Medical Device Design and Engineering
RKS is a top medical device design and engineering firm that focuses on medical product design, engineering, development, and experience design.
RKS is a top medical device design and engineering firm that focuses on medical product design, engineering, development, and experience design.
Medical Device Services Overview
About US
As a top medical device design and engineering firm, we work with startups and well-established organizations to design and develop medical devices and products.
We have assisted our clients in creating new medical devices and re-imagining existing ones. Whichever stage of the product life cycle our clients approach us, we assist at all stages. We use our human-centered design thinking process to solve our client’s complex problems. Our solutions address medical device design, human-factors, product engineering, manufacturing, and regulatory issues.
Explore the services behind our Medical Device Work
Medical Device Design
Over the years, we have developed and implemented design, engineering, and development work in a diverse set of medical devices. We have created drug delivery systems, handheld surgical devices, mobile ventilators, and various other innovative medical devices.
We offer services in research, product design, human-factors industrial design, engineering, development, and experience design. Designing medical devices involves the creation and development of various types of products. We specialize in designing medical devices that diagnose, treat, and monitor all sorts of medical conditions. We create simple and complex systems that play a crucial role in improving healthcare outcomes and patient well-being.
Design and Research Capabilities
Human Factors for Medical Devices
Medical Device Industrial Design
Medical Device Technology Design
Medical Device Research
Medical Device Service Design
Medical Device Systems Design
Medical Device UI/UX
Human Factors for Medical Devices
Human factors design in medical devices enhances safety and usability by reducing user error and improving patient outcomes. It streamlines regulatory approval by meeting FDA and ISO standards, which prioritize user-centered safety protocols. By integrating risk management, it ensures compliance with regulatory requirements and prevents costly redesigns or recalls. Additionally, devices designed with human factors principles are more competitive in the market due to superior usability. This user-friendly approach increases patient acceptance and adherence, which contributes to the overall success of the product.
Medical Device Industrial Design
Industrial design enhances medical devices by making them user-friendly, comfortable, and safe, focusing on the needs of healthcare professionals and patients alike. RKS industrial designers optimize ergonomics, intuitive interfaces, and material durability, ensuring devices are easy to use, clean, and withstand frequent handling.
Medical Technology for Medical Device Development
Designing medical technology for medical device development is a complex and highly regulated process. Our design process starts with understanding the needs of the end-users, which includes healthcare professionals, patients, caregivers, and other stakeholders. We implement human-factors medical device engineering practices, focusing on optimizing the interaction between users and the devices. We create and test prototypes allowing our designers to test the functionality and usability of the device before final production.
Medical Device Research
Ethnographic research is the cornerstone of Psycho-Aesthetics, our advanced design-thinking methodology. Ethnographic research for medical devices involves observing surgeons, healthcare consumers, and patients in real-life situations. We conduct research in our subject’s real-life environment through clinical trials, verification tests, and medical product experience design.
Medical Services and Systems Design
To create and optimize the delivery of healthcare services, we design efficient, effective, patient-centered medical services and medical systems. Designing medical services and systems is an ongoing process that requires collaboration among healthcare professionals, administrators, policymakers, patients, and other stakeholders.
Product Engineering and Development
As a medical product engineering and development company, we prioritize functional design. Functional design emphasizes intuitive creativity and calculated scientific decision-making.
We’re committed to creating impactful products and medical devices that define their markets and industries and create new intellectual property. Our highly collaborative environment allows our designers to find best-in-class solutions. Our designers consider and define product form and function, usability, physical ergonomics, marketing, brand development, sustainability, and sales.
Engineering and Development Capabilities
Mechanical Engineering
Software Engineering
Electrical Engineering
Medical Device Intellectual Property Support
Medical Device Usability Testing & Engineering
Medical Device Manufacturing
Mechanical Engineering for Medical Devices
Mechanical engineering is essential for medical devices because it ensures they function reliably, safely, and effectively under various conditions. Mechanical engineers design precise components, mechanisms, and materials to handle stress, wear, and sterilization, all of which are critical for device durability and performance. Additionally, they work on prototyping, testing, and refining devices to meet regulatory standards, making sure each product is suitable for healthcare environments and patient use.
Software Engineering for Medical Products
Software engineering is crucial for medical devices because it enables advanced functionalities, data processing, and user interfaces that enhance diagnostic accuracy and treatment efficiency. Software engineers develop the algorithms, embedded systems, and user interfaces that allow medical devices to monitor, analyze, and respond to patient data in real-time, often integrating with other healthcare systems. Our team has extensive experience with cybersecurity, ensuring that sensitive patient information is protected, and regulatory compliance, meeting standards like FDA or CE requirements for software reliability and safety in medical environments.
