Priority Designs

Priority Designs is an experienced product development consultancy specializing in medical device development, usability engineering, and human factors validation. We help medical technology companies bring safe, effective, and compliant products to market faster. From early end user research, concept generation and industrial design, to engineering, prototyping, and formative & summative usability testing, our ISO 13485-certified processes ensure regulatory alignment and patient-focused outcomes. With decades of experience across Class I, II, and III devices, we partner with product teams to solve complex challenges, accelerate timelines, and reduce risk on the path to FDA approval.

Human Factors & FDA Compliance Experts

Developing medical devices requires rigorous human factors engineering to ensure proper usability and reduce the risk of use-related errors. At Priority Designs, our usability experts have deep experience with IEC 62366-1 and FDA guidance for human factors validation. We conduct formative and summative usability studies that mirror real-world conditions, ensuring devices can be used safely and effectively by clinicians, caregivers, and patients. Our human factors experience spans everything from drug delivery combination products, large scale X-ray systems, wearable defibrillators and clinical blood analyzers to surgical gowns, enteral feeding pumps and NICU infusion systems. By embedding usability engineering early in the process, we help clients avoid costly redesigns, streamline regulatory submissions, and improve patient outcomes.

End-to-End Medical Device Design and Engineering

Our multi-disciplinary team provides end-to-end medical device design and engineering under one roof. Industrial designers, mechanical engineers, electrical engineers, software developers, and UX/UI designers work side by side to deliver integrated solutions. Whether we are developing wearable health tech, surgical instruments, or diagnostic systems, we combine technical expertise with creative problem solving. Our in-house prototyping and testing labs allow rapid iteration, enabling clients to evaluate function, form, and manufacturability earlier. This holistic approach shortens development cycles while ensuring devices are safe, reliable, and user centered.

Wearable & Digital Health Device Development

Priority Designs is uniquely experienced in wearable medical devices and connected health technologies. Our soft goods and wearables team develops products that merge textiles with electronics, such as compression garments, orthopedic supports, and digital monitoring devices. With expertise in smart sensors, wireless communication, and embedded software, we help companies create wearables that are comfortable, durable, and clinically valuable. From concussion prevention devices to wireless fall detection devices, we’ve guided wearable tech projects through research, prototyping, and regulatory submission. Our experience ensures these products meet both patient comfort needs and technical performance requirements.

Rapid Prototyping for Medical Devices

Time to market is critical in the medical device industry. Our 30,000 sq. ft. prototyping lab accelerates development by delivering functional prototypes within days. Clients can quickly evaluate ergonomics, test mechanical reliability, and validate designs before committing to tooling. Unlike outsourcing to overseas vendors, our in-house team ensures confidentiality, speed, and close collaboration with engineers and designers. Whether producing CNC-machined housings, silicone tools, or fully functional electronic prototypes, we help reduce risk and move projects toward clinical evaluation faster.

Regulatory Support and Validation Testing

Medical device development is not just about design, it’s about ensuring compliance with FDA requirements. Our team integrates regulatory expectations into every phase of development. We help clients build usability files, risk analyses, and validation reports that withstand regulatory scrutiny. From moderating and reporting usability studies, to writing and testing validation protocols, we deliver the documentation and evidence required for submissions. By aligning design with regulatory pathways, we reduce the likelihood of delays and help clients launch with confidence.

Why Choose Priority Designs: ISO 13485-Certified MedTech Consultancy

With over 35 years of experience, Priority Designs has become a trusted partner for medical device manufacturers, health tech startups, and global healthcare companies. Our cross-functional expertise, ISO 13485-certified processes, and in-house capabilities make us uniquely positioned to deliver compliant, user-centered solutions under tight timelines. We’ve supported projects ranging from disposable surgical tools to enterprise-level diagnostic systems, always with the goal of improving patient safety and clinical effectiveness. Our “Ideas, Not Egos” culture ensures transparent collaboration, where client goals drive decision-making.

Our Story

Founded in 1990, Priority Designs began as a small industrial design firm and has grown into a multi-disciplinary consultancy of over 70 designers, engineers, researchers, and prototyping specialists. While our portfolio spans consumer, industrial, and sporting goods, our medical device development practice has become one of our most impactful areas of work. We remain an independent, employee-owned company, committed to helping clients develop safe, effective, and innovative healthcare solutions that improve lives.

Press Releases

Priority Designs to Showcase Medical Device Development Capabilities at MD&M West

Priority Designs, a think-bigger, move-faster product development company is bringing their 35+ years of experience to the 2026 MD&M West trade show.