Interaction Design for Medical Systems (Whitepaper)

Table of ConTenTs1. INTRODUCTION — 32. REGULATORY PERSPECTIVE ON DESIGN — 43. FROM ENGINEERING TO DESIGN — 54. POWER OF USER RESEARCH — 75. ITERATIVE DESIGN PROCESS — 11 5.1. Product Conception Phase — 14 5.2. Design Framework Phase — 16 5.3. Detailed Design Phase — 186. PRODUCT DOCUMENTATION — 207. ORGANIZATIONAL STRUCTURE — 238. CONCLUSION — 259. REFERENCES — 26Case sTudy example IndexUSER RESEARCH — 10DESIGN PROCESS — 19DOCUMENTATION — 22 Whitepaper • Interaction Design for Medical Systems 2

1. InTroduCTIon Have you ever sat in product development meetings where severalDOUBLE-EDGED SWORD OF CHANGE team members expressed strong and differing opinions about what “the user” really wants? Have you ever experienced delaysWhen products are hard to use, they cause people while team members struggle to articulate and finalize productpain. That pain may be largely psychological, as in the requirements? Or have you ever managed a project where the basicfrustration of a nurse who has to enter a standard product mandate changed late in the development phase?value into a system over and over. But in the case ofsome critical medical systems, that pain may actually As somebody in charge of planning and managing medical systembe physical: picture the despair of an elderly patient development, you’re solving challenging problems on a daily basis.who lives alone when she fails to tighten a small You have to balance efficacy with safety, and build products yourconnector with her arthritic fingers. customers actually want to buy. You also need to ensure regulatory compliance while controlling development costs and gettingPerhaps you feel the pain of your customers’ bitter your product to market as fast as possible. Adding complexity tocomplaints, or the squeeze of disappointing sales today’s medical systems, they often involve a large measure offigures. Perhaps you recognize that the medical user interactivity, whether your users are physicians, clinicians,systems you develop aren’t easy to use. Such painful administrators or patients. The last things you need are unclearinsights are the first steps towards embracing change. requirements and shifting mandates.Change isn’t always easy. It’s rare that people change Help is at hand from the discipline known as Interaction Design.simply for the good of changing, and research has Interaction Design practitioners work to ensure that your users willshown that people are usually only ready for change have a satisfying experience with your medical products and services.when they actively feel pain in their current situation. Interaction Design offers tools that help you determine what your[Nadler] users really need and applies processes that deliver solid solutions.Introducing Interaction Design activities to your This whitepaper first will explain that regulatory agencies regardmedical system development process likely means design activities for medical systems in a very positive light. Thenbringing change to your organization. It isn’t always we’ll discuss the innovative nature of design thinking by comparinggoing to be easy, but it’s far preferable to pursue Interaction Design to more well-known engineering disciplines.this effort now, before some extremely painful event Next, several key Interaction Design methods that benefit product— such as failing to obtain pre-market approval or development will be introduced, supported by case study examples.suffering a product recall — forces it upon you. These methods include: user research; the iterative design process; and requirements documentation. Finally, this whitepaper considers some ways that Interaction Design practitioners can operate successfully within a large organization. Whitepaper • Interaction Design for Medical Systems 3

2. regulaTory perspeCTIve on desIgn“Simply put, the risk of having use-related errors inmedical systems is minimized when the organization The American and European regulatory agencies FDA and TÜV bothunderstands its users and fully incorporates design espouse a user-centered approach to medical system developmentprocesses into the product development lifecycle.” that is strongly in keeping with the core principles and practices of Interaction Design. The FDA writes that: “The majority of use error is human in origin, and these mistakes can often be attributed to poor system design.” [FDA] Refer also to the figure at left for the IEC’s depiction of how human-centered design controls should operate to inform an iterative development cycle. Happily, this iterative process is a fundamental tenet of Interaction Design practice. One of the most pertinent American regulatory document considered mandatory today is entitled “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management: Identifying, Understanding and Addressing Use-Related Hazards.” [Kaye] Regulatory professionals have likely read the other most relevant publications [CDRH, FDA, Sawyer]. The international IEC 60601-1 standard on Risk Management and collateral standard 60601- 1-6 on Usability as well as AAMI HE-74:2001, Human factors design process for medical devices. also point to the positive results that design processes offer by focusing on users throughout iterative development stages and thus mitigating risk. The regulatory agencies’ focus on the risk of use-related hazards is noteworthy. Calculating the return on investment (ROI) for design activities is notoriously difficult due to the challenge of isolating the impact of design activities among other product development activities. Many experts have concluded that ROI is the wrong Regulatory model of good human-centered design process [IEC] metric by which to judge design because it’s a tactical measurement whereas design is a strategic initiative. [Dray] Instead, we can reframe the rationale for design as one of risk management. Simply put, the risk of having use-related errors in medical systems is minimized when the organization understands its users and fully incorporates design processes into the product development lifecycle. Whitepaper • Interaction Design for Medical Systems 4