Electrical Engineering for Medical Products
Electrical engineering is vital for medical devices as it provides the circuitry, power systems, and sensors that allow these devices to operate, capture data, and interact with their environment. Electrical engineers design and integrate components like microcontrollers, signal processors, and battery systems, ensuring that devices are both energy-efficient and reliable for prolonged medical use. Our team has extensive experience minimizing electromagnetic interference and maintaining signal integrity, which is essential for accurate readings and safe operation in the highly regulated healthcare field.
Proof of Concept
Our proof of concept method (POC) enables our team to provide a tangible concept to our client. By its nature, a proof of concept is a small exercise to test the design idea, an assumption, or a technology. The main purpose of developing a POC is to demonstrate the basic functionality of our design.
Beta Prototyping
Beta Prototyping is a quick and effective way of bringing a proof of concept to life. It allows potential users to evaluate, test and share their feedback. We can utilize this feedback to make improvements to the design and functionality of the product. Internally we use medical product prototyping to help our team create more accurate estimates of project completion.
Medical Product Compliance and Testing
A medical device has more compliance requirements than most products. Often these requirements create minimum specifications for the form and function of a new medical product. We use our expertise and experience to find the best solutions for each compliance requirement.
Medical Device Intellectual Property Support
Patenting new medical device technology is critical in creating lasting value for our clients. We identify the technology to patent early on in the design process. We also assist our clients in filing for patents.
We routinely assist attorneys and agents with the technical muscle to support the patent applications of our clients. Our experts help patent professionals draft effective and comprehensive claims based on the invention and the characterization data.
Medical Device Manufacturing
Design for Manufacturing is a holistic design and engineering process that begins with design and ends with manufacturing.
Our sourcing and vetting management services include finding the right manufacturing partner and managing the production of the final product. Our team engages our manufacturing partners throughout the process to ensure the early decisions are consistent with manufacturing needs.
Medical Device Usability Testing & Engineering
Medical device designers need to test their products with users to make sure they can use them easily. We gather feedback from users by testing prototypes of the product. We consider this medical product verification and it helps us ensure a products success. Additionally, we can identify any potential problems that may arise when using the product.
Development and Prototyping
Our advanced development and prototyping processes combine design, engineering, UI/UX to meet the needs of the brand and stakeholders experiences.
Medical device user experience must often comply with regulatory guidance while providing an excellent UX and UI aligned with forward-thinking brands. Throughout the design and engineering process, we apply usability testing, formative testing, human factors validation testing, and risk management.
Development and Prototyping Capabilities
Medical Device Prototyping
Medical Device Brand
Medical Device Digital Development
Medical Device Software Development
Medical Device Proof of Concept
Medical Device Beta Prototyping
Medical Product Compliance and Testing
Medical Device UX Design
Clinical-grade medical devices must meet a high standard in their performance, accuracy, and usability. We consider the UX of our medical devices at each step of the development process. We consider all aspects of the product, from it’s physical dimensions technical limitations. We learn to understand and care about everyone involved in making a medical device, not just the person who uses it.
Medical Device UI Design
User interfaces are the primary product touchpoints for most devices. Medical devices in particular rely on the simplicity and efficiency of their UIs. We consider a devices UI during all parts of our process. This is to ensure stakeholders understand and utilize the new devices in their most effective and safe manner.
Medical Device Brand Design
A brand defines the emotional connection between the user and the product. For new medical devices, it is essential to have a memorable identity. We create products with memorable identities by going beyond the basic psychological motivations of users. We generate emotional connections with the brand and the device itself.
Medical Device Digital Development
New medical devices blend software and hardware into a unified solution. RKS has expertise in developing solutions around the latest technologies.
Medical Device Software Development
Software is increasingly the most important touchpoint of a medical device. However, the medical device industry has not historically focused on software. For each medical device software design project, we consider the implication of software needs.
We have the capability to define and develop the necessary software in-house. Our software development capabilities for medical devices put us in a unique category among top medical device product design firms.
FAQ's
What does a medical device design firm do?
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.
What is our medical device development process?
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.
What is the medical device design process?
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.
Do you need to develop a prototype for medical device design & development?
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.
What is the ISO standard for medical devices?
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.
How does good product design improve performance of medical devices?
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.
Do our services include project management and manufacturing of the medical devices?
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.
What is medical device design?
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.
