Medical Device Design

Medical Device Design

We identify meaningful opportunities for medical devices and shepherd ideas from concept to launch

RKS logo small

Medical Device Design and Development

Services

We identify meaningful opportunities and shepherd ideas from concept to launch

RKS logo small
RKS logo small

Medical Device Design Services

Prototyping for Medical Product Design and Development

About RKS

As a top medical device product design company and medical device development firm, we specialize in the design and engineering of medical devices. Whether creating new a medical device or re-imagining an existing one, our medical device company assists at all stages of the product life cycle. We use our unique human-centered design-thinking process to solve complex problems that address medical device design, product engineering, brand, and regulatory issues. Our development team can also assist with medical device manufacturing. Our cross-disciplinary specialists, researchers, designers, and engineers leverage their deep experience within multiple industries and technologies to spark creative and innovative solutions.

Over the years we have developed and implemented design, engineering, and development work in a diverse set of categories: drug device delivery, handheld surgical device, human factors and usability testing, intellectual property support, medical device development, mobile medical device, patient monitoring, rehabilitation device, consumer healthcare device, diagnostic device, and digital interface design. We offer services in research, product design, industrial design, engineering, development, and experience design. At a more granular level, we also provide services in product definition, technology roadmap development, future concept development, interface design, user research design, usability testing, engineering development and verification, design for CLIA certification, proof of concept prototyping, beta prototyping, ISO 13485 compliance, FDA compliance, and intellectual property support.

RKS logo small

Innovating better, together, since 1980.

About RKS

As a top medical device product design company and medical device development firm, we specialize in the design and engineering of medical devices. Whether creating new a medical device or re-imagining an existing one, our medical device company assists at all stages of the product life cycle. We use our unique human-centered design-thinking process to solve complex problems that address medical device design, product engineering, brand, and regulatory issues. Our development team can also assist with medical device manufacturing. Our cross-disciplinary specialists, researchers, designers, and engineers leverage their deep experience within multiple industries and technologies to spark creative and innovative solutions.

RKS logo small

Over the years we have developed and implemented design, engineering, and development work in a diverse set of categories: drug device delivery, handheld surgical device, human factors and usability testing, intellectual property support, medical device development, mobile medical device, patient monitoring, rehabilitation device, consumer healthcare device, diagnostic device, and digital interface design. We offer services in research, product design, industrial design, engineering, development, and experience design. At a more granular level, we also provide services in product definition, technology roadmap development, future concept development, interface design, user research design, usability testing, engineering development and verification, design for CLIA certification, proof of concept prototyping, beta prototyping, ISO 13485 compliance, FDA compliance, and intellectual property support.

Innovating better, together, since 1980.

Animated list of RKS award logos

Device Design

Psycho Aesthetics® (P/A) is our unique human-centered approach to design thinking. Among top medical device design companies and medical device engineering firms, we are able to create uniquely transformational experiences in healthcare. Over the decades we have spent developing and evolving P/A, it has continually progressed into a highly advanced design-thinking tool and process that allows designers to create a shared objective, pragmatic, and insightful approaches to product design, engineering, and development. We apply our methodology to all parts of the design and innovation process, from research, design, and engineering, to UX, branding, name development, mission and vision statements, interaction design, and more. It provides an open design framework under which the key understandings of our research and consumer insights are mapped onto a consistent framework.

P/A is a universal design tool and process that is only limited by individuals’ openness to working within frameworks and their own talents. Combined with “design doing,” success is exponentially advanced when created through this framework and process. P/A however is tool that drives business and healthcare results. Too often design is singularly about aesthetics. Our humanized design-thinking process P/A, is about driving emotional connection that meets users needs and business goals.

RKS Product Design Firm designed Hamilton T1 Mobile Ventilator

Medical Device Research Design

In most cases, designers are not the users of a medical device. Without deeper understanding and insights into user’ behavior and psychological patterns, RKS designs would be unable to create long and lasting benefits over many years. This foundation of this success comes from insights into people, their needs, their aspirations, their challenges, how they work, live and play, and the interior and social architecture of their lives. We use this picture as the basis of designs. Our team has years of experience designing, executing, and transferring data from our ethnographies to award-winning designs. Ultimately, products informed by user research are safer, easier to learn, and simpler to use.

