interaction design for medical systems (whitepaper)

Interaction Design for Medical Systems

Whitepaperby Elizabeth Bacon Principal, Devise Consulting

Document v1.2; v1.0 published Feb 24, 2011 Copyright © 2011-2013 Devise Consulting All rights reserved

Whitepaper • Interaction Design for Medical Systems 2

Table of ConTenTs

1. 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 — 18

6. PRODUCT DOCUMENTATION — 207. ORGANIZATIONAL STRUCTURE — 238. CONCLUSION — 259. REFERENCES — 26

Case sTudy example Index

USER RESEARCH — 10DESIGN PROCESS — 19DOCUMENTATION — 22


1. InTroduCTIon

Have you ever sat in product development meetings where several team members expressed strong and differing opinions about what “the user” really wants? Have you ever experienced delays while team members struggle to articulate and finalize product requirements? Or have you ever managed a project where the basic product mandate changed late in the development phase?

As somebody in charge of planning and managing medical system development, you’re solving challenging problems on a daily basis. You have to balance efficacy with safety, and build products your customers actually want to buy. You also need to ensure regulatory compliance while controlling development costs and getting your product to market as fast as possible. Adding complexity to today’s medical systems, they often involve a large measure of user interactivity, whether your users are physicians, clinicians, administrators or patients. The last things you need are unclear requirements and shifting mandates.

Help is at hand from the discipline known as Interaction Design. Interaction Design practitioners work to ensure that your users will have a satisfying experience with your medical products and services. Interaction Design offers tools that help you determine what your users really need and applies processes that deliver solid solutions.

This whitepaper first will explain that regulatory agencies regard design activities for medical systems in a very positive light. Then we’ll discuss the innovative nature of design thinking by comparing Interaction Design to more well-known engineering disciplines. Next, several key Interaction Design methods that benefit product development will be introduced, supported by case study examples. 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.

DOUBLE-EDGED SWORD OF CHANGE

When products are hard to use, they cause people pain. That pain may be largely psychological, as in the frustration of a nurse who has to enter a standard value into a system over and over. But in the case of some critical medical systems, that pain may actually be physical: picture the despair of an elderly patient who lives alone when she fails to tighten a small connector with her arthritic fingers.

Perhaps you feel the pain of your customers’ bitter complaints, or the squeeze of disappointing sales figures. Perhaps you recognize that the medical systems you develop aren’t easy to use. Such painful insights are the first steps towards embracing change.

Change isn’t always easy. It’s rare that people change simply for the good of changing, and research has shown that people are usually only ready for change when they actively feel pain in their current situation. [Nadler]

Introducing Interaction Design activities to your medical system development process likely means bringing change to your organization. It isn’t always going to be easy, but it’s far preferable to pursue this effort now, before some extremely painful event — such as failing to obtain pre-market approval or suffering a product recall — forces it upon you.


2. regulaTory perspeCTIve on desIgn

The American and European regulatory agencies FDA and TÜV both espouse a user-centered approach to medical system development 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 documents 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-75:2009, a companion standard to 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 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.

Regulatory model of good human-centered design process [IEC]

“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.”


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.

Although both Human Factors and Usability Engineering reach out towards the design of interactive systems, these engineering-based disciplines emphasize analytical and evaluative skills versus 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

The daunting complexity of World War II cockpits such as this Boeing B-17G Flying Fortress caused fatal crashes, which showed the importance of having machines adapt to human constraints instead of forcing people to adapt themselves to machines.


behavior. Interaction Design delivers tangible user-centered insights and product innovation using methods that blend analytical and creative thinking.

Just as the study of medicine and science is undergoing a shift from a Newtonian, mechanical-world orientation to a more Darwinian, biological-world orientation, product development today is experiencing a shift from engineering-based practices to design-based practices. The power of design thinking is reaching critical mass with technology business leaders today as a key differentiator in competitive marketplaces. [Wasserman] Although some novel medical technologies may not be faced with a crowded market, that’s likely to be a temporary state of affairs. Today, we can observe rapid commodification of even such sophisticated medical systems as insulin pumps or pacemakers.