3. from engIneerIng To desIgn The field of Interaction Design seeks to improve the human condition by improving people’s interactions with technology. Interaction Design focuses on defining the behaviors of interactive products and systems based on an understanding of how and why people need to use them. In defining system behaviors, Interaction Design addresses the system’s presentation to users and how that presentation makes people feel and respond. The essential practices of Interaction Design address the hands-on user experience. The first use of the term “Interaction Design” in the mid- 1980s is credited to Bill Moggridge, founder of IDEO, along with pioneering designer Bill Verplank. [Moggridge 14] Alan Cooper advanced and popularized the discipline by founding a dedicated consultancy called Cooper Interaction Design in 1992 and publishing two seminal books on the subject. [Cooper et al.; Cooper] In the medical industry, the disciplines of Human Factors Engineering and Usability Engineering are much more frequently represented in the organization compared to Interaction Design. Human Factors Engineering originated during the 1940s in the aeronautical industry, along with the study of ergonomics. It aims to ensure that systems accommodate the cognitive and perceptual limitations of human beings. Usability Engineering evolved later within the academically-grounded field of study called Human-Computer Interaction. Its core methods focus on analyzing, testing and inspecting systems for maximal usability.The daunting complexity of World War II cockpits such as this Boeing Although both Human Factors and Usability Engineering reachB-17G Flying Fortress caused fatal crashes, which showed the out towards the design of interactive systems, these engineering-importance of having machines adapt to human constraints instead of based disciplines emphasize analytical and evaluative skills versusforcing people to adapt themselves to machines. creative and generative skills. Instead of trying to measure users’ abilities and test system performance, Interaction Design seeks to understand users’ needs and motivations in order to inform system Whitepaper • Interaction Design for Medical Systems 5

behavior. Interaction Design delivers tangible user-centered insightsand product innovation using methods that blend analytical andcreative thinking. “The essential practices of Interaction Design addressJust as the study of medicine and science is undergoing a shift from the hands-on user experience. Satisfied users make fora Newtonian, mechanical-world orientation to a more Darwinian, successful companies. The medical industry is ripe for abiological-world orientation, product development today is strong company to stake a claim to great design.”experiencing a shift from engineering-based practices to design-based practices. The power of design thinking is reaching criticalmass with technology business leaders today as a key differentiatorin competitive marketplaces. [Wasserman] Although some novelmedical technologies may not be faced with a crowded market, COMPANY GAIN IN VALUEthat’s likely to be a temporary state of affairs. Today, we can observe (2000-2004)rapid commodification of even such sophisticated medical systems asinsulin pumps or pacemakers.Most people desire to have a good-quality experience with thesystems they use. Popular online services such as Get Satisfactionand Angie’s List let people educate themselves about the quality ofproducts and services before making their purchase decision. Therise of social networking services also magnifies the speed with whichbad user experiences can be broadcast to the world. Medical systemsare not going to be immune from this broader movement. On thecontrary, the medical industry appears ripe for a strong company tostake a claim to great design, the way Apple has claimed that groundin computing technology and consumer devices.Satisfied users make for successful companies. Recent studies byresearchers at the University of Michigan showed that a portfolio of Happy customers deliver corporate value [MSN]companies with the happiest customers gained 75% in value from2000 to 2004, dwarfing the 19% gain for the Standard & Poor’s 500Index during the same period; happy-customer companies were alsoless volatile and experienced less employee turnover. [MSN] Whitepaper • Interaction Design for Medical Systems 6

4. power of user researCh“User research involves understanding the behaviors,characteristics, motivations and needs of the Research is central to user-centered design thinking and practice.envisioned system’s end users. It doesn’t take a long While marketing departments often conduct research to assess thetime or cost a lot of money.” viability of selling a product and engineering departments often conduct research to assess the feasibility of building a product, it often happens that nobody is responsible for conducting research to understand what makes a product satisfying to use. Knowing how to satisfy users is different than measuring a product’s usability. Usability is a very important quality of interactive systems, but it is assessed at the end of product development when a working product is available. By contrast, user research should be conducted prior to finalizing your product’s scope and certainly prior to defining the user experience. User research may not yet be widely applied in medical system development but it is a powerful strategic force for innovation. Unlike most marketing or academic research, user research is qualitative in nature. Such research involves obtaining an understanding of the behaviors, characteristics, motivations and needs of the envisioned system’s end users. Qualitative research methods differ markedly from quantitative ones such as surveys or Great medical products and services are viable, clinical trials because statistical validity is neither expected nor feasible — and also satisfying to use sought. For medical industry professionals, qualitative research may seem disconcertingly “fuzzy,” but obtaining useful customer data from small sample sizes has a solid history of successful application to product design. [Beyer et al. 38; Calde] Interaction Designers are trained to identify the behaviors of people and characteristics of the system that matter most to product success. Whether your current development effort involves ground- breaking trials to validate a novel algorithm or releasing iteration seven of a well-established product, user research with your target customers will reveal what people will find satisfying to use. It doesn’t take a long time or cost a lot of money. Clarifying the scope of your problem space up-front through user research methods can be extremely helpful in order to focus the later efforts of more costly implementation and production resources. Whitepaper • Interaction Design for Medical Systems 7

