Program Management
Verification, Validation, FDA Strategy
Feasibility Studies
Production Scale-up
Automation & Smart Production
Product Design & Prototyping
Turning Medical Device Concepts Into Testable, Manufacturable Products
Birch Design helps medical device companies transform early ideas into practical, testable product concepts that are ready for development, clinical evaluation, and future manufacturing scale-up.
From the first sketch through functional prototypes, our approach combines product strategy, engineering execution, user needs, manufacturability, and program leadership. The goal is not simply to create a prototype that works once—it is to build a product foundation that can move confidently toward verification, validation, design transfer, and commercialization.
From Concept to Working Prototype
Early-stage medical device development is where many of the most important decisions are made. Product architecture, usability, materials, interfaces, tolerances, assembly approach, and manufacturing assumptions can all shape the cost, timeline, and long-term success of a device.
Birch Design supports teams through the critical early phases of development by helping translate clinical or customer needs into clear product requirements, design concepts, and functional prototypes.
Our product design and prototyping support includes:
Product concept development
User needs and intended-use definition
Customer and clinical workflow evaluation
Product requirements and design inputs
Mechanical design and CAD development
Proof-of-concept models
Functional prototype development
Feasibility testing and risk reduction
Prototype build planning and coordination
Design-for-manufacturability considerations
Supplier and prototype vendor coordination
Early manufacturing and assembly strategy
Product Design Support for Medical Device Teams
Birch Design can support a focused portion of product development or serve as a broader development partner for startups and growing medical device companies.
We work with clients on projects involving:
Catheter-based devices
Vascular access systems
Drug-delivery and insulin-delivery platforms
Steerable catheters and braided shaft assemblies
Sterile disposable products
Diagnostic-related devices
Urology products
Orthopaedic devices
Heart assist devices
TAVR and structural heart technologies
Automated assembly and manufacturing systems
How We Work
Birch Design offers flexible support models based on the needs of the program.
For Startups and Small Medical Device Companies
Birch Design can act as a hands-on development and program leadership partner, helping lead the product from concept through prototype, testing, regulatory readiness, design transfer, and commercialization.
For Established Medical Device Companies
Birch Design can provide focused support for product concepting, feasibility, prototype development, design reviews, manufacturing strategy, and project execution.
For Contract Manufacturers
Birch Design can work within an established manufacturing organization as an embedded or fractional resource, helping support customer programs, prototype builds, design transfer, and scale-up activities through the manufacturer’s quality system and laboratory resources.
Our Approach
Our product design and prototyping process is built around five core principles:
Start with the user need
Build a clear understanding of the clinical, customer, and business problem before defining the solution.Reduce risk early
Focus prototype effort on the highest-risk product, usability, manufacturing, and performance questions.Design for real-world use
Consider clinical workflow, handling, assembly, testing, and manufacturing from the beginning.Create a clear development path
Connect early concepts and prototypes to future requirements, testing, regulatory, and transfer activities.Build for scale
Make product decisions with future production, quality, supplier, and commercialization needs in mind.
Frequently Asked Questions
Still have questions? Take a look at the FAQ or reach out anytime. If you’re feeling ready, go ahead and apply.
-
We offer a range of solutions designed to meet your needs—whether you're just getting started or scaling something bigger. Everything is tailored to help you move forward with clarity and confidence.
-
Getting started is simple. Reach out through our contact form or schedule a call—we’ll walk you through the next steps and answer any questions along the way.
-
We combine a thoughtful, human-centered approach with clear communication and reliable results. It’s not just what we do—it’s how we do it that sets us apart.
-
You can reach us anytime via our contact page or email. We aim to respond quickly—usually within one business day.
-
We offer flexible pricing based on project type and complexity. After an initial conversation, we’ll provide a transparent quote with no hidden costs.