Most people desire to have a good-quality experience with the systems they use. Popular online services such as Get Satisfaction and Angie’s List let people educate themselves about the quality of products and services before making their purchase decision. The rise of social networking services also magnifies the speed with which bad user experiences can be broadcast to the world. Medical systems are not going to be immune from this broader movement. On the contrary, the medical industry appears ripe for a strong company to stake a claim to great design, the way Apple has claimed that ground in computing technology and consumer devices.

Satisfied users make for successful companies. Recent studies by researchers at the University of Michigan showed that a portfolio of companies with the happiest customers gained 75% in value from 2000 to 2004, dwarfing the 19% gain for the Standard & Poor’s 500 Index during the same period; happy-customer companies were also less volatile and experienced less employee turnover. [MSN]

Happy customers deliver corporate value [MSN]

COMPANY GAIN IN VALUE(2000-2004)

“The essential practices of Interaction Design address the hands-on user experience. Satisfied users make for successful companies. The medical industry is ripe for a strong company to stake a claim to great design.”


4. power of user researCh

Research is central to user-centered design thinking and practice. While marketing departments often conduct research to assess the 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 typically assessed part-way through product development or even later when a working system 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 clinical trials because statistical validity is neither expected nor 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.

Great medical products and services are viable, feasible — and also satisfying to use

“User research involves understanding the behaviors, characteristics, motivations and needs of the envisioned system’s end users. It doesn’t take a long time or cost a lot of money.”


Research Method: Ethnography

Ethnography is a powerful qualitative research method that delivers deep, valuable information about your user population in a relatively short period of time. As a user research tool, ethnography leverages techniques developed in the fields of anthropological and sociological research. Its practice involves designers & other product stakeholders visiting users’ environments to observe and interview individuals performing the activities in question.

Personal engagement between the designer and user helps to uncover the motivations that drive people to perform and the specific design qualities that will result in satisfied customers. Design ethnography conducted before your medical system development effort begins helps to reveal product opportunities. Such direct observation of users is an essential component of the applied design thinking that generates innovative solutions. [Wasserman]

One of the key factors that design ethnography uncovers relates to people’s contexts of use. Contexts of use are those environments where users will interact with your product or service. Understanding the medical context of use especially helps to identify risk areas that must be mitigated. Medical systems are frequently used in special institutional settings such as hospitals and clinics that often involve specific functional constraints such as 3rd-party systems being used in conjunction with yours. Conducting first-hand research in the field is essential to identifying such environmental issues.

The artifacts and models produced by Interaction Designers as outputs from user research are retained during all subsequent product development efforts. Such data-driven models establish a user-centered foundation that helps keep teams on-target with their feature-level decisions during later stages of product development. Those often-frustrating opinions from various team members about what “the user” wants can be assessed in light of real-world data collected in the field. Documenting user research allows your entire organization to benefit from the work of the research team.

Less Appropriate Research Tools:Focus Groups & Surveys

Two research methods that can be inappropriately applied to front-end product definition are focus groups and surveys.

Focus groups are a qualitative research tool, involving a moderator presenting questions and inputs to a group of people in a controlled environment. Focus groups don’t provide good design input because designers need to learn about the actual, specific behaviors of individuals, not the quick responses of artificially-gathered groups. People are also notoriously bad at self-reporting behaviors, and what users say may differ significantly from what they do. [Nielsen] Lastly, focus groups can tend to be dominated by one or two strong-voiced individuals. Generally, focus groups should be reserved for addressing early-stage marketing issues such as product viability and branding.

Surveys are a quantitative tool where a hopefully-large set of people respond to a set of questions posed by a researcher. They suffer from a basic limitation in that they collect simple answers only to the questions asked, so they will tend to garner people’s opinions about surface issues. Again, they don’t provide deep insights about people’s behaviors and goals needed to properly define interactive systems. Generally, surveys should be reserved for addressing product management issues such as competitive benchmarking or feature list prioritization.


Research Model: Personas

One of the most powerful user research models that can be built from design ethnography is called a Persona. Personas are fictional user archetypes. Persona descriptions may read like a story but they are properly based on research data. [Bacon et al.] Personas embody essential behavioral patterns among target users. Using a friendly and approachable narrative format, they describe users’ key tasks, attitudes, motivations and workflows.