Research Method: EthnographyLess Appropriate Research Tools: Ethnography is a powerful qualitative research method that deliversFocus Groups & Surveys deep, valuable information about your user population in a relatively short period of time. As a user research tool, ethnography leveragesTwo research methods that can be inappropriately techniques developed in the fields of anthropological and sociologicalapplied to front-end product definition are focus research. Its practice involves designers & other product stakeholdersgroups and surveys. visiting users’ environments to observe and interview individuals performing the activities in question.Focus groups are a qualitative research tool, involvinga moderator presenting questions and inputs to a Personal engagement between the designer and user helps to uncovergroup of people in a controlled environment. Focus the motivations that drive people to perform and the specific designgroups don’t provide good design input because qualities that will result in satisfied customers. Design ethnographydesigners need to learn about the actual, specific conducted before your medical system development effort beginsbehaviors of individuals, not the quick responses helps to reveal product opportunities. Such direct observation ofof artificially-gathered groups. People are also users is an essential component of the applied design thinking thatnotoriously bad at self-reporting behaviors, and what generates innovative solutions. [Wasserman]users say may differ significantly from what theydo. [Nielsen] Lastly, focus groups can tend to be One of the key factors that design ethnography uncovers relates todominated by one or two strong-voiced individuals. people’s contexts of use. Contexts of use are those environmentsGenerally, focus groups should be reserved for where users will interact with your product or service. Understandingaddressing early-stage marketing issues such as the medical context of use especially helps to identify risk areas thatproduct viability and branding. must be mitigated. Medical systems are frequently used in special institutional settings such as hospitals and clinics that often involveSurveys are a quantitative tool where a hopefully- specific functional constraints such as 3rd-party systems being used inlarge set of people respond to a set of questions conjunction with yours. Conducting first-hand research in the field isposed by a researcher. They suffer from a basic essential to identifying such environmental issues.limitation in that they collect simple answers onlyto the questions asked, so they will tend to garner The artifacts and models produced by Interaction Designers aspeople’s opinions about surface issues. Again, outputs from user research are retained during all subsequentthey don’t provide deep insights about people’s product development efforts. Such data-driven models establish abehaviors and goals needed to properly define user-centered foundation that helps keep teams on-target with theirinteractive systems. Generally, surveys should be feature-level decisions during later stages of product development.reserved for addressing product management issues Those often-frustrating opinions from various team members aboutsuch as competitive benchmarking or feature list what “the user” wants can be assessed in light of real-world dataprioritization. collected in the field. Documenting user research allows your entire organization to benefit from the work of the research team. Whitepaper • Interaction Design for Medical Systems 8

Research Model: Personas EXAMPLE PERSONAOne of the most powerful user research models that can be builtfrom design ethnography is called a Persona. Personas are fictionaluser archetypes. Persona descriptions may read like a story but theyare properly based on research data. [Bacon et al.] Personas embodyessential behavioral patterns among target users. Using a friendlyand approachable narrative format, they describe users’ key tasks,attitudes, motivations and workflows.Personas help identify product opportunities and clarify use-relatedrisks. The activities of design ethnography involve understandingpeople’s motivations and existing workflows. Personas embody thosefindings. Analyzing why people do things and how people do things Dr. Helena Reardoncan generate innovative solutions for ways that the newly-designed Interventional Cardiologistsystem can support personas’ goals more directly. Personas reveal Dr. Reardon performs a variety of surgical procedureswhen the new product can reduce or eliminate any frustrating or every day starting at 7am. She sees her daily scheduleredundant steps in the user’s current workflow. when she arrives to the hospital and scrubs down outside the operating room. Most proceduresRich, data-driven personas also facilitate communication and user- are relatively routine surgical ablations and devicecentered decision-making. They allow the product team to share implantations, but her case load of biventriculara common understanding of target users. Team members can now implants has been increasing. Biventricular implantsreference a specific individual persona and ground their decisions in can take hours to complete since placement ofa shared understanding of who exactly is being served. There’s no the left ventricular lead involves tricky intravenousmore arguments over what “the user” wants, because specific users navigation. She welcomed the introduction of RFare clearly understood by the whole team. Because realistic personas telemetry to remove the barrier of the sterile fieldgenerate empathy, they also encourage team members to remain between herself and industry representatives, butcommitted to delivering a high-quality, satisfying user experience. she’s frustrated whenever telemetry is lost because itPersonas are also a powerful planning tool. Personas help product slows her down. Dr. Reardon’s goals include:managers prioritize target users and control scope. The designated • Have information at her fingertipsprimary persona has needs that must be served entirely by the design • Trust her toolssolution, while secondary personas have additional needs that must • Experience no surprisesbe served in some area. The needs of supplemental personas, whoare fully served by the solutions devised for primary and secondarypersonas, are not allowed to impact the design solutions. Personas This abbreviated persona description was developed for examplealso work seamlessly with a scenario-based approach to Interaction purposes only and is property of Devise LLCDesign, which will be discussed in the following chapter. Whitepaper • Interaction Design for Medical Systems 9

Case Study Example: User ResearchAt St. Jude Medical’s Cardiac Rhythm Management Division, the design devices and information between people. Workflow variations wereteam used ethnography to study the pacemaker and ICD implantation identified between pacemaker and ICD implants, as well as around theprocedure for a new Pacing System Analyzer product that tests use of specialized tests and how test results were recorded.implanted lead functions before the medical device is secured in thebody. The design team spent several days in the field, interviewing Personas were created for the Sales Representative who usuallyphysicians and sales representatives and attending about a dozen operates the Pacing System Analyzer; the Implanting Physician andimplantation procedures. Physician’s Assistant who handle the surgical procedure; and also the Nurse who supports everybody else in the O.R. Identifying the SalesAfter studying the actual work performed in operating rooms, the Representative as the primary persona clarified the target user’sdesign team produced helpful documentation to share with the rest needs. Recognizing the variety of personnel, tools and workflowsof the product team. Modeling the maintenance of the sterile field in involved in the implantation procedure let the product team identifya crowded workspace revealed challenges for the smooth transfer of and mitigate risks such as switching between medical systems. Users are best understood in context Images this page Sarah McDevitt Whitepaper • Interaction Design for Medical Systems 10

