Medical Device Design

Pushing Innovation, Grounded in Years of Experience

Healthcare is challenging. Success requires bridging the gap between technology and humanity, while finding the balance between the freedom to innovate, and the process of regulation. With technologies evolving at an exponential pace, healthcare companies must keep the user at the center of the development process. Over the years, we’ve helped our partners push the boundaries of healthcare, while staying grounded in humanity.

ISO 13485 Certified

Short on Resources, and Need a
Partner Who 'Gets It?' We're Ready.

Medical device development can be a tedious process, but being responsive, flexible, and attentive helps move projects along smoothly. We’ve helped projects spanning from initial research and human factors, to design and engineering, to verification and validation. Achieving ISO 13485 certification means our team understands the challenges of medical device development. We can run programs under our quality system, or operate effectively within yours. Over the years we’ve worked on a wide variety of products in the medical space:

  • Drug delivery devices
  • Robotic surgery systems
  • Soft robotics
  • DNA testing systems
  • Cardiac therapy systems
  • Laproscopic hand tools
  • Surgical headlamps
  • Wound therapy devices
  • Safe patient handling
  • Concussion mitigation devices
  • Inclusive physical therapy fitness equipment
  • Medical PPE
  • Medical gloves and gowns
  • Hospital pharmacy systems
  • Enteral feeding pumps
  • Defibrillators
  • Neuro surgery systems
  • Electrosurgical systems

"

There's no question that working with PD helped maked this product a success. There were many short-cuts we could've taken, but the PD team helped create a bigger vision.

Eric Miller

Director of Product Management, Werner

"

Priority Designs' overall breadth of experience is an invaluable resource. They've already learned what to do, or not what to do, and we've been thrilled with the relationship.

John Roby

President & CEO, Sirchie

"

It was clear that Priority Design's in-house team could handle the mechanical, industrial design, and electrical work which was a strength over other firms.

Jodi Lee

Brand Director, Scotts Miracle-Gro Company

"

Having BIG ideas is one thing, having someone be able to execute them for you is another. Priority Designs not only brought it to life, they made it even bigger.

Adam Beach

Owner, MyGolfSpy

"

Our collaboration with Priority Designs was a resounding success. Their commitment to excellence throughout the project ensure timely delivery and a product that perfectly aligns with our mission.

Jim Alloway

CEO, Pilot Dogs

"

PD helped guide us through the re-branding process in a way that really got to the core of our DNA. Their work resonated with both our upper managment and our users alike.

Alan English

Senior Brand Manager, Proto Industrial Distribution at Stanley, Black & Decker

"

PD's deep understanding of our users and ability to translate findings into actionable items is a powerful combination that helps keep our teams aligned and new programs on track.

Mary Glennon

Global Marketing Insights Manager, Hollister

"

From concept to design to TMV to testing, PD has been a valuable part of our team and we could not have done this without them. It has been an absolute pleasure working with them.

Kristen Bunch

Senior Engineer, R&D, TIDI Products

"

The Priority Design's team mastered to understand our niche market and it's end-users quickly, which has led to definition and development of an intuitive UI/UX, which exceeded our expectations.

Steffen Baumann

Former Senior Product Manager, Midmark Corporation

"

Working together on this project was much more than reviewing sketches and concepts - it was truly a collaboration. That doesn't happen without great people, and PD has them.

Eric Miller

Director of Product Management, Werner

"

PD has been exceptional to work with. Their in-depth understanding and partnership throughout the project far exceeded our expectations. We couldn't have done this without them.

Jenna Merandi

Medication Safety Officer, Nationwide Children's Hospital

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Medical Device Development

Our Specialties

Partnering through full-service development, or jumping in just where you need us.

Medical Device Human Factors & Usability

Throughout development, our human factors experts deliver evaluative data in the form of formative and summative usability testing to align with FDA expectations. Our methodologies not only evaluate usability from a safety and risk perspective, but as part of the total medical device user experience.

Learn More About Human Factors and Usability >

Medical Device User Experience Design

As interfaces move from physical to digital, our UX + UI experts work hand in hand with the human factors team to develop interfaces that limit the potential for user error, while delighting the user. Our cross-functional team understands medical device user experience design must comply with usability standards to ensure safety and efficacy for the patient and the caregiver. Navigating these waters can be challenging, as medical devices face a level of scrutiny that other interfaces may not. We incorporate risk assessments, formative and summative human factors evaluations, and our software engineers can partner with your systems engineering team to define and document interfaces to facilitate your 510k submission.

Learn More About Medical Device User Experience Design >

Medical Product Engineering

Our engineers bring a regimented, pragmatic approach to device development. We understand the engineering rigor, regulatory and clinical constraints and strive to deliver the best solution while meeting the requirements.

Our engineers work closely with manufacturing vendors at the early stages of development and perform DFX to ensure that our solutions  are manufacturable and meet cost targets. We utilize linear and non-linear finite element analysis (FEA), hand calculations, tolerance stack-ups and engineering fundamentals to achieve sound, effective designs. We can work autonomously, or as an extension of your team to get your product to production.

