Medical Device Development

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.

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

With over 30 years of product development experience, Priority Designs helps medical clients where they need it most: keeping development pipelines moving, delivering elevated user experiences, achieving usability goals, and ultimately transitioning relevant solutions to manufacturing.

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’re 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

HEALTHCARE WEARABLES

Medical wearables are positioned to revolutionize the way healthcare is delivered. A key element to their success is the hardware to human interface. Many of these devices require intimate contact to the user in order to function, and fit and comfort can make or break a product’s compliance. Our team understands sizing for user populations, considers textile selection for bio-compatibility, optimizes construction methods to reduce rough edges, and develops prototypes for on body usability and wear testing.

Priority Designs’ diverse team of garment designers, human factors experts, sourcing specialists and soft goods engineers collaborate to develop medical wearables that fit users comfortably while meeting the needs of the technology.

HEALTHCARE WEARABLES

Medical wearables are positioned to revolutionize the way healthcare is delivered. A key element to their success is the hardware to human interface. Many of these devices require intimate contact to the user in order to function, and fit and comfort can make or break a product’s compliance. Our team understands sizing for user populations, considers textile selection for bio-compatibility, optimizes construction methods to reduce rough edges, and develops prototypes for on body usability and wear testing.

Priority Designs’ diverse team of garment designers, human factors experts, sourcing specialists and soft goods engineers collaborate to develop medical wearables that fit users comfortably while meeting the needs of the technology.

Partnering Through Full-Service Development, Or Jumping In Just Where You Need Us

MEDICAL DEVICE RESEARCH

MEDICAL PRODUCT DESIGN

MEDICAL DEVICE USER EXPERIENCE DESIGN

MEDICAL PRODUCT ENGINEERING

MEDICAL DEVICE PROTOTYPING

MEDICAL DEVICE LABELING

REGULATORY SUPPORT SERVICES

MEDICAL DEVICE RESEARCH

Our medical device research methods provide valuable insights at any stage of the human-centered product development cycle. Leveraging our human factors expertise, our team has the unique skills to inform new product design using a balance of generative research methods and contextual inquiry to define the ideal product experience, user personas and task flows. We develop a deep understanding of your users and define opportunities to meet their unique needs. Our development team then take these insights and develop innovative solutions to evaluate with those same users.

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.

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 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.

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 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.

Meet the Team

The combination of our people’s unique skillsets is what makes Priority Designs unique. Our diverse experience helps us look at problems from every angle. Meet a few of our talented staff who support medical device development projects.

priority_designs_reade_harpham_2

Reade Harpham

SR. MEDICAL DEVICE SPECIALIST

Reade has spent 25 years focused on bringing a human centric approach to medical device development, with the ultimate goal of assuring new technologies live up to their potential.

priority_designs_craig_morin_2

Craig Morin

SR. ELECTRICAL/BIOMEDICAL ENGINEER

Craig brings a combined background in biomedical, software, and electrical engineering to approach medical device design from the perspective of multiple disciplines. His work spans 10 years of experience integrating sensors and systems to measure physiology and electrophysiology.

priority_designs_jeff_burger_2

Jeff Burger

SR. INDUSTRIAL DESIGNER

Jeff has over 15 years of experience in human-centered user experience design (UXD) to improve ease-of-use, safety and comfort. His projects have ranged from robotic systems, to wearable tech, to surgical tools.

priority_designs_james_lua_2

James Lua

SR. UX DESIGNER, INDUSTRIAL + USER INTERFACE

James has 15+ years of experience developing a range of medical products from robotic surgery devices to a concussion mitigation device. He designs the entire user experience for clinicians and patients, ensuring harmony between the physical product and the digital user interface.

priority_designs_stephannie_gandelman

Stephannie Kia

SOFT GOODS DESIGNER

Stephannie has a degree is Fashion Design, bringing her knowledge of garment and apparel design to the world of medical wearables. Her work includes sourcing textiles, choosing construction methods, patterning for 3D knit products, and ensuring optimal product fit and comfort while meeting design requirements.

priority_designs_brent_burchfield_2

Brent Burchfield

SR. MECHANICAL ENGINEER

Brent has 17 years of experience in medical product development and manufacturing. His specialties include non-linear structural FEA, designing for a broad range of manufacturing processes, testing, and 3D CAD development. He helps ensure that the product meets the client’s needs from the beginning through production.

priority_designs_jamison_float_2

Jamison Float

SR. BIOMEDICAL ENGINEER

Jamison’s work focuses on products that interface with the human body. His 20 years of experience include full-scale development for wearable, diagnostic, surgical, and protective devices. While navigating clinical testing and FDA requirements, Jamison delivers products that are creative, user-centric, and made for reality.

priority_designs_colton_turner_2

Colton Turner

SR. HUMAN FACTORS SPECIALIST

Colton conducts research including formative evaluations and accompanying instruction for use (IFU) in accordance with FDA Human Factors Guidelines. He identifies use-related risks, designs studies to evaluate risks and proposed mitigations then translates findings into actionable recommendations to improve usability.

Med Dev Articles From Our Team

How Digital Knitting Can Stitch a Better Bottom Line on Medical Wearables

By Stephannie Kia, Soft Goods Designer
Read The Article

Composing Compliance: How Music Theory Can Meet Standards While Elevating Experience

By Eddie Gandelman, Sr. Product Designer
Read The Article

ISO 13485 Certified For Complete Medical Device Development

By Reade Harpham, Sr. Medical Device Specialist
Read The Article

LET'S GET STARTED ON YOUR PROJECT

Tell us about your product’s needs and start a conversation.