Personas help identify product opportunities and clarify use-related risks. The activities of design ethnography involve understanding people’s motivations and existing workflows. Personas embody those findings. Analyzing why people do things and how people do things can generate innovative solutions for ways that the newly-designed system can support personas’ goals more directly. Personas reveal when the new product can reduce or eliminate any frustrating or redundant steps in the user’s current workflow.

Rich, data-driven personas also facilitate communication and user-centered decision-making. They allow the product team to share a common understanding of target users. Team members can now reference a specific individual persona and ground their decisions in a shared understanding of who exactly is being served. There are no more arguments over what “the user” wants, because specific users are clearly understood by the whole team. Because realistic personas generate empathy, they also encourage team members to remain committed to delivering a high-quality, satisfying user experience.

Personas are also a powerful planning tool. Personas help product managers prioritize target users and control scope. The designated primary persona has needs that must be served entirely by the design solution, while secondary personas have additional needs that must be served in some area. The needs of supplemental personas, who are fully served by the solutions devised for primary and secondary personas, are not allowed to impact the design solutions. Personas also work seamlessly with a scenario-based approach to Interaction Design, which will be discussed in the following chapter.

EXAMPLE PERSONA

Dr. Helena Reardon Interventional CardiologistDr. Reardon performs a variety of surgical procedures every day starting at 7am. She sees her daily schedule when she arrives to the hospital and scrubs down outside the operating room. Most procedures are relatively routine surgical ablations and device implantations, but her case load of biventricular implants has been increasing. Biventricular implants can take hours to complete since placement of the left ventricular lead involves tricky intravenous navigation. She welcomed the introduction of RF telemetry to remove the barrier of the sterile field between herself and industry representatives, but she’s frustrated whenever telemetry is lost because it slows her down. Dr. Reardon’s goals include:

• Haveinformationatherfingertips• Trusthertools• Experiencenosurprises

This abbreviated persona description was developed for example

purposes only and is property of Devise LLC


Users are best understood in context

Sarah McDevitt Images this page

Case Study Example: User Research

At St. Jude Medical’s Cardiac Rhythm Management Division, the design team used ethnography to study the pacemaker and ICD implantation procedure for a new Pacing System Analyzer product that tests implanted lead functions before the medical device is secured in the body. The design team spent several days in the field, interviewing physicians and sales representatives and attending about a dozen implantation procedures.

After studying the actual work performed in operating rooms, the design team produced helpful documentation to share with the rest of the product team. Modeling the maintenance of the sterile field in a crowded workspace revealed challenges for the smooth transfer of

devices and information between people. Workflow variations were identified between pacemaker and ICD implants, as well as around the use of specialized tests and how test results were recorded.

Personas were created for the Sales Representative who usually operates the Pacing System Analyzer; the Implanting Physician and Physician’s Assistant who handle the surgical procedure; and also the Nurse who supports everybody else in the O.R. Identifying the Sales Representative as the primary persona clarified the target user’s needs. Recognizing the variety of personnel, tools and workflows involved in the implantation procedure let the product team identify and mitigate risks such as switching between medical systems.


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 Testing stages, the outputs of each design stage iteration generate solutions of increasing fidelity and correctness, always centered around the needs of the target user.

The core Interaction Design process moves iteratively through the stages of Ideation, Modeling and Testing

“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. ”


Project Phases

Viewed at a higher level, iterations of these three design stages unfold 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 presentation

Design activities can move quickly and seamlessly through multiple iterations of the core design stages at each phase of the project. For example, during the Design Framework phase of a project, design stages could move through an iterative flow such as:

IdeationModeling

IdeationModelingTesting

IdeationModelingTesting

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 scope and schedule. Each project phase could last between a few weeks and a few months, again depending on scope and schedule pressures. Because the core design process described here integrates with up-front development efforts such as requirements documentation, it does not add significant additional time or cost. What they do is reduce risk and eliminate guesswork throughout the project.