Our engineering team includes specialists within:

  • Mechanical Engineering
  • Systems Engineering
  • Electrical Engineering
  • Software Engineering
  • Biomedical Engineering

Medical Product Design

Our team of industrial designers explore opportunities, visualize meaningful experiences, and evaluate concepts with 2D and 3D design to help you translate healthcare insights to innovative product solutions. We utilize a human centered design process to create solutions that are not only safe and effective to use, but deliver the optimal user experience with your brand.

Medical Device Prototyping

Medical device prototypes incorporate engineering, design, and human factors input into a working prototype that brings your design to life. These prototypes can be used to inform your development activities, and refine your design throughout the development process.

With 10+ in-house prototyping specialists, a 15,000 sq. ft. shop and machines ranging from 3D printing to casting to CNC machining, our team specializes in iterative, high-quality prototyping. Our experts can be utilized at any point in the development process, from early proof-of-concept models to late stage fully-functional prototypes that bridge the gap to production. For the unique challenges of hard good components for medical wearables, our prototyping experts collaborate with our soft goods designers to expedite development.

Medical Packaging and IFU Design

In some cases, manufacturers are only able to rely on Instructions for Use (IFU) to communicate the safe and effective use of a medical product. Our team of visual designers, packaging designers and human factors experts collaborate to develop IFU’s, Quick Reference Guides (QRG), and packaging that minimizes risk and maximizes usability.

Regulatory Support Services

Our strategic partnership with CMD:Medtech combines Priority Designs’ development experts with CMD’s RAC certified regulatory experts, as well as their software, systems and regulatory expertise. This partnership enables us to offer a turnkey development solution.

Medical Device Development

Our Specialties

Partnering through full-service development, or jumping in just where you need us.

Medical Device Human Factors & Usability

Throughout development, our human factors experts deliver evaluative data in the form of formative and summative usability testing to align with FDA expectations. Our methodologies not only evaluate usability from a safety and risk perspective, but as part of the total medical device user experience.

Learn More About Human Factors and Usability >

Medical Device User Experience Design

As interfaces move from physical to digital, our UX + UI experts work hand in hand with the human factors team to develop interfaces that limit the potential for user error, while delighting the user. Our cross-functional team understands medical device user experience design must comply with usability standards to ensure safety and efficacy for the patient and the caregiver. Navigating these waters can be challenging, as medical devices face a level of scrutiny that other interfaces may not. We incorporate risk assessments, formative and summative human factors evaluations, and our software engineers can partner with your systems engineering team to define and document interfaces to facilitate your 510k submission.

Learn More About Medical Device User Experience Design >

Medical Product Engineering

Our engineers bring a regimented, pragmatic approach to device development. We understand the engineering rigor, regulatory and clinical constraints and strive to deliver the best solution while meeting the requirements.

Our engineers work closely with manufacturing vendors at the early stages of development and perform DFX to ensure that our solutions  are manufacturable and meet cost targets. We utilize linear and non-linear finite element analysis (FEA), hand calculations, tolerance stack-ups and engineering fundamentals to achieve sound, effective designs. We can work autonomously, or as an extension of your team to get your product to production.

Our engineering team includes specialists within:

  • Mechanical Engineering
  • Systems Engineering
  • Electrical Engineering
  • Software Engineering
  • Biomedical Engineering

Medical Product Design

Our team of industrial designers explore opportunities, visualize meaningful experiences, and evaluate concepts with 2D and 3D design to help you translate healthcare insights to innovative product solutions. We utilize a human centered design process to create solutions that are not only safe and effective to use, but deliver the optimal user experience with your brand.

Medical Device Prototyping

Medical device prototypes incorporate engineering, design, and human factors input into a working prototype that brings your design to life. These prototypes can be used to inform your development activities, and refine your design throughout the development process.

With 10+ in-house prototyping specialists, a 15,000 sq. ft. shop and machines ranging from 3D printing to casting to CNC machining, our team specializes in iterative, high-quality prototyping. Our experts can be utilized at any point in the development process, from early proof-of-concept models to late stage fully-functional prototypes that bridge the gap to production. For the unique challenges of hard good components for medical wearables, our prototyping experts collaborate with our soft goods designers to expedite development.

Medical Packaging & IFU Design

In some cases, manufacturers are only able to rely on Instructions for Use (IFU) to communicate the safe and effective use of a medical product. Our team of visual designers, packaging designers and human factors experts collaborate to develop IFU’s, Quick Reference Guides (QRG), and packaging that minimizes risk and maximizes usability.

Regulatory Support Services

Our strategic partnership with CMD:Medtech combines Priority Designs’ development experts with CMD’s RAC certified regulatory experts, as well as their software, systems and regulatory expertise. This partnership enables us to offer a turnkey development solution.

Other Healthcare Specialties

UX Medical Design

Learn More

Wearables

Learn More