5. ITeraTIve desIgn proCess Most product development efforts will begin with problem identification, which properly should be informed by market research, technology research and also user research, as discussed in the previous chapter. As a project proceeds toward its goal of successful implementation and market release, application of core Interaction Design processes can deliver more rapid and cost-effective results than a project without such design involvement. Design is a fundamentally iterative problem-solving activity. The tools and methods applied throughout the Interaction Design process are flexible and adaptable for each problem’s unique set of inputs and constraints. Also, the basic Interaction Design process can integrate well with your existing software development process, whether it’s a waterfall or Agile development model. Design Stages The core design process involves three stages of thinking, making and validating: • Ideation: conceiving potential solutions • Modeling: giving form to envisioned solutions • Testing: ensuring solutions are appropriate and satisfying Moving repeatedly through successive Ideation, Modeling and TestingThe core Interaction Design process moves iteratively through the stages, the outputs of each design stage iteration generate solutionsstages of Ideation, Modeling and Testing of increasing fidelity and correctness, always centered around the needs of the target user. “Because the core design process described here integrates with up-front development efforts such as requirements documentation, they do not add significant additional time or cost. What they do is reduce risk and eliminate guesswork throughout the project. ” Whitepaper • Interaction Design for Medical Systems 11

Project PhasesViewed at a higher level, iterations of these three design stagesunfold across three consecutive project phases:• Product Conception: determining the overall scope of the system, defining requirements and envisioning the high-level nature of the product• Design Framework: defining the underlying structure of the user experience and giving form to the features needed by primary and secondary personas• Detailed Design: addressing all aspects of user-system interactions and finalizing the visual look and feel of the system’s presentationDesign activities can move quickly and seamlessly through multipleiterations of the core design stages at each phase of the project. Forexample, during the Design Framework phase of a project, designstages could move through an iterative flow such as: IdeationModeling IdeationModelingTesting IdeationModelingTestingbefore emerging and moving on to the Detailed Design project phase.Each design stage could last between a few days and a few weeks,depending on the exigencies of your project schedule. Each projectphase could last between a few weeks and a few months, againdepending on schedule pressures. Because the core design processdescribed here integrates with up-front development efforts such asrequirements documentation, they do not add significant additionaltime or cost. What they do is reduce risk and eliminate guesswork Successive iterations of the design process stages within each of thethroughout the project. project phases deliver solutions of increasing fidelity and correctness leading towards implementation (waterfall model shown). Whitepaper • Interaction Design for Medical Systems 12

Architecting a HouseAn example from the field of architecture illustrates the importance including its visual and tactile characteristics. At each phase,of iterating design work across several phases. When conceiving a the architect is ideating, modeling and testing out ideas withhouse, the architect begins with understanding its residents and increasing levels of fidelity, from paper sketches to scale models andlocating the house’s foundation on the property. Then the architect perspective drawings. Changing the shape of the foundation late indefines the relationships between rooms as well as their principal the project would be a costly disaster. Throughout the project, thefeatures, and ensures that load-bearing walls are placed correctly. architect also collaborates with the client as well as people who willFinally, the architect addresses the finer features of the house, be charged to build and outfit the house. PRODUCT CONCEPTION DESIGN FRAMEWORK DETAILED DESIGNQuestions being answered include: Questions being answered include:• For whom exactly is this house being Questions being answered include: built? • How many bathrooms are needed?• Where should the house be situated on • What’s the exact relationship between • What style faucets should be installed? the property? the kitchen and the dining room? • What kind of material should cover the• How big will the dwelling be? • Does the scale model reveal any kitchen floor?• What qualities of the house are most feasibility or usability issues? • What is the cost of a given material important to the client? • Are the hallways wide enough to comply choice? with safety codes? • Would the resident like a large bay window in the living room? Whitepaper • Interaction Design for Medical Systems 13

5.1. PRODUCT CONCEPTION PHASEPRODUCT CONCEPTION PHASE The Product Conception phase is focused on clarifying the overall vision of the system and devising product features that serve that scope. Testing concepts with users along the way helps to validate the envisioned product scope. Product Conception: Ideation An important first kind of Ideation is brainstorming. Brainstorming sessions are a productive time for all project team members to share their favorite design ideas and feature solutions. Brainstorming is the right time to collect wild concepts without judgment and feed them into the mental hopper for further analysis and consideration; even the most “infeasible” concept may have a germ of design value or represent a new market opportunity. No single group can or should exclusively own product innovation. Also at this juncture, the Personas identified from design research can be classified into their primary, secondary and supplemental designations. This prioritization of target users strongly influences the design decisions to follow. This activity must be highly collaborative with key product stakeholders due to its strategic impact. Balancing primary and secondary persona needs can facilitate product feature prioritization during this phase and subsequent project phases. Also, remembering that supplemental personas are out of scope can help control feature creep.Design process methods and outputs of Product Conception phase Product Conception: Modeling For Modeling initial product concepts, many Interaction Design practitioners employ a scenario-based methodology. Using the primary and second Personas chosen by the team, ideal usage scenarios are written. These usage scenarios represent the target user’s high-level interactions with the system across the product lifecycle. User goals and motivations are considered deeply in order to help the team generate innovative improvements over existing workflows. Freshly-conceived solutions at this juncture can often eliminate time-wasting tasks and frustrations that might exist in Whitepaper • Interaction Design for Medical Systems 14

