A medical device design agency is a professional service organization that specializes in the design and development of medical devices and healthcare technology. These agencies offer a range of services, including product design, engineering, prototyping, and regulatory support, to help clients bring their medical device ideas to market.

Medical device design agencies work with a wide range of clients, including medical device manufacturers, healthcare providers, and research institutions, to develop innovative medical devices that improve patient outcomes and advance the field of healthcare. The medical device design process typically involves collaboration between the agency and the client, with the aim of creating a device that is safe, effective, and user-friendly.

A medical device design agency provides valuable support and expertise to help clients navigate the complex and highly-regulated medical device development process. With a deep understanding of the needs of patients, healthcare providers, and regulatory agencies, a medical device design agency is a critical partner for organizations looking to bring innovative medical devices to market and improve patient care.

We’ve developed and designed over a hundred of the most successful medical products on the market. Everything we do is centered around human-centered design principles that increase the quality of care of patient outcomes. The quality of a medical device is measured in a variety of metrics that include durability, accessibility, usability, and adaptability. We use processes to enhance all of these metrics to improve the quality of medical devices whether we are designing them and developing them, or whether we are simply refining an existing design. At RKS design and engineering work synergistically, ensuring that design decisions are made in consideration of engineering constraints and vice-versa. This unique communication ability, driven by our in-house design and engineering capabilities. When it comes to medical devices we understand adherence and usability are key factors to success in receiving FDA approval and in the market. The RKS team has experience supporting and leading teams through formative and summative testing to evaluate, optimize, and enhance product offerings during the iterative design phases. Additionally, RKS has worked with teams to support clinical testing and validation of systems to prepare for approvals and market launch.

The medical device design process can begin with ideation on one extreme or on execution on the other. Medical devices at the ideation stage will often include a research, synthesis, design, and execution phases. In the research phase, we will use our human-centered methodology, Psycho-Aesthetics to understand who we are designing for and where the market has shown a need for a new device. By identifying this opportunity zone through research synthesis, we can base future design on key qualitative and quantitative indicators. The design process is often iterative and includes human-factors testing with prototypes. Once the design or designs are finalized, we can help clients develop the new IP if there is any, and source and manage contract manufacturers for initial production.

Prototyping is an indispensable part of the design and development of medical devices. Now, more than ever medical devices are being designed using consumer product principles. Users and buyers of these products are empowered to make decisions on whether to use devices, and will make these decisions on how a product looks and feels. Prototyping is the best way to uncover how future users and buyers will respond to a product before the design is finalized. By testing these human factors with prototypes, we can receive real-time responses and reactions to potential design directions. RKS has a full prototyping lab in-house, that includes CNC machining, 3D printing, and AR/VR capabilities. RKS has the ability to support prototyping needs at all levels to facilitate the development process. Oftentimes our team is engaged early to create fast-fail feasibility prototypes and proof of concept prototypes to develop and test new features and functionality. This is typically where innovation and patent creation takes place and is instrumental in the development process. RKS also develops ergonomic and usability prototypes to support testing with users to validate approaches. The team also has the ability to create looks-like, works-like prototypes of systems for final validation and testing and can also support the creation of dozens of prototypes if needed prior to moving to a manufacturing partner for full product launch.

Ethnography is a holistic approach to research, meaning that it takes into account the entire context and culture of the community being studied. It looks at the various social and cultural factors that influence the behavior and practices of the people within that community. This includes factors such as language, religion, customs, traditions, and social norms.

One of the key strengths of ethnography is that it allows the researcher to gain a deep and nuanced understanding of the culture and community being studied. By living among the people and participating in their daily activities, the researcher is able to gain a rich and detailed understanding of their culture and practices. This level of immersion allows the researcher to capture the nuances and complexities of the culture that may be missed by more traditional research methods.

Ethnography is also a flexible and adaptable research method. As the researcher becomes a part of the community, they are able to adapt and modify their research approach based on the needs and interests of the community. This means that the research can evolve and change as the community changes, allowing for a more dynamic and responsive research process.
Ethnography is not without its limitations, however. One challenge is that the researcher may become too embedded in the community and lose objectivity. It is important for the researcher to maintain a critical and reflective approach to their research, and to be aware of their own biases and assumptions.

Another challenge is that ethnography can be time-consuming and resource-intensive. Because it involves in-depth, observational research, it can take longer to conduct than other research methods. Additionally, the researcher must invest a significant amount of time and effort into building trust and relationships within the community, which can be challenging.

Despite these challenges, ethnography remains an important and valuable method of qualitative research. It allows researchers to gain a deep and nuanced understanding of the cultures and communities they study, and to uncover the complex social and cultural factors that influence their behavior and practices.

ISO standards are voluntary, international, quality assurance certifications for processes, service, and documentation. There are three main ISO standards for medical device: ISO 13485, ISO/TR 20416, and ISO 20417. ISO 13485 is a quality management system and regulatory standard to ensure that medical device meet customer needs and regulatory requirements. ISO/TR 20416 is a surveillance process standard for collection and synthesis of data after a medical is manufactured. ISO 20417 is a standard for the information supplied by the manufacturer for a medical device. RKS works with all three standards during the design and development of a medical device. Typically, RKS will work with internal regulatory personnel within our clients team or a third party outside agency that specializes in managing the FDA approval process. RKS adheres to these ISO standards and works within the framework as defined by these teams. Given our extensive history working in the medical device space, RKS has partners who we can introduce you to that support compliance with FDA and ISO requirements.

Good product design for a medical device will make it safer, more reliable, and more likely to be adopted into a commercial success. Design for medical devices is now table-stakes, and there is no supplement or quick fix for a rigorous design process. Medical devices are often designed and developed years before they are commercially produced, and taking the time up-front to design medical devices for their users and systems will make them perform better over the long-run. Often, medical devices work within a complex system of processes and products. Designing around these processes and products can make a medical device easier to integrate, while increasing the standard of patient care and positive outcomes associated with proper care.

RKS is a full-service design and development firm, and we provide materials sourcing, manufacturing support, and product management as part of our key service offerings. RKS’ level of involvement in the manufacturing process varies and is typically controlled by the needs of our clients. Many times RKS is engaged to manage the transition to manufacturing which includes identifying, evaluating, and negotiating with potential manufacturing partners. From there, RKS will manage the tooling process, part evaluation, debugging, and all critical steps to get to product launch. RKS can also play a support role for clients who want to manage the process or has internal manufacturing capabilities as needed by the client team.

Medical device design is the process of creating innovative and safe devices that are used to diagnose, treat, or prevent medical conditions. Medical devices can range from simple devices such as thermometers and blood pressure monitors to complex devices such as pacemakers and MRI machines.

The process of medical device design involves several stages, including research, prototyping, testing, and production. During the research phase, designers work closely with medical professionals to understand their needs and identify areas where new devices could be beneficial. This information is used to develop prototypes, which are then tested rigorously to ensure their safety and effectiveness.

The goal of medical device design is to create devices that are safe, effective, and user-friendly. Medical devices must meet strict regulatory requirements to ensure their safety and efficacy, and designers must take into account factors such as ergonomics, usability, and patient comfort when developing new devices.