Successive iterations of the design process stages within each of the project phases deliver solutions of increasing fidelity and correctness leading towards implementation (waterfall model shown).


Architecting a HouseAn example from the field of architecture illustrates the importance of iterating design work across several phases. When conceiving a house, the architect begins with understanding its residents and locating the house’s foundation on the property. Then the architect defines the relationships between rooms as well as their principal features, and ensures that load-bearing walls are placed correctly. Finally, the architect addresses the finer features of the house,

Questions being answered include:

• For whom exactly is this house being built?

• Where should the house be situated on the property?

• How big will the dwelling be?

• What qualities of the house are most important to the client?


• How many bathrooms are needed?

• What’s the exact relationship between the kitchen and the dining room?

• Does the scale model reveal any feasibility or usability issues?

• Are the hallways wide enough to comply with safety codes?

PRODUCT CONCEPTIONDESIGN FRAMEWORK

DETAILED DESIGN


• What style faucets should be installed?

• What kind of material should cover the kitchen floor?

• What is the cost of a given material choice?

• Would the resident like a large bay window in the living room?

including its visual and tactile characteristics. At each phase, the architect is ideating, modeling and testing out ideas with increasing levels of fidelity, from paper sketches to scale models and perspective drawings. Changing the shape of the foundation late in the project would be a costly disaster. Throughout the project, the architect also collaborates with the client as well as people who will be charged to build and outfit the house.


5.1. PRODUCT 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: IdeationAn 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.

Product Conception: Modeling For Modeling initial product concepts, many Interaction Design practitioners employ a scenario-based methodology. Using the primary and secondary 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

Design process methods and outputs of Product Conception phase

PRODUCT CONCEPTION PHASE


the personas’ current world. Because Modeling focuses on solidifying concepts and scope, design outputs take low-fidelity forms such as written scenarios and whiteboard sketches.

Product Conception: Testing In the first Testing stage, any low-fidelity design outputs can be tested internally by reviewing Personas, scenarios and other models with a cross-disciplinary team. Team members can help identify requirement gaps or feasibility concerns with the proposed product vision. Models of existing workflows can be compared to the new usage scenarios to identify where new product concepts better mitigate risk. If any new risks are identified, an iteration back to Ideation ensues to ensure that no risk moves forward without appropriate mitigators in place.

Testing of concepts with real users also can be conducted during this phase. One type of testing is called Directional Testing, which involves presenting multiple visual concepts to users and soliciting their feedback on which direction the company should pursue. This testing is useful in the event that multiple product concepts are being considered or different visual brands are being evaluated. Like design research, this activity should be conducted in one-on-one sessions to minimize group-think.

Concept Testing is another helpful tool for this phase of a project. This activity involves seeking validation for the product scope from members of the target market, and can help identify the relative importance of product features. Focus groups and surveys can be used productively here; quantitative survey tools can validate customers’ feature priorities and provide statistically valid data that tends to resonate with upper management at medical systems companies.

Testing during the Product Conception phase involves figuring out what will make it fly

“The first project phase, Product Conception, will usually involve brainstorming, usage scenarios, 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.”


5.2. DESIGN FRAMEWORK PHASE

After the foundation is laid for the product concept, the Design Framework phase involves defining the overall user experience. Design Framework Modeling produces manifestations of the product features that are deemed in-scope, while Testing at this juncture validates design choices and identifies areas for further refinement.

Design Framework: IdeationInteraction Design practitioners can use the scaffolding of usage scenarios and persona goals to conceive the appropriate design framework. The ultimate user experience must deliver the right functionality in the right form at the right time. Ideation at this phase tends to be approached both visually and verbally, using a combination of analytical and creative tools to address how the system can best serve users needs. If this description sounds abstract, that’s because ideation here is a relatively intangible design stage — the artifacts that you can see are delivered through Modeling, next.

Design Framework: Modeling Scenarios are expanded and deepened through successive conceptual iterations. High-level usage scenarios are broken down into key path scenarios. On the visual side, initial whiteboard or pencil sketches become digital wireframes. Wireframes are digital representations of rough product functionality, with a low level of visual fidelity. Usually they will consist of black-and-white outlines of key system states.