Medical Device Product Design

Ethnographic research is a cornerstone of our advanced design-thinking methodology, psycho-aesthetics. Ethnographic research is a qualitative method where our researchers observe and interact with potential users in their real-life environment. 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 hobbies. When we can’t be there physically, we use current and emerging technology to gather and analyze data. In addition to ethnography and observation, we use interviews, benchmarking, and competitive analyses, as well as evaluative research methods such as human factors evaluation, simulated use, and comparative testing.

Ethnographic Research for Medical Devices

Determining a strategy for a medical device requires a holistic approach. We consider everything from our client’s priorities to financial investment to regulatory requirements. In other words, we are not just looking at the product, but the entire user experience with the product. We identify the essential product features and balance those against both product cost and project schedule to come up with a product that meets the users’ requirements at a price that they are willing to pay. Our designers serve as user advocates, examining all the elements of the user experience including everything from user manuals to product graphics, the user interface, and servicing issues. To make the most cost-effective products possible, we consider questions, such as what happens when this product is at the end of its life? What do you do with it, and how do you disassemble it? The industrial nature of medical product, the need for repeated high-velocity use puts unique demands on design and quality. This quality is not just about functionality and durability, but about how the product makes contact with the user, and empowers them.

Medical Device Design for Services and Systems

During the synthesis phase of the process, we transform our research into useful, actionable insights. Often this is when we create the P/A “War Room.” The War Room is an immersive environment that evokes higher levels of empathy and facilitates creative immersion sessions that combine the creative design team with other disciplines, from engineering to marketing to manufacturing and shipping. We begin with competitive mapping, where we translate our general understanding of the market to our P/A Map. At the same time, we translate our understanding of customers to personas and triggers. We then combine our competitive mapping with triggers and personas on the P/A Map, which gives us a qualitative understanding of the Opportunity Zone. The Opportunity Zone is where gaps in consumer emotions and desires are not met by current industry offerings and where improvements in the market can be made. With the opportunity zone mapped, our cross-functional team can now gain a visual understanding of where there is white space representing opportunity.

VGX Inovio DNA Vaccine dispenser on table
RKS Product Design Firm designed Inovio DNA Vaccine

Stakeholder Alignment

Once we synthesize our research, we can create insights that will make their way into the product. By identifying repeating patterns of desire in the personas, we are able to define what is most important to each individual. We call these patterns of desire Key Attractors, and we can turn them into considerations to motivate the product design. These Key Attractors will motivate us to choose specific design features, touchpoints, haptics, and emotional responses that engage particular target groups. They will continue to provide guidance throughout the design process and can be evaluated against competitive offerings to ensure the creation of unique products and services that successfully differentiate in the market.

Medical Technology for Medican Device Development

Once we synthesize our research, we can create insights that will make their way into the product. By identifying repeating patterns of desire in the personas, we are able to define what is most important to each individual. We call these patterns of desire Key Attractors, and we can turn them into considerations to motivate the product design. These Key Attractors will motivate us to choose specific design features, touchpoints, haptics, and emotional responses that engage particular target groups. They will continue to provide guidance throughout the design process and can be evaluated against competitive offerings to ensure the creation of unique products and services that successfully differentiate in the market.

Device Design

Psycho Aesthetics® (P/A) is our unique human-centered approach to design thinking. Among top medical device design companies and medical device engineering firms, we are able to create uniquely transformational experiences in healthcare. Over the decades we have spent developing and evolving P/A, it has continually progressed into a highly advanced design-thinking tool and process that allows designers to create a shared objective, pragmatic, and insightful approaches to product design, engineering, and development. We apply our methodology to all parts of the design and innovation process, from research, design, and engineering, to UX, branding, name development, mission and vision statements, interaction design, and more. It provides an open design framework under which the key understandings of our research and consumer insights are mapped onto a consistent framework.

