors can see
Manufacturing Scale-Up & Automation Readiness
Build for commercial production before late changes become expensive.
- Design for manufacturability and cost
- Contract manufacturer strategy and selection
- Design transfer and process validation
- Assembly, inspection and labor-content analysis
- Automation and packaging readiness
- A manufacturing and transfer plan
- CM short list and evaluation
- Automation roadmap tied to volume
Services across the medical device lifecycle.
Use one service for a defined problem, or combine them into an integrated program. Each maps to the stages of the MedTech process.
Product design & prototyping
User needs, requirements, mechanical design and CAD, proof-of-concept models and functional prototypes built with manufacturing in mind.
Feasibility testing, cadaver studies & preclinical planning
Bench test strategy for the riskiest questions, cadaver labs and animal study planning that build evidence in the right order.
Design verification
Test methods, protocols and reports that prove design outputs meet design inputs, coordinated with qualified test labs.
Design validation & human factors
Simulated-use and usability studies, formative and summative, that confirm the device meets user needs.
FDA strategy
Pathway and predicate strategy, Pre-Submission (Q-Sub) packages and an evidence plan aligned to 510(k), De Novo or PMA.
Program management
Fractional program leadership, integrated schedules, phase gates and partner coordination across the whole program.
Production scale-up & technology transfer
Design transfer, process development and validation (IQ/OQ/PQ), supplier qualification and contract manufacturer onboarding.
Automation & advanced manufacturing
Automation readiness, equipment specification and integration for throughput, quality and cost at volume.
Medical device packaging
Sterile barrier and packaging strategy, packaging validation planning and supplier coordination.
Smart production consulting
Production-line improvement focused on yield, throughput, quality data and scalable operations.
Flexible support models for every kind of device team.
Startups & small device companies
A hands-on development and program leadership partner, leading the product from concept through prototype, testing, regulatory readiness, design transfer and commercialization.
Established medical device companies
Focused support for concepting, feasibility, prototype development, design reviews, manufacturing strategy and project execution.
Contract manufacturers
An embedded or fractional resource supporting customer programs, prototype builds, design transfer and scale-up within your quality system.
Why teams choose Birch Design
- Development and manufacturing experience in one resource
- Strong medical device and automation background
- Flexible, fractional engagement model
- Direct access to trusted suppliers and contract manufacturers
- Practical, hands-on program leadership
- Early alignment of product design and manufacturing strategy
Small first steps. Commitment that grows with confidence.
We scope work to the next value milestone, so you never sign up for more than the evidence justifies.
Discovery call
We learn about your device, stage, funding and the decision in front of you.
Assess & scope
A Readiness Assessment or focused scoping defines the milestone, budget and plan.
Execute in stages
Targeted projects, milestone programs or fractional leadership, with a gate review at each step.
Transfer & scale
Contract manufacturer selection, design transfer, validation and scale-up support.
Contact Birch Design
Have a medical device concept, prototype, development challenge, or manufacturing milestone ahead?
Birch Design helps startups and growing MedTech companies move from early product development through FDA strategy, feasibility testing, manufacturing scale-up, automation, and commercialization planning.
Whether you need a clearer development roadmap, fractional program leadership, support preparing for clinical studies, guidance on manufacturing transfer, or a strategy for scalable production, we would welcome the conversation.
Share a little about your product, current stage of development, and the challenge your team is working through. We will help identify practical next steps toward a stronger path to market.