Many designers will also proceed on to static mockups at this juncture. Mockups are higher-fidelity representations of the system, which integrate more visual polish into the product design. Storyboards can also bring scenarios and personas to life when a designer is handy with drawing figures or has access to life-size 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

PRINCIPLES AND PATTERNS

Interaction Design practitioners will refer to proven principles and patterns during the Modeling stage. Noteworthy principles and patterns include:

• Don’t make the user feel stupid. [Cooper 97] This principle may capture the moral essence of interaction design and is extraordinarily pertinent for medical systems used by physicians.

• Optimize for intermediates. [Cooper 45] Few users remain beginners and few users become experts — the majority of users exist somewhere in-between, and need be served with interaction mechanisms suited to their level of expertise.

• Global navigation. [Tidwell 66] Devote an appropriate portion of each interface to a set of controls that take the user to key sections of the application. This pattern gives control to users and provides reassuring consistency.

• Progress indicators. [Tidwell 149] Show the user how much progress is being made for any operation lasting longer than 2 seconds, even if the time estimate is imprecise. This pattern relieves user anxiety and makes people more patient.


for product families or exist as competitive standards within established industries. Some medical design frameworks, such as games that are intended to promote health or products aimed at engendering a healthy lifestyle, may also need to consider emotional affects such as playfulness and fun to ensure user engagement and patient compliance.

Design Framework: TestingAt this phase, Testing generally involves additional user research. As the product models gain fidelity, a qualitative user research method called Usability Testing can be applied to refine and validate proposed solutions. Usability testing is a way of measuring usability and user satisfaction by presenting potential and current users with some form of product model. These product models vary in resolution depending on the maturity of the project; at the Design Framework phase they will tend to comprise paper prototypes of the wireframes or static mockups but could involve an interactive prototype.

Usability Testing involves presenting product models to users in experimentally-controlled, one-on-one sessions. Such testing with real people can reveal a wealth of information about the design framework’s strengths and weaknesses. Usability Testing is a proven rapid and cost-effective research technique. Respected studies of usability testing show that sessions conducted with as few as five users can reveal 85% of a product’s total usability problems. [Nielsen]

Applied in an iterative fashion, multiple rounds of usability testing during the Design Framework phase can augment the design process. To summarize the results for team consumption, usability test reports will highlight users’ response patterns and identify areas of the product that could use further design refinement.

Design process methods and outputs for Design Framework phase

DESIGN FRAMEWORK PHASE

“The Design Framework phase involves defining the overall 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.”


5.3. DETAILED DESIGN PHASE

During this phase, typically the longest design phase 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: IdeationIdeation for detailed design is informed by the inputs from preceding Testing activities. Small interactions may require additional design attention. Ideation here can also be driven by formalization of the product’s visual language and 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 Framework: Testing Usability Testing activities can leverage interactive prototypes at this phase, if available. Interactive prototypes add richness and depth to the feature behaviors that can be tested with actual users. Depending on the prototype code’s closeness to the actual development language/environment, interactive prototypes can involve vetting product feasibility, too. Going to this length also tends to make the development team’s projected scope estimates more accurate.

When Testing shows an acceptable level of user satisfaction, the design process transitions into playing a supporting role for the implementation team.

Design process methods and outputs for the Detailed Design phase

DETAILED DESIGN PHASE

“During the Detailed Design phase, designers articulate product solutions with a realistic level of fidelity, iterating mockups and potentially interactive prototypes. When Testing shows an acceptable level of user satisfaction, the design process transitions into a supporting role for implementation.”


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 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 reports• 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.

Merlin PCS hardware platform

Initial “FastPath Summary” screen for the Identity® ADx pacemaker


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 research as design input for use case scenarios provides requirements authors with the right information to document the appropriate system and software requirements.

Scenarios support good documentation


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 and terminology of the target user population. Interaction Design thus helps to bridge the gap between the medical industry professional in the corporate office and the medical system user in the field.

Insights gleaned from user research and design thinking can also 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.

“Usage scenarios transition well to be an input for requirements documentation. Interaction Designers formally review requirements to help ensure defined features reflect the behaviors indicated by design research. Design documentation can also inform user manuals and marketing activities.”