P/A is a universal design tool and process that is only limited by individuals’ openness to working within frameworks and their own talents. Combined with “design doing,” success is exponentially advanced when created through this framework and process. P/A however is tool that drives business and healthcare results. Too often design is singularly about aesthetics. Our humanized design-thinking process P/A, is about driving emotional connection that meets users needs and business goals.

RKS Product Design Firm designed Hamilton T1 Mobile Ventilator
Medical Device Research Design

In most cases, designers are not the users of a medical device. Without deeper understanding and insights into user’ behavior and psychological patterns, RKS designs would be unable to create long and lasting benefits over many years. This foundation of this success comes from insights into people, their needs, their aspirations, their challenges, how they work, live and play, and the interior and social architecture of their lives. We use this picture as the basis of designs. Our team has years of experience designing, executing, and transferring data from our ethnographies to award-winning designs. Ultimately, products informed by user research are safer, easier to learn, and simpler to use.

Medical Device Product Design

Ethnographic research is a cornerstone of our advanced design-thinking methodology, psycho-aesthetics. Ethnographic research is a qualitative method where our researchers observe and interact with potential users in their real-life environment. 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 hobbies. When we can’t be there physically, we use current and emerging technology to gather and analyze data. In addition to ethnography and observation, we use interviews, benchmarking, and competitive analyses, as well as evaluative research methods such as human factors evaluation, simulated use, and comparative testing.

VGX Inovio DNA Vaccine dispenser on table
Ethnographic Research for Medical Devices

Determining a strategy for a medical device requires a holistic approach. We consider everything from our client’s priorities to financial investment to regulatory requirements. In other words, we are not just looking at the product, but the entire user experience with the product. We identify the essential product features and balance those against both product cost and project schedule to come up with a product that meets the users’ requirements at a price that they are willing to pay. Our designers serve as user advocates, examining all the elements of the user experience including everything from user manuals to product graphics, the user interface, and servicing issues. To make the most cost-effective products possible, we consider questions, such as what happens when this product is at the end of its life? What do you do with it, and how do you disassemble it? The industrial nature of medical product, the need for repeated high-velocity use puts unique demands on design and quality. This quality is not just about functionality and durability, but about how the product makes contact with the user, and empowers them.

Medical Device Design for Services and Systems

During the synthesis phase of the process, we transform our research into useful, actionable insights. Often this is when we create the P/A “War Room.” The War Room is an immersive environment that evokes higher levels of empathy and facilitates creative immersion sessions that combine the creative design team with other disciplines, from engineering to marketing to manufacturing and shipping. We begin with competitive mapping, where we translate our general understanding of the market to our P/A Map. At the same time, we translate our understanding of customers to personas and triggers. We then combine our competitive mapping with triggers and personas on the P/A Map, which gives us a qualitative understanding of the Opportunity Zone. The Opportunity Zone is where gaps in consumer emotions and desires are not met by current industry offerings and where improvements in the market can be made. With the opportunity zone mapped, our cross-functional team can now gain a visual understanding of where there is white space representing opportunity.

RKS Product Design Firm designed Inovio DNA Vaccine
Stakeholder Alignment

Once we synthesize our research, we can create insights that will make their way into the product. By identifying repeating patterns of desire in the personas, we are able to define what is most important to each individual. We call these patterns of desire Key Attractors, and we can turn them into considerations to motivate the product design. These Key Attractors will motivate us to choose specific design features, touchpoints, haptics, and emotional responses that engage particular target groups. They will continue to provide guidance throughout the design process and can be evaluated against competitive offerings to ensure the creation of unique products and services that successfully differentiate in the market.

Medical Technology for Medican Device Development

Once we synthesize our research, we can create insights that will make their way into the product. By identifying repeating patterns of desire in the personas, we are able to define what is most important to each individual. We call these patterns of desire Key Attractors, and we can turn them into considerations to motivate the product design. These Key Attractors will motivate us to choose specific design features, touchpoints, haptics, and emotional responses that engage particular target groups. They will continue to provide guidance throughout the design process and can be evaluated against competitive offerings to ensure the creation of unique products and services that successfully differentiate in the market.