the personas’ current world. Because Modeling focuses on solidifyingconcepts and scope, design outputs take low-fidelity forms such aswritten scenarios and whiteboard sketches.Product Conception: TestingIn the first Testing stage, any low-fidelity design outputs can betested internally by reviewing Personas, scenarios and other modelswith a cross-disciplinary team. Team members can help identifyrequirement gaps or feasibility concerns with the proposed productvision. Models of existing workflows can be compared to the newusage scenarios to identify where new product concepts bettermitigate risk. If any new risks are identified, an iteration backto Ideation ensues to ensure that no risk moves forward withoutappropriate mitigators in place.Testing concepts with real users also can be conducted duringthis phase. One type is called Directional Testing, which involvespresenting multiple visual concepts to users and soliciting theirfeedback on which direction the company should pursue. This testingis useful in the event that multiple product concepts are beingconsidered or different visual brands are being evaluated. Like designresearch, this activity should be conducted in one-on-one sessions tominimize group-think.Concept Testing is another helpful tool for this phase of a project. Testing during the Product Conception phase involves figuring outThis activity involves seeking validation for the product scope from what will make it flymembers of the target market, and can aid help identify the relativeimportance of product features. Focus groups and surveys canbe used productively here; quantitative survey tools can validatecustomers’ feature priorities and provide statistically-valid data “The first project phase, Product Conception, willthat tends to resonate with upper management at medical systems usually involve brainstorming, usage scenarios,companies. and some form of concept testing. Usage scenarios represent the user’s high-level interactions across the product lifecycle, and help the team to generate innovative features and mitigate risk.” Whitepaper • Interaction Design for Medical Systems 15

5.2. DESIGN FRAMEWORK PHASE After the foundation is laid for the product concept, the DesignPRINCIPLES AND PATTERNS Framework phase involves defining the overall user experience. Design Framework Modeling produces manifestations of the productInteraction Design practitioners will refer features that are deemed in-scope, while Testing at this junctureto proven principles and patterns during the validates design choices and identifies areas for further refinement.Modeling stage. Several noteworthy principlesand patterns include: Design Framework: Ideation Interaction Design practitioners can use the scaffolding of usage• Don’t make the user feel stupid. [Cooper 97] scenarios and persona goals to conceive the appropriate design This principle may capture the moral essence framework. The ultimate user experience must deliver the right of interaction design and is extraordinarily functionality in the right form at the right time. Ideation at this pertinent for medical systems used by phase tends to be approached both visually and verbally, using a physicians. combination of analytical and creative tools to address how the• Optimize for intermediates. [Cooper 45] system can best serve users needs. If this description sounds abstract, Few users remain beginners and few users that’s because ideation here is a relatively intangible design stage — become experts — the majority of users exist the artifacts that you can see are delivered through Modeling, next. somewhere in-between, and need be served with interaction mechanisms suited to their Design Framework: Modeling level of expertise. Scenarios are expanded and deepened through successive conceptual• Global navigation. [Tidwell 66] Devote an iterations. High-level usage scenarios are broken down into key path appropriate portion of each interface to a set scenarios. On the visual side, initial whiteboard or pencil sketches of controls that take the user to key sections become digital wireframes. Wireframes are digital representations of of the application. This pattern gives control rough product functionality, with a low level of visual fidelity. Usually to users and provides reassuring consistency. they will consist of black-and-white outlines of key system states.• Progress indicators. [Tidwell 149] Show the Many designers will also proceed on to static mockups at this user how much progress is being made for any juncture. Mockups are higher-fidelity representations of the operation lasting longer than 2 seconds, even system, which integrate more visual polish into the product design. if the time estimate is imprecise. This pattern Storyboards can also bring scenarios and personas to life when a relieves user anxiety and makes people more designer is handy with drawing figures or has access to life-size patient. models. One of the more important tools commonly employed by Interaction Design practitioners modeling the design framework include principles and patterns. These may come from experts and publications, while others are developed as internal design standards Whitepaper • Interaction Design for Medical Systems 16

for product families or exist as competitive standards within DESIGN FRAMEWORK PHASEestablished industries. Some medical design frameworks, such asgames that are intended to promote health or products aimed atengendering a healthy lifestyle, may also need to consider emotionalaffects such as playfulness and fun to ensure user engagement andpatient compliance.Design Framework: TestingAt this phase, Testing generally involves additional user research. Asthe product models gain fidelity, a qualitative user research methodcalled Usability Testing can be applied to refine and validate proposedsolutions. Usability testing is a way of measuring usability and usersatisfaction by presenting potential and current users with some formof product model. These product models vary in resolution dependingon the maturity of the project; at the Design Framework phase theywill tend to comprise paper prototypes of the wireframes or staticmockups but could involve an interactive prototype.Usability Testing involves presenting product models to users inexperimentally-controlled, one-on-one sessions. Such testing withreal people can reveal a wealth of information about the designframework’s strengths and weaknesses. Usability Testing is a provenrapid and cost-effective research technique. Studies of usabilitytesting show that sessions conducted with as few as five users canreveal 85% of a product’s total usability problems. [Nielsen]Applied in an iterative fashion, multiple rounds of usability testing Design process methods and outputs for Design Framework phaseduring the Design Framework phase can augment the design process.To summarize the results for team consumption, usability test reportswill highlight users’ response patterns and identify areas of the “The Design Framework phase involves defining the overallproduct that could use further design refinement. user experience. Designers use wireframes and mockups and apply principles and patterns to model solutions. Usability Testing is a proven rapid and cost-effective research technique to validate the design framework.” Whitepaper • Interaction Design for Medical Systems 17

