WE HAVE DEEP MEDICAL DEVICE EXPERTISE
FPD Medical supports the development of FDA-regulated devices where technical execution and regulatory alignment are critical. With over a decade of experience across complex medical systems, we apply ISO 13485–compliant processes to manage risk, control development, and progress efficiently toward commercialization.
Our work spans hardware and software, with experience aligned to IEC 62304, IEC 62366, ISO 14001, and IEC 60601—ensuring products are developed with the rigor required for safety, usability, and regulatory approval.
Numbers Don’t Lie. Over the last 10 years, we’ve launched:
16 Electrosurgical Tools & Generators
7 Respiratory Products
5 Benchtop Capital Equipment
7 Wearables & Monitoring Devices
13 Robotics & Automation Products
16 Orthopedic & Navigation Tools
244+ Patents
Talk Is Cheap, So Here’s How We Do It…
WITH SOME REAL LIFE EXAMPLES
REQUIREMENTS & CONCEPT
DEVELOPMENT
The quality of early decisions defines the success of a medical device. We apply structured Voice of Customer methods—including usability studies, persona development, and workflow analysis—to translate user needs into clear, testable engineering requirements.
Using rapid prototyping and focused concept evaluation, we develop and refine design directions quickly—enabling confident decision-making in days or weeks while minimizing downstream risk.
ENGINEERING & FUNCTIONAL PROTOTYPING
Functional performance is established early—or paid for later. We develop prototypes to validate critical subsystems, resolve technical uncertainty, and confirm architectural decisions before development is locked in.
Through rapid, controlled iteration, we move from concept to working systems quickly—applying experienced engineering judgment to reduce risk and support efficient progression toward verification and production.
VERIFICATION & VALIDATION TESTING
Verification and validation are where development risk is realized—or resolved. We design and execute V&V strategies that ensure full traceability from user needs through design inputs and verification results.
Our approach emphasizes early alignment, rigorous test planning, and controlled execution—reducing late-stage failures and supporting a predictable path to regulatory approval and production readiness.
MANUFACTURING TRANSITION & PRODUCTION
A product is only successful when it can be built reliably at scale. We manage the transition from development into production through product line setup, equipment validation, and comprehensive manufacturing documentation.
Our approach ensures alignment between design intent and manufacturing execution—reducing transfer risk and enabling consistent, repeatable production. We integrate with trusted manufacturing partners to support a controlled path to scale.
PROJECT MANAGEMENT
Execution depends on control and visibility. Each program is led by a dedicated point of contact responsible for maintaining alignment across scope, schedule, budget, and technical progress.
We provide structured updates and actively manage risks, decisions, and open items—ensuring issues are addressed early and projects progress without unnecessary surprises.
REGULATORY & QUALITY
Regulatory outcomes are determined by development discipline. We align product development with quality system requirements from the outset—ensuring design controls, risk management, and documentation are structured for regulatory success.
We support clients targeting the U.S., Europe, Canada, and other markets by preparing the technical foundation required for submission—reducing risk and improving the predictability of regulatory review.
YOUR RELIABLE PARTNER IN MEDICAL PRODUCT DEVELOPMENT
Complex product development requires clarity, control, and trust. We define scope, schedule, and deliverables up front—providing transparent project structure and eliminating ambiguity before work begins.
Our approach supports predictable execution while allowing for disciplined adjustments as requirements evolve. We work as long-term partners, supporting programs from early development through production and scale.
FPD has been instrumental to the progress and success of our company. The design creativity, engineering skills, and drive to complete critical tasks on time is why we consider FPD a key partner, an extension of our team.
Flying Pig Designs is one of those rare companies that just do what they promise on time and on budget. Their team is not only creative, but practical and energetic. I would recommend FPD over any other engineering firm I have worked with in the past!
FPD has been a trusted partner to us for several years due primarily to their consistency of execution but also due to their flexibility and adaptation to various pivots in our business and engineering objectives. They view our projects through the lens of our mission – our objectives are their objectives – and deliver.