Product Engineering and Development

As a medical device product development and engineering company we prioritize functional design that 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 that consider and define product form and function, usability, physical ergonomics, marketing, brand development, sustainability, and sales. Our design and engineering process has become game-changing for our clients, as medical devices continue to look and act more like consumer products.

Medical Device Design for Allergan Juvederm syringe with pink background

Medical Product Definition and Product Design

Our product definition and design process uses our unique psycho-aesthetic approach, which aims to create emotional connections between the device and users. Modern medical devices have increasing numbers of stakeholder users with different needs and budgetary constraints. To be successful, a modern medical device might have to be approved by a regional or national regulatory authority, selected by a healthcare provider, specified by a particular clinical team, and then chosen by doctors, often in consultation with patients. Finally, it may be the patient’s own reactions to the medical device that define its success. At the same time, expectations for product usability are growing, as more caregivers and patients are administering their own treatments and medications. When we design new medical products we consider all stakeholders in our product definition and product design.

Medical Engineering Development and Verification

Medical devices pose unique challenges that require deep engineering experience. Our design and engineering teams have years of experience creating medical devices that rely on complex mechanical and electromechanical systems with low tolerances. Using the latest in AR/VR and CAD-based tools, our team engineers identify and solve these complex issues early in the design process. This means that by the time a medical product goes through compliance and certification, including FDA certification, we’ve already prepared and addressed many of the issues that might come up.

Medical Device Technology Roadmap Development

The technology roadmap creates a framework for the development a medical technology. The roadmapping process is conducted in three phases: preliminary activities, the development of the roadmap, and follow-up activities. In the preliminary stage, we satisfy essential requirements, assign leadership, and define the scope and boundaries under the initial vision. In the second phase, the development phase we identify the critical system requirements, the major technology areas, the technology drivers and their targets, and the alternatives. In the final phase, we allow our roadmap to be critiqued and improved before implementation. This unique process assures that we focus on cost-advantageous technologies that deliver remarkable results for medical product and their ecosystems.

Proof of Concept

Our proof of concept method (POC) enables our team to share internal knowledge, explore emerging technologies on the technology roadmap, and 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 and to verify a certain concept or theory that can be achieved in development. Included in this can be a failure mode and effects analysis (FMEA) to ensure that the medical product meets the safety standards put in place by various governing bodies, such as the FDA, CSA, CE, and UL.

Perimetrics InnerView AI Exploded On Table
RKS Product Design Firm designed Amgen Aimovig

Beta Prototyping

Beta Prototyping is a quick and effective way of bringing a proof of concept to life and 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, beta prototyping helps our team create a more accurate estimate of how long it will take to complete a production model. Because our human-centered design process focuses on the user, prototyping is one of the most useful processes for moving forward into production, while quickly finding any issues.

Future Concept Development for Medical Devices

After designing a proof of concept and producing a prototype, we roadmap future features, technologies, and products. Future concept development engages the dynamic environment of global trends, and changing user needs. Future concept development can include simple requirements or additional proof of concepts and prototypes. This often depends on the needs of the client, and the specific type of device.

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. Fortunately, we can rely on our deep understanding of compliance issues and years of experience to find best-in-class solutions to each compliance requirement, such as FDA, CLIA Certification, ISO and 13485 Compliance, and European Medical Devices Regulation (MDR). We also help our clients navigate these issues as they come up with during the entire process.

Medical Device Intellectual Property Support

Patenting new medical device technology is critical in creating lasting value to our clients and to end users. We consider whether there is technology to patent early on in the design process, and work with our customers to file patents to the USPTO. 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. In addition to help with data, we help to provide clear technical support throughout the entire application and prosecution process. In the end, patents allow our customers to own outright the innovations we build together.

Amgen Aimovig Migraine Dispenser Render
Product design firm Talis Biomedical

Medical Device Manufacturing

Design for Manufacturing is holistic deign and engineering process that begins with design and ends with manufacturing. Choices made early on often have significant downstream effects in manufacturing. We’ve spent decades developing relationships with manufacturers all over the world. Our experience has also allowed us to source and vet new manufacturing partners when necessary reliably. 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 Engineering

Our 20,000 ft. design studio houses the latest in design and engineering equipment. We use our state-of-the art equipment to keep most of the prototyping and engineering processes in house, giving us greater control over the design and development process. At each stage of the development, we can holistically apply our expertise ensuring that the project is efficient and systematic. This results in better quality and control over the device and long-term decision-making. At times when use outside companies or partners to assist, these companies are leaders in their field, and vetted and trusted long-term partners.