5.3. DETAILED DESIGN PHASEDETAILED DESIGN PHASE During this phase, the longest one of a medical system project, the product design is further articulated by defining detailed interactions between the user and system. The Interaction Designer works ever more closely with cross-disciplinary team members; in an Agile development environment, the Interaction Design team is working just one or two iterations ahead of the team. Design Framework: Ideation Ideation for detailed design is informed by the inputs from preceding Testing activities. Small interactions may require more attention. Ideation here can also be driven by the formalization of the product’s visual language and the initiation of product requirements documentation. Additional concepts will also tend to emerge and expand from the design patterns created by earlier solutions. Design Framework: Modeling By this phase, design models transition from wireframes to high- fidelity mockups at a minimum. Some organizations may find that static mockups satisfy their modeling needs when communicating with the development team. Higher resolution design models such as interactive prototypes can be extremely helpful as well. Rapid prototyping of primary personas’ key path scenarios can clarify any problems, and this iteration helps generate stronger solutions.Design process methods and outputs for the Detailed Design phase Design Framework: Testing Usability Testing activities can leverage interactive prototypes at this“During the Detailed Design phase, designers phase, if available. Interactive prototypes add richness and depth toarticulate product solutions with a realistic level of the feature behaviors that can be tested with actual users. Dependingfidelity, iterating mockups and potentially interactive on the prototype code’s closeness to the actual development language/environment, interactive prototypes can involve vettingprototypes. When Testing shows an acceptable level of product feasibility, too. Going to this length also tends to makeuser satisfaction, the design process transitions into a development team’s projected scope estimates more accurate.supporting role for implementation.” When Testing shows an acceptable level of user satisfaction, the design process transitions into a supporting role for implementation. Whitepaper • Interaction Design for Medical Systems 18

Case Study Example: Design Process At St. Jude Medical’s Cardiac Rhythm Management Division, one of the principal clinical platforms was completely re-envisioned using Interaction Design methods, including user research. The new product launched as the Merlin™ Patient Care System (PCS) and it features a large interactive touch-screen display. Product Conception The team designated the Pacer Nurse as the primary persona for the graphical user interface, marking a strategic shift from focusing primarily on the Electrophysiologist. Workflow analysis of the previous system showed that it didn’t accommodate the Pacer Nurse’s routine protocols well. Ideal usage scenarios were written based on observed real-world protocols, greatly reducing friction between the system design and the user’s expectations. The hardware form factor and Merlin PCS hardware platform visual branding were selected using Directional Testing. Design Framework The user experience was architected around the Pacer Nurse conducting a routine follow-up for both pacemakers and defibrillators. These steps were built into the overall navigational structure and the layout of each screen. Key functions such as parameter programming and device testing were heavily iterated through successive Ideation and Modeling stages. Design concepts and user interfaces were validated and improved with several rounds of Usability Testing with mockups and an interactive prototype. Detailed Design During this phase, all aspects of the system were fully articulated and refined within a waterfall development process. Solutions included: • defining elegant representations of large data sets • refining the visual language and documenting clear Graphical User Interface specifications • serving a different primary persona (the Electrophysiologist) for printed reportsInitial “FastPath Summary” screen for the Identity® ADx pacemaker • providing usage scenarios and high-fidelity mockups as design input to formal product requirements documents This case study is continued at the end of the following chapter. Whitepaper • Interaction Design for Medical Systems 19

6. produCT doCumenTaTIon As medical industry professionals know, medical product approvals are principally achieved through regulatory agencies’ review of departmental procedures and product documentation. This focus on process and documentation puts an extra strain on development organizations, since authoring and then maintaining requirements specifications can consume massive amounts of precious time and energy. When the Interaction Design team employs a scenario-based approach to design, the scenarios generated during the design process can be a useful and powerful tool to inform requirements. Usage scenarios are written at a high level starting in the Product Conception phase to envision the functionality of the system; because they describe the entire framework of the product or service, they transition well to be an input for requirements documentation. Employing user-centered scenarios in this way also helps to keep the development team’s focus on satisfying the target Persona. Scenario-based documentation works well with both waterfall and Agile development methodologies. In waterfall models, marketing departments often define the vision for medical products and services using Product or Marketing Requirement Documents (PRDs or MRDs). Including scenarios that are based on user research adds depth and clarity to PRDs/MRDs, establishing a foundational expectation of product scope that faciliates project scheduling and resourcing. Development groups may already utilize use case scenarios under a Rational Unified Process environment, for example. Such use cases are positioned and touted as a requirements generation activity, but too often the authors do not possess the right data about users’ needs in order to generate requirements that will truly satisfy customers. Having scenarios based on design researchScenarios support good as design input for use case scenarios provides requirements documentation authors with the right information to document the appropriate system and software requirements. Whitepaper • Interaction Design for Medical Systems 20

In Agile development methods such as SCRUM or Extreme Programming (XP), the scenario is an even more integral part of team communication techniques. User stories are abbreviated scenarios similar to the key path scenarios used by Interaction Designers during the Design Framework phase. Agile approaches emphasize putting a user role as the actor in these stories, and personas map extremely well to this approach. With Persona models at hand, the Agile development process will no longer require constant access to real end-users throughout implementation. Another best practice in medical systems development is having Interaction Design practitioners formally review requirements throughout requirements documentation and implementation phases. Doing so helps ensure that the defined features continue to reflect the behaviors indicated by user research and design inputs, and is another way in which Interaction Design helps reduce systemic risk. The Interaction Design practitioner is intimately familiar with the nuances of complex user-system interactions, and can more quickly identify requirements gaps and inaccuracies than most project team members. Design documentation can also inform user manuals, which are very important documents for both regulatory agencies and users. Informed by user research and Interaction Design processes, user manuals can not only include people’s real-world workflows as a educational tool, but they can also better employ the actual language“Usage scenarios transition well to be an input for and terminology of the target user population. Interaction Design thusrequirements documentation. Interaction Designers helps to bridge the gap between the medical industry professional informally review requirements to help ensure defined the corporate office and the medical system user in the field.features reflect the behaviors indicated by designresearch. Design documentation can also inform user Insights gleaned from user research and design thinking can alsomanuals and marketing activities.” aid medical systems’ marketing and sales activities. Knowing how customers behave and what motivates them allows marketing and sales representatives to pitch the most valuable benefits and features to the target audience. A similarly helpful use of design processes includes crafting a positive marketing message that resonates with the target market. Whitepaper • Interaction Design for Medical Systems 21

