The Quest for the Truth in Medical Product Design

Jun 8, 2016

By Chris Ross, Principal at Mindflow Design

Growing up, my parents always told me to tell the truth. And in Boy Scouts, we recited the 12 points of the Scout Law weekly before every meeting. The first point is “Trustworthy.” The idea of truth or being truthful to promote trust is a foundational element for most of us. Being truthful gives us direction and reduces the risk of making a wrong decision because we can always rely on the truth.

I listened to one of our clients at a speaking engagement explain the “ah-ha” moment he experienced while working with us. With exuberant passion he said to the group, “MindFlow Design gets to the truth. You’ve got to get to the truth first”. What he meant was, above and beyond all the great design and engineering work, we established the right direction for his company as well as his product. We didn’t jump on board with his initial assumption but rather challenged it. The result: a breakthrough product plus an entire line of products, a new brand, and new business model.

When clients ask us to develop medical products, they come through our studio doors with one of three mindsets. Either they have a well-defined problem, think they have identified the problem, or already have a solution in mind. The second two mindsets are much more common and involve problem statements and solutions that have been based upon symptoms. Starting with a misdirected solution is a recipe for disaster. I hope your company is not one of them.

For example, a client asked us to redesign a product’s control panel because customers were complaining that it was hard to use. After watching multiple medical procedures, our researchers found that users were constantly turning away from patient tasks to fiddle with a temperature control dial. Over time, this became a subconscious activity and they weren’t even aware of their actions. The problem was not the user control panel; it was an inability of the electronics to keep a consistent, pre-set temperature throughout the procedure. The solution was to fix the thermostat, not the user controls.  Early seeker of truth Aristotle (at right) believed in knowledge through empirical observation and experience.

So how do you make sure you’ve identified the correct problem? How do you reduce the risk of misdirection? How do you get to the truth?

The answers to these questions are so important that we’ve dedicated the entire first phase of our MindFlow Design Guideway product development process to it. Our first phase begins with completing a thorough diagnosis and ends with a strategy ready for implementation. While I can’t share all of our intellectual property with you, I’ll give you enough insights to help you get closer to the truth.

I’ll make my case through the lens of a product development partner but your internal development team could apply the same methodology.

Nine times out of 10, our first meeting with a prospect ends with, “Can you send me a fixed price proposal for the entire project?” Think about that for a second. It sounds like they are asking for a free product development plan to guide their business from someone who knows hardly anything about their company’s very unique situation. If a doctor ordered a kidney transplant for someone who just explained how badly their side hurts, he’d be sued for malpractice and lose his license.

As crazy as it sounds, a free fixed-price plan is actually what some people hope to get. We learned in writing over 500 proposals in the past decade that everyone defines the term “proposal” differently, so we sought a better way to come out of the gate.

We’ve learned what prospects really want is a cost and time estimate, proof of a process and expertise that will make them successful, and confidence that our team can pull it off. We’ve replaced traditional proposal writing with something much better for clients and us alike. Our proposals now include a fixed price to complete a detailed diagnosis, a budgetary estimate for the rest of the project, and walk-throughs of similar past projects that illustrate our process and how we will work with them.

The Diagnosis

A thorough diagnosis of your company’s particular situation is a crucial first step, whether you are using an internal team or an outside product development partner. It all boils down to gathering the information that you already have, identifying and filling the gaps, and choosing a direction that supports your business goals.

This is typically where we see the assumptions start to surface. Too often, companies will latch onto an early assumption and proceed down the wrong path. It’s imperative to stay the course, complete this diagnostic research and get to the truth.

As we know, medical product design and development is complex and very difficult. The variables and sheer volume of information that apply to your project are endless. So how do you handle all of that information, some important and some not, when kicking off a new project? We start by gathering and categorizing all of the information and variables into these six topic areas:

Users – Who are all the people that will interact with your product? What are their physical and emotional needs and wants? It’s the hardest information of the six categories to gather and requires a very specific skill set that most technically minded companies do not have in-house.