Development and Engineering

As a medical device product development and engineering company we prioritize functional design that 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 that consider and define product form and function, usability, physical ergonomics, marketing, brand development, sustainability, and sales. Our design and engineering process has become game-changing for our clients, as medical devices continue to look and act more like consumer products.

Medical Device Design for Allergan Juvederm syringe with pink background
Medical Product Definition and Product Design

Our product definition and design process uses our unique psycho-aesthetic approach, which aims to create emotional connections between the device and users. Modern medical devices have increasing numbers of stakeholder users with different needs and budgetary constraints. To be successful, a modern medical device might have to be approved by a regional or national regulatory authority, selected by a healthcare provider, specified by a particular clinical team, and then chosen by doctors, often in consultation with patients. Finally, it may be the patient’s own reactions to the medical device that define its success. At the same time, expectations for product usability are growing, as more caregivers and patients are administering their own treatments and medications. When we design new medical products we consider all stakeholders in our product definition and product design.

Medical Engineering Development and Verification

Medical devices pose unique challenges that require deep engineering experience. Our design and engineering teams have years of experience creating medical devices that rely on complex mechanical and electromechanical systems with low tolerances. Using the latest in AR/VR and CAD-based tools, our team engineers identify and solve these complex issues early in the design process. This means that by the time a medical product goes through compliance and certification, including FDA certification, we’ve already prepared and addressed many of the issues that might come up.

Perimetrics InnerView AI Exploded On Table
Medical Device Technology Roadmap Development

The technology roadmap creates a framework for the development a medical technology. The roadmapping process is conducted in three phases: preliminary activities, the development of the roadmap, and follow-up activities. In the preliminary stage, we satisfy essential requirements, assign leadership, and define the scope and boundaries under the initial vision. In the second phase, the development phase we identify the critical system requirements, the major technology areas, the technology drivers and their targets, and the alternatives. In the final phase, we allow our roadmap to be critiqued and improved before implementation. This unique process assures that we focus on cost-advantageous technologies that deliver remarkable results for medical product and their ecosystems.

Proof of Concept

Our proof of concept method (POC) enables our team to share internal knowledge, explore emerging technologies on the technology roadmap, and 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 and to verify a certain concept or theory that can be achieved in development. Included in this can be a failure mode and effects analysis (FMEA) to ensure that the medical product meets the safety standards put in place by various governing bodies, such as the FDA, CSA, CE, and UL.

RKS Product Design Firm designed Amgen Aimovig
Beta Prototyping

Beta Prototyping is a quick and effective way of bringing a proof of concept to life and 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, beta prototyping helps our team create a more accurate estimate of how long it will take to complete a production model. Because our human-centered design process focuses on the user, prototyping is one of the most useful processes for moving forward into production, while quickly finding any issues.

Future Concept Development for Medical Devices

After designing a proof of concept and producing a prototype, we roadmap future features, technologies, and products. Future concept development engages the dynamic environment of global trends, and changing user needs. Future concept development can include simple requirements or additional proof of concepts and prototypes. This often depends on the needs of the client, and the specific type of device.

Amgen Aimovig Migraine Dispenser Render
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. Fortunately, we can rely on our deep understanding of compliance issues and years of experience to find best-in-class solutions to each compliance requirement, such as FDA, CLIA Certification, ISO and 13485 Compliance, and European Medical Devices Regulation (MDR). We also help our clients navigate these issues as they come up with during the entire process.

Medical Device Intellectual Property Support

Patenting new medical device technology is critical in creating lasting value to our clients and to end users. We consider whether there is technology to patent early on in the design process, and work with our customers to file patents to the USPTO. 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. In addition to help with data, we help to provide clear technical support throughout the entire application and prosecution process. In the end, patents allow our customers to own outright the innovations we build together.

