When (and How) to Integrate Usability into Your Medical Product Development

 In Design Strategy, Medical Product Design

Human factors and usability activities play a vital role in medical product development. Not only do they help provide insight for development, they are also closely tied to risk management and regulatory requirements.

We often encounter medical device manufacturers that need guidance to understand how usability is supposed to integrate with the development process, not to mention how and when to schedule specific activities within their timeline. Often, the lack of early product definition can lead to confusion about what is required from a regulatory standpoint.

We also see projects that are so far along in the development process that instead of working on manufacturing details, substantial resources are being allocated to play usability catch-up. This is particularly difficult as the great majority of usability work should be done alongside the development process, not after it. In fact, usability activities should guide the development process, providing insight and identifying hazards.

And then there are the companies who are departmentally siloed. Usability teams are being utilized for pass/fail testing, either brought in too little or too late to foster insightful and focused development.

MPE (Formerly Mindflow Design) Medical Product Development Diagnostics

Whether you need a better understanding of usability requirements, the usability tools and processes to get your project back on track, or to valuably integrate usability into your development process early on – you must evaluate where your project is today and define where it should be at its successful conclusion.

At MPE (Formerly Mindflow Design) , we kick off projects with diagnostic workshops that visualize where you are in the process. This can be done at any stage of development, for specific categories of development or for the entire project as a whole. Should our scope of work lie only within usability, we would start with our usability diagnostic. For full scope design and development, we lay the foundation of the project by conducting our entire range of diagnostic workshops.

We then build on the completed diagnostics by performing a gap analysis, identifying areas for improvement and those missing all together. In this case, the usability diagnostic and gap analysis together inform the human factors plan; the specific path to your usability goals.

MPE’s (Formerly Mindflow Design) Human Factors & Usability Diagnostic for Medical Devices

Within our human factors and usability diagnostic, we conduct three discovery activities to help determine your project oriented strengths and weaknesses.

1. Product Demonstration and Workflow Analysis

We observe a subject matter expert demonstrate in detail how your device is used, without interruption. This can be done with your product that is currently on the market or with prototypes in development. The focus is to capture the expert’s perspective on how the device is used. Often, this leads to valuable conversations from different corners of the company about the intended use of the product itself.

After the product demonstration we conduct a workflow analysis, diving into the details of the use case. Here, we can review the workflow and tasks the subject matter expert has previously showcased. From this detailed exploration, we give definition to each task, documenting the strengths to build on and the weaknesses to build up.

2. Use Specification Diagnosis

Our second activity in the human factors and usability diagnostic is to determine the level of completeness of your use specification. It is a primary input to a product requirements document that drives your entire development project. An inadequate use specification usually indicates inaccurate product requirements. An early use specification diagnosis can prevent misdirection and keep your project on track.

At a bare minimum, the usability standard IEC 62366-1:2015 requires your use specification to include:

  1. Intended medical indication

  2. Intended patient population

  3. Intended part of the body or type of tissue applied to or interacted with

  4. Intended user profiles

  5. Intended use environment

  6. Operating principle

But, there’s a lot more to it than having a document with a paragraph or two about each of these six sections. Our detailed diagnostic reveals if your use specification is adequate and ultimately if your project is on track.

3. Mapping Your Human Factors Engineering Plan

The Human Factors Plan is your high-level playbook on how users will be included in your design process. It describes the iterative human factors engineering process that starts with user research, proceeds with rounds of formative user evaluations, and ends with validation. Proper execution of the plan is paramount in ensuring the safety of those who interact with your product. It does this by identifying and eliminating use errors.

Because the human factors plan is so important, our third diagnostic activity actually starts before we even conduct the diagnostic. We send surveys to key stakeholders in your company to get their perspective on what usability activities and related documentation have been completed. The actual diagnostic is a workshop-style review of the responses to the survey. This is done not only to define usability requirements, but to align conflicting views of project stakeholders. In our experience, stakeholder alignment is crucial to writing the human factors plan, and by extension, project success.

Our deep expertise in human factors and usability allows us to diagnose the quality of your human factors plan no matter where you are in development.

Gap Analysis & Planning

So, we’ve jumped in and taken a flashlight to all the dark corners of the project. Our gap analysis brings together our recommendations from all three diagnostic activities. We compile the many small indicators for project readiness and calculate a readiness score. This gives a high level understanding of how much work needs to be done before moving on with development. We then dive in and review each category in detail, illuminating particular strengths and deficiencies.

Upon completion of this diagnostic assessment, we can either begin to build your Human Factors Plan or modify your existing one.

There is a substantial amount of work and expertise that goes into making a product that empowers users, is safe, and improves patient outcomes — all while simultaneously meeting human factors related regulatory requirements.


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