Case Study Example: Documentation

At St. Jude Medical, the personas, scenarios and other models delivered during the design process for the Merlin PCS were leveraged for formal product requirement documents. Each requirements document began with one or more formal use case scenarios that reflected the routine workflow of the primary persona, and then branched into alternative and exception flows for the primary and any secondary personas. Interaction Design team members were also key participants in every formal review of requirements, helping keep implementation true to users’ needs.

Merlin PCS marketing brochure

Additionally, when the Merlin PCS was launched, the marketing team used the campaign slogan: “Designed by clinicians for clinicians”. This message resonated very positively with the target user population of pacer nurses whose daily needs had too often been relegated below those of physicians. The product’s ease of use, achieved through the application of iterative, user-centered Interaction Design processes, became a significant selling point for the new system. St. Jude Medical’s market position moved from a distant third to a strong second as a result.


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 people’s 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 of various departments, as shown in the diagram at left. This situation is especially true for medical systems development because the 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.

In any serious medical systems company, a centralized Interaction Design team will collaborate with many parts of the organization (other departments’ collaborations not depicted)


Due to the way that Interaction Design practitioners collaborate with many different departments, one of the more successful models for large organizations is to create a centralized consulting group. Members of a central Interaction Design group can work on multiple projects simultaneously, staffed according to the projects’ current stages in the development process. Such a group can naturally become a generalized Design department, housing Interaction Design as well as Industrial Design and/or Visual Design team members.

One useful service that an internal Design group can provide is training other team members in user research and usability testing. Techniques such as those employed with ethnography support good outcomes for any activity where medical industry professionals will be interacting with potential or current users and customers. Listening and interviewing skills that Interaction Design practitioners employ for research to establish rapport with users can be taught to others, and improved with practice.

Creating an Interaction Design group raises the issue of proper staffing. This factor is influenced by size of your organization. While highly-experienced Interaction Design generalists can seamlessly support user research, ideation, modeling and testing, many practitioners tend to specialize in certain areas such as user research or 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 to retain talent—the kind of people who finally understand your complex domain and technology, and know how to apply that understanding for successful medical system development.

To support the success of a Design department within a large organization, high-level executive support is crucial. A designated “design champion” can address the dynamics of how design impacts the practices of other departments; s/he can help to evangelize user research and design activities. This step could even involve appointing a Vice-President of User Experience or Chief Design Officer in order to fully legitimize the important effort of establishing user-centered approaches throughout the entire organization.

How can you get the most value from cross-disciplinary collaboration?

“Listening and collaboration are key Interaction Design tools for forging a shared team vision.”


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.

• Interaction Design applies at the front-end of product development, going beyond human factors and usability. It’s about defininginnovativeproductsolutionsthatsatisfycustomers—andsatisfiedcustomersmakeforsuccessfulcompanies.

• 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.

• InteractionDesignmethodsandoutputsofferbenefitsforrequirementsdocumentationanddevelopment efforts, as well as supporting marketing activities.

• Establishinganin-houseInteractionDesigngroupbenefitsthewholeorganization.EnsuretheDesigndepartmenthasastronginternal executive-level champion.

Dr. Helena Reardon Persona


9. referenCes

• Bacon, Elizabeth and Calde, Steve. “Death to Personas! Long Live Personas!”. <www.devise.com/further_reading>.

• Beyer, Hugh and Holzblatt, Karen. Contextual Design: Defining Customer-Centered Systems. Morgan Kauffman Publishers: San Francisco, 1998.

• Calde, Steve. “Design Research: Why You Need It“. <http://www.cooper.com/journal/2003/03/design_research_why_you_need_i.html#more>.

• Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration, Public Health Service, U.S. Department of Health and Human Services. “Human Factors Points to Consider for IDE Devices”. <http://www.fda.gov/cdrh/humfac/ide_hf.pdf>. January 1997.

• Cooper, Alan; Reimann, Robert; and Cronin, David. About Face: The Essentials of Interaction Design 3. Wiley Publishing, Inc: Indianapolis, IN, 2007. (First version published in 1995.)