Product design firm Talis Biomedical
Medical Device Manufacturing

Design for Manufacturing is holistic deign and engineering process that begins with design and ends with manufacturing. Choices made early on often have significant downstream effects in manufacturing. We’ve spent decades developing relationships with manufacturers all over the world. Our experience has also allowed us to source and vet new manufacturing partners when necessary reliably. 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 Engineering

Our 20,000 ft. design studio houses the latest in design and engineering equipment. We use our state-of-the art equipment to keep most of the prototyping and engineering processes in house, giving us greater control over the design and development process. At each stage of the development, we can holistically apply our expertise ensuring that the project is efficient and systematic. This results in better quality and control over the device and long-term decision-making. At times when use outside companies or partners to assist, these companies are leaders in their field, and vetted and trusted long-term partners.

Experience Design

The experience of a product is a combination of the UI, and UX, and branding of the experience. This experience must often comply with regulatory guidance, while providing an excellent UX and UI. During all stages of our medical product design and engineering process we apply usability testing, formative testing, human factors validation testing, and usability engineering for risk management. Due to their life-saving nature device experience must often comply with regulatory guidance and requirements, including: FDA Guidance 1757: Applying Human Factors and Usability Engineering to Medical Devices; AAMI/ANSI HE75:2009 Human Factors Engineering – Design of Medical Devices; AAMI/ANSI/IEC 62366-1:2015, CE marking (Europe); and Medical Devices Directive 93/42 EEC (Europe). We consider these requirements throughout our process.

Discus Dental Nuance Syringe design elements

Medical Device Usability Testing & Engineering

Medical device designers must conduct human factors validation testing to demonstrate that the intended users of a device can operate the product to perform the intended uses in the intended use environment. Otherwise known as usability engineering, the goal of these requirements are to ensure that the device has been optimized to eliminate, or reduce to the furthest extent possible errors that could cause harm to a patient. We conduct formative studies on product prototypes with representative users to answer design questions, identify strengths, probe for weaknesses, and detect potential errors that may occur while using a product. We also work with medical device manufacturers to craft our research around risk analyses that identify the risks associated with device utilization and the KPIs that have been chosen to reduce those risks.

Medical Device UX Design

Professional clinical-grade medical devices must be held to a high standard in their performance, accuracy, and usability. In order for those higher standards to be met, the UX of those medical devices must be considered from research, through design, development, and on to manufacturing. We consider all aspects of the product from it’s physical dimensions, technical limitations. at the outset, we’re trained to empathize not only with the end-user, but with the various parties involved with the development of a new medical device.

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. The wrong press of a button when using a computer may delete a document, but the wrong press of a button when administering medicine through an infusion pump, may be an overdose. As a result of these human-scale issues for medical devices, simplicity and efficiency are paramount. We consider the UI during all parts of our process, in order to make sure that all stakeholders can 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 product. Much of what a product makes the user feel about themself is wrapped up in the brand. For new medical devices, which are often seen and experienced by multiple users, it is essential to have a memorable identity. A memorable brand enables products to differentiate themselves from the competition, attract investors and partners, and generate stakeholder alignment. Built around core values, the brand sets guardrails for marketing teams and allows pricing teams to charge based on the value the brand provides. Setting a brand often means creating a logo and color scheme, choosing and right typography, and creating an icon set. Using our process the process cuts much deeper and goes to the basic psychological motivations of users, generating an emotional connection with the device and the company itself.

Hamilton MicroLab Prep Industrial Product Design
Hamilton MicroLab Prep Product Design Firm

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. We employ our psycho-aesthetic approach to solve user needs, and create emotional experiences that resonate with the user on an emotional level, turning them into product heroes. At the same time, we employ the latest tools: augmented reality SDKs, AI based facial tracking and body tracking/scanning, natural language processing with Amazon Lex, blockchains including smart contracts, decentralized security and privacy frameworks, machine machine learning algorithms and deep learning with TensorFlow and sci-kit, video and image processing, HIPAA compliance and attestation, on-device hardware integration, IoT and beacons, and 3D imaging using OpenGL.