Market – What are the trends? What are your competitors doing and how will you position your product and brand? Often medical devices are strategically launched and sold in international markets before entering the US market.

Regulatory – What are the regulatory requirements for your product? We recommend meeting with FDA consultants and other regulatory experts at the beginning of every project.

Company – What is your most important business goal? What are the specific project objectives that support that goal? What are the individual expectations for each member of the executive team? What does the brand require as an output of the project?

Technology – What is the underlying technology and IP? Should it be developed first, before investing in the rest of the product development process?

Manufacturing – What are the initial manufacturing assumptions? How many will you produce per year? What should be the cost to meet pricing expectations? What about materials, processes, geographies?

Two types of information fill these six buckets – the known and the unknown. The first is fairly easy to gather with what we call a subjective sweep. A few examples of this type of information are standards in your industry, team members’ past experiences, or already established requirements derived from effective research.

We have a proprietary method for quickly and efficiently extracting this information from our clients at the beginning of each project, then documenting and analyzing it. The two most important tools we employ are a comprehensive survey, and our proprietary GuideWay Discovery Workshop. This process should be quick, efficient, and effective, because nobody wants to pay for research that has already been completed or information already in-house. Knowing what to ask for and how to ask are critical for this technique to be effective.

Design Research

The gaps that emerge during the subjective sweep usually require additional design research. In my experience, that research often leads to the pot of gold at the end of the rainbow, or the “ah-ha” moment. Typically, we discover new opportunities or constraints that heavily influence the direction of the project. The gaps can be in any of the six areas but we see them most in the user needs and technology invention categories.

An example: recently we were observing and benchmarking the way in which veterinarians used their portable digital x-ray system on horses in a barn. We noted that vets all knelt on the ground or hunched over awkwardly while interacting with their x-ray systems. Over the past 25 years, our client and the entire industry had accepted this as the norm. We recommended configuring the next generation system for vet use while standing comfortably. That breakthrough contributed to a market buzz that produced surging sales.

The amount and type of diagnostic design research you should conduct directly correlates to the amount of risk you are willing to accept. Medical device startups conduct less research than industry giants because of capital limitations but they also have less to lose in the risk department. Smaller companies compensate, however, by being more agile and able to pivot if they find themselves veering off course.

Developing a Winning Strategy

A winning design strategy can only be developed after a comprehensive diagnosis of the problem. This includes a detailed project plan, product requirements document, and a design brief approved by the executive team. We’ve formalized our process by requiring a Strategy Design Review to ensure all stakeholders are informed and agree with the direction before we proceed.

You’re probably familiar with a project plan and product requirements document, but might be asking, “What’s a design brief?” A design brief bridges the gap between strategy and implementation. It prescribes a direction (not solutions) to the design team based upon the diagnostic research and agreements made by the executive leadership. In most cases it uses images and illustrations rather than words to prescribe direction.

We kicked off a new project and the executive team was adamant that its portable medical device be “rugged.” Probing further, we learned that everyone, including members of our team, had a different idea of what being rugged meant. The technically minded folks launched into a discussion on materials and others into making it “look rugged”. How could our team begin designing and how could our client ultimately judge the “ruggedness” of our design solutions? We needed a common definition of rugged as it applied to this particular project.

We broke down “rugged” into three words: form, materials and structure. Then we collected a number of different images that we believed visually represented each of those words in the project context. After presenting a few different “mood-boards” to the executive team, everyone agreed on a single definition.

A pitfall to avoid is thinking that a product requirements document and binders full of research alone will successfully direct your project. Your design team needs visuals that inform and inspire them, not words that tell them what to do. A good strategy enables creative interpretation pushed in the right direction.

Commit to Finding the Truth

The truth in product design is often elusive. It hides out of sight, waiting to be discovered. One thing we tell clients is that if you employ the correct process, you will find the truth. The converse is also true. If you employ the wrong process, go by your gut or skip a few steps in a good process, you do so at your peril.

Originally posted on the Mindflow Design blog here and re-produced with author’s permission