• Cooper, Alan. The Inmates Are Running the Asylum. Macmillan Computer Publishing: Indianapolis, IN, 1999.

• Corporate. The Joint Task Force on Computing Curricula. “Computing curricula 2001.” Journal on Educational Resources in Computing (JERIC), v.1 n.3es, Fall 2001.

• Dray, Susan, et al. “Is ROI an Effective Approach for Persuading Decision-Makers of the Value of User-Centered Design?” CHI 2005 Panel, April 2-7, 2004, Portland, Oregon, USA. ACM 1-59593-002-07/05/0004.

• Federal Drug Administration (FDA), Institute of Medicine. “To Err is Human – Building a Safer Health System”. <http://www.fda.gov/cdrh/useerror>. November 1999.

• IEC 60601-1-6 “Medical Electrical Equipment - Part 1-6: General requirements for safety — Collateral Standard: Usability” Draft dated 2002-05-14.

• Kaye, Ron and Crowley, Jay. “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management: Identifying, Understanding and Addressing Use-Related Hazards.” Division of Device User Programs and Systems Analysis, Office of Device and Industry

Programs, Center for Devices and Radiological Health, U.S. Food & Drug Administration, Public Health Service, U.S. Department of Health and Human Services. <http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094461.pdf> July 2000.

• Moggridge, Bill. Designing Interactions. The MIT Press: Cambridge, Massachusetts, 2007.

• MSN Money. “Happy customers, good stocks”. <http://articles.moneycentral.msn.com/Investing/CompanyFocus/HappyCustomersGoodStocks.aspx>.

• Nadler, David A. “Managing Organizational Change: An Integrative Perspective”. Journal of Applied Behavioral Science. April 1981 vol. 17 no. 2 191-211.

• Nielsen, Jakob. “First Rule of Usability? Don’t Listen to Users”. <http://www.useit.com/alertbox/20010805.html>.

• Nielsen, Jakob. “Why You Only Need to Test with Five Users”. <http://www.useit.com/alertbox/20000319.html>.

• Saffer, Dan. Designing for Interaction: Creating Smart Applications and Clever Devices. New Riders: Berkeley CA, 2007.

• Sawyer, Dick, Officer of Health and Industry Programs, et al. “Do It By Design: An Introduction to Human Factors in Medical Devices.” Center for Devices and Radiological Health (CDRH), U.S. Food & Drug Administration, Public Health Service, U.S. Department of Health and Human Services. <http://www.fda.gov/cdrh/humfac/doitpdf.pdf>. December 1996.

• Tidwell, Jenifer. Designing Interfaces: Patterns for Effective Interaction Design. O’Reilly Media, Inc: Sebastopol, CA, 2005.

• Wasserman, Todd. “Thinking by Design”. <http://www.brandweek.com/bw/content_display/news-and-features/packaging-and-design/e3i397aa99d2932d77d688976026b8e533e?pn=1>.


ABOUT DEVISE

Devise Consulting provides digital product design consulting services, specializing in User Research, Interaction Design and UX Training. Liz can be reached at 503-347-4931 or email [email protected], or please feel free to connect on LinkedIn.

ABOUT THE AUTHOR

Elizabeth Bacon began her career in user experience design and research at the seminal consultancy Cooper in the late ‘90s. She then was the founding member of the Human Factors Design Engineering team at Fortune 100 medical device company St. Jude Medical, designing software systems such as the Merlin PCS which manage implantable cardiac rhythm management devices. After St. Jude Medical, she launched her own digital product design consultancy, Devise, and has worked with a range of companies to research customer needs and design innovative products. She moved into Product Management at Providence Health and Services in 2012, and founded the disruptive startup, Find Wellness, that year as well. Liz now juggles work as President of Find Wellness and Principal at Devise Consulting. She’s also proud to be a Director Emeritus of the Interaction Design Association, the world’s leading professional organization for user experience designers, as well as a graduate of Stanford University. When she’s not carrying the torch for interaction design to change the world, Liz might well be found indulging her passion for high-performance driving.

“Let’s Devise!”

http://www.linkedin.com/in/elizabethbacon