Expertise | Medical Device Design

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Expertise | Medical Device Design

Services

Design research icon
Innovation strategy icon
Inverted Color Branding Design Firm
Product Design Icon
UX UI Icon Invert Color Red
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Inverted Color Product Development Icon
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Markets

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Industrial Design Icon
Consumer Durable Design Icon

Markets

Medical

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Consumer

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CPG

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Industrial

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Durables

Services

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Research

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Innovation

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Over the years we have developed and implemented work in the following medical-related areas/spheres: consumer healthcare devices, diagnostic devices, drug device delivery, handheld surgical devices, human factors and usability testing, intellectual property support, medical device development, mobile medical devices, patient monitoring, rehabilitation devices, and digital interface design. In addition we offer services in research, product design, industrial design, 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 is a comprehensive medical device innovation, design, development, and engineering firm. Whether creating new medical products or improving existing ones, we assist at all stages of a product’s life cycle. We use our advanced psycho-aesthetic process to solve complex problems that address design, engineering, brand, and regulatory issues. Our cross-disciplinary specialists, researchers, designers, and engineers leverage their deep experience within multiple industries and technologies to spark creative and innovative solutions.

Our Clients

Our Unique Advanced Design Thinking Process

Psycho Aesthetics (P/A) is our unique approach to design thinking. 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 shared objective, pragmatic, and insightful approaches to everything 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 mapping onto a consistent framework combined with the creation of a “hero’s journey” for all stakeholders, from consumers to members of our own teams. 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.

Research Design

In most cases, designers are not the users of the medical devices. 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.

Ethnographic Research 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.

Medical product design

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?

Medical device design for services and systems

Medical device design goes beyond the device itself. Often, medical devices are joined by a combination of systems and services that need to be understood by and provide service to all stakeholders. These services and systems usually require the same type of thoughtfulness of design that the devices themselves require. Knowing this our design team considers the device in many contexts, from beginning to end. We consider not only the systems that medical devices operate in, but also the new systems that need to be created. We also consider the services that often need to be provided with new medical devices such as replacement, disposal, and maintenance. The help that medical devices can provide to stakeholders is immense, and we take our responsibility in creating these devices seriously. Successful devices will not only provide excellent care, but also be successful in the market. A product must find the right product-market fit to reach its full potential. As a result, our design process considers the needs of the market as one of the key stakeholders for these devices.

Medical device market

The medical device market is evolving with needs for new devices and capabilities all the time. The systems and services that support these devices are often drivers of the required innovation that comes with increasing life expectancies and demands on the quality of care around the world. The market of these devices is dynamic and often require quick-turnaround of impact ideas. We understand the market forces, and we adapt the changing needs of the market. We have continuously used our deep knowledge of medical device design to drive down the time it takes to complete a project.

Our Unique Advanced Design Thinking Process

Psycho Aesthetics (P/A) is our unique approach to design thinking. 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 shared objective, pragmatic, and insightful approaches to everything 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 mapping onto a consistent framework combined with the creation of a “hero’s journey” for all stakeholders, from consumers to members of our own teams. 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.

Research Design

In most cases, designers are not the users of the medical devices. 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.

Ethnographic Research 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.

Medical product design

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?

Medical device design for services and systems

Medical device design goes beyond the device itself. Often, medical devices are joined by a combination of systems and services that need to be understood by and provide service to all stakeholders. These services and systems usually require the same type of thoughtfulness of design that the devices themselves require. Knowing this our design team considers the device in many contexts, from beginning to end. We consider not only the systems that medical devices operate in, but also the new systems that need to be created. We also consider the services that often need to be provided with new medical devices such as replacement, disposal, and maintenance. The help that medical devices can provide to stakeholders is immense, and we take our responsibility in creating these devices seriously. Successful devices will not only provide excellent care, but also be successful in the market. A product must find the right product-market fit to reach its full potential. As a result, our design process considers the needs of the market as one of the key stakeholders for these devices.

Medical device market

The medical device market is evolving with needs for new devices and capabilities all the time. The systems and services that support these devices are often drivers of the required innovation that comes with increasing life expectancies and demands on the quality of care around the world. The market of these devices is dynamic and often require quick-turnaround of impact ideas. We understand the market forces, and we adapt the changing needs of the market. We have continuously used our deep knowledge of medical device design to drive down the time it takes to complete a project.

Ion Proton DNA Sequencer and other examples of RKS Medical Design Device Design

Industrial Design

We prioritize functional industrial design that emphasizes intuitive creativity and calculated scientific decision-making in creating and updating devices. We’re committed to creating impactful products and 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 process has become game-changing, as medical devices continue to look and act more like consumer products. We begin by using our psycho aesthetics research process to understand the critical needs of our users and determine the areas where we can create the most value.

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 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 development creates our framework for our technologies. The roadmapping process is conducted in three phases: preliminary activities, the development of the roadmap, and the follow-up activities phase. 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.

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.

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

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 future technologies, global trends, and 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

Medical Devices have more compliance requirements than most products. Often these requirements create minimum specifications for the form, function, and technologies used in 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.

Industrial Design

We prioritize functional industrial design that emphasizes intuitive creativity and calculated scientific decision-making in creating and updating devices. We’re committed to creating impactful products and 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 process has become game-changing, as medical devices continue to look and act more like consumer products. We begin by using our psycho aesthetics research process to understand the critical needs of our users and determine the areas where we can create the most value.

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 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 development creates our framework for our technologies. The roadmapping process is conducted in three phases: preliminary activities, the development of the roadmap, and the follow-up activities phase. 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.

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.

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

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 future technologies, global trends, and 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

Medical Devices have more compliance requirements than most products. Often these requirements create minimum specifications for the form, function, and technologies used in 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.

Hamilton Mobile Ventilator

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 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.

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 absolutely essential to have a memorable identity. A memorable brand enables products to differentiate themselves from the competition, attract investors and partners  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 it cuts much deeper and goes to the basic psychological motivations of users.

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, blockchain technologies 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 beacon technologies, and 3D imaging using OpenGL.

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 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.

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 absolutely essential to have a memorable identity. A memorable brand enables products to differentiate themselves from the competition, attract investors and partners  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 it cuts much deeper and goes to the basic psychological motivations of users.

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, blockchain technologies 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 beacon technologies, and 3D imaging using OpenGL.