Case Study Example: DocumentationAt St. Jude Medical, the personas, scenarios and other models Additionally, when the Merlin PCS was launched, the marketing teamdelivered during the design process for the Merlin PCS were used the campaign slogan: “Designed by clinicians for clinicians”. Thisleveraged for formal product requirement documents. Each message resonated very positively with the target user population ofrequirements document began with one or more formal use case pacer nurses whose daily needs had too often been relegated belowscenarios that reflected the routine workflow of the primary those of physicians. The product’s ease of use, achieved through thepersona, and then branched into alternative and exception flows application of iterative, user-centered Interaction Design processes,for the primary and any secondary personas. Interaction Design became a significant selling point for the new system. St. Judeteam members were also key participants in every formal review of Medical’s market position moved from a distant third to a strongrequirements, helping keep implementation true to users’ needs. second as a result. Merlin PCS marketing brochure Whitepaper • Interaction Design for Medical Systems 22

7. organIzaTIonal sTruCTure Medical systems development is anything but a solo endeavor, and products frequently take multiple years to move from being a concept in someone’s mind to being released in the market. To deliver the most value, the Interaction Design practitioner should be a core team member from the first moments of problem identification through the end game of market launch. Generally, the discipline of Design (which may include Interaction Design; Industrial Design and/ or Visual Design) should have department-level representation in the organization. Establishing a solid foundation of user research about peoples’ needs enables teams to make better decisions without requiring constant direct user input, as discussed above. Throughout the development process, the Interaction Design practitioner becomes principally charged with representing the user’s perspective. However, users’ needs are not the only decision-driver in product development. Interaction Design practitioners must know how to balance the concerns of business and technology with those of users. Listening and collaboration are key Interaction Design skills for forging a shared team vision. Most practitioners are well-versed in cross-disciplinary teamwork. The importance of successful collaboration is established in academic design programs as well as being a best practice in industry. [Corporate] Interaction Design practitioners tend to operate at the intersection ofIn any serious medical systems company, a centralized various departments, as shown in the diagram at left. This situationInteraction Design team will collaborate with many parts of the is especially true for medical systems development because theorganization (other departments’ collaborations not depicted) initial vision for products usually begins within clinical, research or marketing departments while the end game of implementation is usually the responsibility of engineering departments. Interaction Design is not properly a marketing function, however, since marketing is focused on product viability and selling, nor is it properly an engineering function, which is focused on product feasibility and implementation. Whitepaper • Interaction Design for Medical Systems 23

Due to the way that Interaction Design practitioners collaborate withmany different departments, one of the more successful modelsfor large organizations is to create a centralized consulting group.Members of a central Interaction Design group can work on multipleprojects simultaneously, staffed according to the projects’ currentstage in the development process. Such a group can naturally becomea generalized Design department, housing Interaction Design as wellas Industrial Design and/or Visual Design team members as well.One useful service that an internal Design group can provide istraining other team members in user research and usability testing.Techniques such as those employed with ethnography support goodoutcomes for any activity where medical industry professionalswill be interacting with potential or current users and customers.Listening and interviewing skills that Interaction Design practitionersemploy for research to establish rapport with users can be taught toothers, and improved with practice.Creating an Interaction Design group raises the issue of properstaffing. This factor is influenced by size of your organization. Whilehighly-experienced Interaction Design generalists can seamlesslysupport user research, ideation, modeling and testing, manypractitioners tend to specialize in certain areas such as user researchor modeling. Ideally, an Interaction Design team will have senior, mid-level and junior staff with different levels and areas of expertise.Establishing a growth path for senior design staff is also important toretain talent—the kind of people who finally understand your complexdomain and technology, and know how to apply that understandingfor successful medical system development.To support the success of a Design department within a largeorganization, high-level executive support is crucial. A designated How can you get the most value from cross-disciplinary“design champion” can address the dynamics of how design impacts collaboration?the practices of other departments; s/he can help to evangelizeuser research and design activities. This step could even involve “Listening and collaboration are key Interactionappointing a Vice-President of User Experience or Chief Design Officer Design tools for forging a shared team vision.”in order to fully legitimize the important effort of establishing user-centered approaches throughout the entire organization. Whitepaper • Interaction Design for Medical Systems 24

8. ConClusIon Medical systems and Interaction Design both aim to improve the human condition. Interaction Design practices can greatly benefit medical systems development. Your medical systems can and should exhibit more than just viability, feasibility and even usability. Great medical products and services can deliver true satisfaction to people by offering a well- designed user experience. Bringing user research and iterative design processes to bear in your organization improves strategic product innovation and reduces systemic risk. Your customers, your business, and your peace of mind should benefit.Key take-aways:• Regulatory agencies strongly advocate the application of iterative, user-centered design processes to medical system development. Interaction Design offers rapid and cost-effective ways to reduce the risk of use-related hazards.• Iteraction Design applies at the front-end of product development, going beyond human factors and usability. It’s about defining innovative product solutions that satisfy customers — and satisfied customers make for successful companies. • User research methods such as ethnography help reveal product challenges and opportunities. Research models like Personas control project scope, and keep the team focused on real-world needs.• Iterating the design stages of Ideation, Modeling and Testing across the project phases of Product Conception, Design Framework and Detailed Design will deliver solid solutions. Usability testing helps to validate decisions and reduce risk prior to costly implementation.• Interaction Design methods and outputs offer benefits for requirements documentation and development efforts, as well as supporting marketing activities. Dr. Helena Reardon Persona• Establishing an in-house Interaction Design group benefits the whole organization. Ensure the Design department has a strong internal executive-level champion. Whitepaper • Interaction Design for Medical Systems 25

