Ready to Start a Project?
To get started, tell us a little bit about the project you’re working on and how we can help. We’ll get an NDA in place if needed, and continue by understanding more of the details to put together a proposal. We’ll likely have a phone call to talk through your project, or when possible it’s great to have you in for an on-site meeting and to tour our facilities.
If you’d prefer to reach out to us by phone, you can call our office at 614-337-9979.
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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 13485:2016 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
“Working with Priority Designs produced critical insights in the usability and comprehension of a new design concept for medical staff apparel. Results gathered from users in a simulated environment were integrated into the final refinement stages of development, providing higher confidence in delivering a customer-centric product.”
“Our team originally selected Priority Designs for expertise in human factors and we continue to work with them due to their depth of understanding of our user groups, ability to translate findings into actionable items and the clarity of their recommendations. It’s a powerful combination that has helped keep our cross-functional team aligned and our new product programs on track.”
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
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.
Stephanie Kute
SENIOR PROJECT MANAGER
Stephanie uses her background in Biomedical Engineering and certification as a Project Management Professional to lead multi-disciplinary teams in the development of medical devices that meet the needs of the customer. Over the past 20+ years, she’s managed projects from the initial concept phase through manufacturing. From wearable diagnostic sensors to hand-held combination products to hospital-based blood analyzers, she helps teams successfully navigate technical and regulatory complexity, tight timelines and strict budgets.
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.
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.
Anne Marie Tollett
MECHANICAL AND BIOMEDICAL ENGINEER
Anne Marie has over 8 years of experience developing wearable, diagnostic, surgical, and protective devices, while navigating clinical testing and FDA requirements. Anne Marie delivers products that are creative and made for reality, while meeting the unique needs of the medical industry.
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.
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.
Nick Annetta
SR. ELECTRICAL ENGINEER
Nick has 15+ years of experience developing a variety of medical devices, from low-power wearables to large laboratory equipment. His technical background is in electronic hardware design for sensors, signal processing, and algorithm development, with a particular depth in neurotechnology.
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 13485:2016 Certified For Complete Medical Device Development
By Reade Harpham, Sr. Medical Device Specialist
Read The Article