Medical Device Software Development

Software is increasingly the most important touchpoint of a medical device. However, as an industry the medical device industry has not historically focused on software. For each project, we consider the implication of software needs, and 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.

Experience Design

The experience of a product is a combination of the UI, and UX, and branding of the experience. This experience must often comply with regulatory guidance, while providing an excellent UX and UI. During all stages of our medical product design and engineering process we apply usability testing, formative testing, human factors validation testing, and usability engineering for risk management. Due to their life-saving nature device experience must often comply with regulatory guidance and requirements, including: FDA Guidance 1757: Applying Human Factors and Usability Engineering to Medical Devices; AAMI/ANSI HE75:2009 Human Factors Engineering – Design of Medical Devices; AAMI/ANSI/IEC 62366-1:2015, CE marking (Europe); and Medical Devices Directive 93/42 EEC (Europe). We consider these requirements throughout our process.

Discus Dental Nuance Syringe design elements
Medical Device Usability Testing & Engineering

Medical device designers must conduct human factors validation testing to demonstrate that the intended users of a device can operate the product to perform the intended uses in the intended use environment. Otherwise known as usability engineering, the goal of these requirements are to ensure that the device has been optimized to eliminate, or reduce to the furthest extent possible errors that could cause harm to a patient. We conduct formative studies on product prototypes with representative users to answer design questions, identify strengths, probe for weaknesses, and detect potential errors that may occur while using a product. We also work with medical device manufacturers to craft our research around risk analyses that identify the risks associated with device utilization and the KPIs that have been chosen to reduce those risks.

Medical Device UX Design

Professional clinical-grade medical devices must be held to a high standard in their performance, accuracy, and usability. In order for those higher standards to be met, the UX of those medical devices must be considered from research, through design, development, and on to manufacturing. We consider all aspects of the product from it’s physical dimensions, technical limitations. at the outset, we’re trained to empathize not only with the end-user, but with the various parties involved with the development of a new medical device.

Hamilton MicroLab Prep Industrial Product Design
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. The wrong press of a button when using a computer may delete a document, but the wrong press of a button when administering medicine through an infusion pump, may be an overdose. As a result of these human-scale issues for medical devices, simplicity and efficiency are paramount. We consider the UI during all parts of our process, in order to make sure that all stakeholders can 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 product. Much of what a product makes the user feel about themself is wrapped up in the brand. For new medical devices, which are often seen and experienced by multiple users, it is essential to have a memorable identity. A memorable brand enables products to differentiate themselves from the competition, attract investors and partners, and generate stakeholder alignment. Built around core values, the brand sets guardrails for marketing teams and allows pricing teams to charge based on the value the brand provides. Setting a brand often means creating a logo and color scheme, choosing and right typography, and creating an icon set. Using our process the process cuts much deeper and goes to the basic psychological motivations of users, generating an emotional connection with the device and the company itself.

Hamilton MicroLab Prep Product Design Firm
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. We employ our psycho-aesthetic approach to solve user needs, and create emotional experiences that resonate with the user on an emotional level, turning them into product heroes. At the same time, we employ the latest tools: augmented reality SDKs, AI based facial tracking and body tracking/scanning, natural language processing with Amazon Lex, blockchains including smart contracts, decentralized security and privacy frameworks, machine machine learning algorithms and deep learning with TensorFlow and sci-kit, video and image processing, HIPAA compliance and attestation, on-device hardware integration, IoT and beacons, and 3D imaging using OpenGL.

Medical Device Software Development

Software is increasingly the most important touchpoint of a medical device. However, as an industry the medical device industry has not historically focused on software. For each project, we consider the implication of software needs, and 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

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.

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.

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.
Medical Device Design Spotlight
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FAQ's

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.

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.

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.
Medical Device Design Spotlight
Allergan
Ergonomic syringe development to enable doctors to perform procedures to enhance beauty and maintain youth.
Discus Dental

Advanced dental composite syringe to enhance usability for dental assistances and outperform the competition.

Talis Biomedical

A brand that focuses on bringing excellence to the field of point of care diagnostics.

Experience more of our Medical Devices