9. referenCes• Bacon, Elizabeth and Calde, Steve. “Death to Personas! Long Live • Kaye, Ron and Crowley, Jay. “Medical Device Use-Safety: Personas!”. <www.devise.com/further_reading>. Incorporating Human Factors Engineering into Risk Management:• Beyer, Hugh and Holzblatt, Karen. Contextual Design: Defining Identifying, Understanding and Addressing Use-Related Hazards.” Customer-Centered Systems. Morgan Kauffman Publishers: San Division of Device User Programs and Systems Analysis, Office of Francisco, 1998. Device and Industry Programs, Center for Devices and Radiological Health, U.S. Food & Drug Administration, Public Health Service,• Calde, Steve. “Design Research: Why You Need It“. <http://www. U.S. Department of Health and Human Services. <http://www.fda. cooper.com/journal/2003/03/design_research_why_you_need_i. gov/cdrh/humfac/1497.pdf> July 2000. html#more>. • Moggridge, Bill. Designing Interactions. The MIT Press: Cambridge,• Center for Devices and Radiological Health (CDRH), U.S. Food & Massachusetts, 2007. Drug Administration, Public Health Service, U.S. Department of Health and Human Services. “Human Factors Points to Consider for • MSN Money. “Happy customers, good stocks”. <http:// IDE Devices”. <http://www.fda.gov/cdrh/humfac/ide_hf.pdf>. articles.moneycentral.msn.com/Investing/CompanyFocus/ January 1997. HappyCustomersGoodStocks.aspx>.• Cooper, Alan; Reimann, Robert; and Cronin, David. About Face: • Nadler, David A. “Managing Organizational Change: An Integrative The Essentials of Interaction Design 3. Wiley Publishing, Inc: Perspective”. Journal of Applied Behavioral Science. April 1981 Indianapolis, IN, 2007. (First version published in 1995.) vol. 17 no. 2 191-211.• Cooper, Alan. The Inmates Are Running the Asylum. Macmillan • Nielsen, Jakob. “First Rule of Usability? Don’t Listen to Users”. Computer Publishing: Indianapolis, IN, 1999. <http://www.useit.com/alertbox/20010805.html>.• Corporate. The Joint Task Force on Computing Curricula. • Nielsen, Jakob. “Why You Only Need to Test with Five Users”. “Computing curricula 2001.” Journal on Educational Resources in <http://www.useit.com/alertbox/20000319.html>. Computing (JERIC), v.1 n.3es, Fall 2001. • Saffer, Dan. Designing for Interaction: Creating Smart Applications• Dray, Susan, et al. “Is ROI an Effective Approach for Persuading and Clever Devices. New Riders: Berkeley CA, 2007. Decision-Makers of the Value of User-Centered Design?” CHI 2005 • Sawyer, Dick, Officer of Health and Industry Programs, et al. “Do It Panel, April 2-7, 2004, Portland, Oregon, USA. ACM 1-59593-002- By Design: An Introduction to Human Factors in Medical Devices.” 07/05/0004. Center for Devices and Radiological Health (CDRH), U.S. Food &• Federal Drug Administration (FDA), Institute of Medicine. “To Err is Drug Administration, Public Health Service, U.S. Department of Human – Building a Safer Health System”. <http://www.fda.gov/ Health and Human Services. <http://www.fda.gov/cdrh/humfac/ cdrh/useerror>. November 1999. doitpdf.pdf>. December 1996.• IEC 60601-1-6 “Medical Electrical Equipment - Part 1-6: General • Tidwell, Jenifer. Designing Interfaces: Patterns for Effective requirements for safety — Collateral Standard: Usability” Draft Interaction Design. O’Reilly Media, Inc: Sebastopol, CA, 2005. dated 2002-05-14. • Wasserman, Todd. “Thinking by Design”. <http://www.brandweek. com/bw/content_display/news-and-features/packaging-and- design/e3i397aa99d2932d77d688976026b8e533e?pn=1>. Whitepaper • Interaction Design for Medical Systems 26

ABOUT THE AUTHORElizabeth Bacon is Chief Design Officer of Devise LLC. She holds a BAfrom Stanford University and MA from San Francisco State University.She began her interaction design career at Cooper Interaction Design,where she consulted on projects in domains ranging from enterprisesystems to medical devices and web-based telecommunications. Shesubsequently played a leading role for over five years in productplanning and interaction design for St. Jude Medical’s Cardiac RhythmManagement Division. Working on critical medical systems wasenormously rewarding. She has been granted multiple patents andpublished articles in various venues. She also recently served threeyears on the Board of Directors of the Interaction Design Association(www.IxDA.org), an international professional organization withover 20,000 members. In her free time, she practices competitivemotorsports, reads, writes, draws and spends time with her daughter.ABOUT DEVISEDevise LLC provides digital product design consulting services,specializing in User Research and Interaction Design. Visit Deviseonline at devise.com or Elizabeth can be reached at 503-292-5191.“Let’s Devise!” Whitepaper • Interaction Design for Medical Systems 27

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Interaction Design for Medical Systems (Whitepaper)

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