Founded as Designs for Medicine in 1970, we are deeply rooted in user-centered medical product design.
Over forty-plus years we’ve developed hundreds of medical products — including surgical instruments, drug delivery devices, home health and rehabilitation devices, and complex medical diagnostic systems — that are safe, effective, innovative, and successful in the marketplace. They’re used by everyone from healthcare professionals to patients to lay caregivers.
Whether we’re developing new products or improving existing ones, our cross-disciplinary project teams of human factors and usability specialists, researchers, designers, and engineers tap into their experience with multiple industries and technologies to spark cross-pollination. This is especially important as medical devices continue to look and act more like consumer products.
Healthcare professionals’ expectations for usability are growing, and more lay caregivers and patients are administering their own treatments and medications. We nimbly bridge this narrowing gap between the consumer and medical sectors throughout every development phase: Product Design and Definition, User Research and Human Factors, and Engineering Development and Verification.
We assist from concept to launch — evaluating user requirements, studying competitive patents, finding patent opportunities, handling regulatory compliance issues, selecting approved materials and processes for manufacturing, processing documentation for FDA submissions, and designing the Product Brand Language. Cross-disciplinary project teams pull from our five in-house disciplines: user research, industrial design, interaction design, mechanical engineering, and electrical engineering. Our consumer and commercial work enhances our larger understanding of user needs, materials, and processes, along with design trends and emerging technology.
With more products featuring digital interfaces, design doesn’t end with the physical product. Our interaction designers and electrical engineers are often part of the project team. Their contributions may include user interface architecture and visual design for embedded touchscreens as well as the underlying electronics hardware and firmware. The development of mobile apps as companions to medical devices often comes into play. (Learn more about our integrated Digital-Physical Design expertise.)
Our portfolio of new-to-the-world and next-generation products includes:
Human factors and usability engineering are FDA-required components of any medical device design process and are crucial in determining the safety and effectiveness implications of design decisions. We assist clients throughout the human factors-related process of submitting to regulatory groups and institutional review boards (IRBs). We have extensive experience with regulatory compliance and are well-versed in standards requirements, including validation testing, CE marking (Europe), 510(k) submission (US), FDA guidelines (US), and Medical Devices Directive 93/42 EEC (Europe).
Ethnographic Research. Products for which development is informed by user research are safer, make fewer cognitive and physical demands on users, and are easier to learn and simpler to use. More and more companies are realizing the potential return on investment of early integration of user experience design and human factors into their product development process. Our Design Research expertise encompasses the tools and research methods that allow us to consider many different types of medical devices, users, tasks, and environments when we’re conducting generative and evaluative research.
We routinely go into the field to observe surgeons, healthcare consumers, patients, and other users in a broad range of contexts from homes to hospitals – and in U.S. to overseas markets.
Our researchers identify design opportunities informed by these real-world conditions. When we can’t be there, we use current and emerging technology to gather and analyze data. Go to Design Research to read more about our generative research methods (ethnography and observation, interviews, benchmarking, and competitive analyses) and evaluative research methods (human factors evaluation; simulated use; and comparative testing).
Formative and Summative Testing. Formative studies are designed to get representative users interacting with functional prototypes. Our human factors engineers run the users through realistic tasks and scenarios with devices, and we iterate as necessary as testing reveals the need for significant improvements.
The summative phase begins after final changes have been made to the design, and the device is production-ready. Summative testing for the FDA, also called Human Factors Validation Testing or Simulated Use Validation Testing, involves testing the device with a a minimum of 15 participants in each targeted user group in an actual use environment or simulation lab. We do both on- and off-site user testing.
Medical devices deliver some of our toughest development challenges. Our robust team of mechanical and electrical engineers use advanced tools to design medical products with complex mechanical and electromechanical systems. Our highly experienced and skilled team of degreed engineers is equally proficient leveraging hand calculations as they are the most advanced CAD-based analysis tools. These help us identify and solve for issues in the early stages of the design process — and shave precious time off of project schedules.
Prototyping and Testing. As described in Engineering Analysis and Optimization, we build and test prototypes to put all design options through their paces both virtually and physically. We’re frequently developing proof of principal models and building subsystems to remove risk from the process. With the tools in our engineering lab, we have the ability to simulate, test, and optimize for many factors.
Ultimately, our engineers will conduct failure mode and effects analysis (FMEA) with advanced CAD tools to determine design performance. This rigorous testing proves that each medical product meets the safety standards put in place by various governing bodies, such as the FDA, CSA, CE, and UL.
Getting To Production Ready. We work in parallel with client and production partners to make sure everything is ready to roll into efficient production. This process consists of: material and processes specification, vendor selection, detailed part design, software fine-tuning and testing, failure mode analysis, tolerance analysis, additional expert reviews to ensure compliance and effective manufacturing, and building and testing a beta prototype.
Though we’re capable of managing production, more typically we act as a consultant to the process and address opportunities for improvements as they arise.