Successful medical device design and development requires a multidisciplinary approach. Collaborating with a seasoned industrial design team — along with an experienced team of mechanical, electrical, and software engineers — will help to ensure your product’s safety and efficacy, as well as end-user satisfaction.
Balancing Safety, Efficacy, and End-User Satisfaction
Benchmark’s user-centered industrial design (ID) process seeks to ensure that your medical device will not only prove efficacious for humans but will also delight the end user in both form and function. But who are the end-users of a medical device? Is it the patients who may wear a device, have it applied to their body, or experience it as part of the clinical environment? Is it the technicians and nurses who operate the device or teach the patient how to use a home device? Or is it the doctor relying on the data to make a diagnosis? What about the administrators making medical device purchasing decisions? The answer is “all of the above.”
Balancing the potentially conflicting needs of these stakeholders can be challenging. For example, home-use devices need very straightforward buttons and controls that can be operated by the elderly and people with limited use of their extremities. However, this requirement can conflict with a doctor’s need to collect many types of data. A nurse or technician may require a lean, easy-to-hold device, but densifying the electronics in this way may add extra cost that an administrator may not appreciate.
To achieve an optimal balance, medical device development teams need to include industrial designers. These specialized development processes must include end-user feedback steps that are inclusive of all stakeholders. Collaboration with our experienced industrial designers — along with mechanical, electrical, and software engineers — will help to address your medical device’s aesthetic appeal while focusing squarely on safety, efficacy, and end-user satisfaction. This approach will increase the likelihood of your product’s success in the marketplace.
Industrial Design in Medical Device Development
One of the key responsibilities of our industrial design teams is to help our medical customers advance a product from concept through verification and provide support for validation efforts. This rigorous process enhances the safety and efficacy of the medical device, aligning it with the United States Food and Drug Administration (FDA) compliance and usability standards.
The FDA device usability standard as dictated by International Electrotechnical Commission (IEC) 60601-1-6 3rd Edition is arguably one of the most critical standards for medical device manufacturers and developers to meet. Regardless of a connected medical device’s class, developers and manufacturers must conduct formative and summative usability studies to ensure safety, reliability, and acceptable performance.
Formative Usability Testing
Formative usability testing should be ideally conducted throughout the device development phase. By either using a model, a virtual simulation, or a physical prototype, user representatives of all user groups perform the tasks that the medical device is intended to be used for while observers collect data. Often referred to as “verification testing,” formative usability testing aims to prove that the design meets the specifications as laid out in the product development specification (PDS) documentation. Verification testing involves reviewing design documents, as well as conducting inspections and performance “bench” testing (specialized testing to ensure the medical device is void of mechanical or design flaws).
Summative Usability Testing
Once the medical device has gone through the development phase and has passed all formative usability tests, summative usability testing is required as part of device validation. This is the final phase, evaluating whether the qualification build of the medical device meets all requirements.
Within busy healthcare facilities, some common interferences that a connected medical device must overcome include alarms, poor lighting, fluctuating temperatures, and interruptions. Therefore, summative usability testing must be performed in a real-world setting or within a real-operating environment to ensure that all factors — including function, performance, stress, load, capability, interoperability, and usability — withstand potential interferences.
After undergoing these rigorous summative usability tests, should the medical device prove to function correctly as intended while meeting all requirements, the product is considered ready to enter production. Although summative usability is owned by — and is ultimately the responsibility of — the customers, Benchmark is strategically positioned to provide support services.
The Benchmark Difference — A Complete Product Development Team
Many contract manufacturing partners are proficient in refining your medical device design and then transitioning that design into production. Although this process requires a high level of expertise, they don’t necessarily include innovation. That is where Benchmark comes in.
In both ID and user experience (UX) design, Benchmark follows a systematic and iterative process to ensure that our designs meet customer requirements. However, we always keep the end user’s experience front of mind. We employ a design-thinking approach to problem solving that involves empathizing with the end user, defining the problem, ideating potential solutions, prototyping, and testing. Based on the complexity and scope of a given project (as well as on the needs of our customers), our services can include some — or all — the activities associated with our ID and UX process as outlined below:
1. Design Research
At Benchmark, we understand that design research is a critical step in the product development process. As such, we conduct thorough research to gain a deep understanding of the market, user needs, and emerging trends. We use various research techniques, including interviews, focus groups, surveys, and observational studies to gather data and insights. Our designers analyze this data to identify pain points, opportunities, and design constraints. Part of the research process also involves analyzing the medical device for appearance, feasibility, functionality, manufacturability, and end-user experience.
2. User Studies
After conducting design research, we perform user studies to gain a better understanding of our target audience. We interact with users in various roles to identify their needs, preferences, and behaviors. This information is then used to develop user personas that help us create products that are tailored to each customer’s needs. Our user studies also help us identify usability issues and refine our designs to improve the end-user experience.
3. Concept Generation
In the concept generation stage, our designers use the insights gathered from research and user studies to generate ideas and concepts for the product. We use various techniques such as brainstorming, sketching, and storyboarding to explore different design solutions. We then develop multiple concepts and present them to our customers for feedback.
After completing the design concept, we move on to the prototyping stage. We use various prototyping techniques, including hand-sculpted foam mockups, 3D printing, computer numerical control (CNC) machining, and Urethane castings to create functional prototypes.
5. User Testing
We also conduct user testing to elicit feedback on the prototype and identify areas for improvement. These tests can include user surveys, use simulations, cognitive walk-throughs, and observational user-panel studies.
6. Design Refinement
Based on the feedback we receive from user testing, we might refine our design to further meet customer needs and improve the user experience. We iterate through the design process until we have a final design that meets all requirements.
When Your Medical Device Matters, Turn to Benchmark
Benchmark's in-house industrial design services differentiate us from our competitors and provide significant benefits to our customers. Our design team's expertise in research, user studies, design processes, concept generation, prototyping, and testing ensures that we create products that meet customer needs, preferences, and brand identity. Our industrial design services help our customers reduce time to market, lower costs, and improve the user experience, ultimately leading to business success and increased end-user satisfaction.
When your medical device matters, turn to Benchmark.