A Way Forward for Medical Device Innovation

By Ty Hagler

About a year ago, we wrote a piece on the contrasts between innovation in the consumer products space versus the world of medical devices—contrasts defined by marketplace driven frameworks and their associated priorities.

Just a few weeks ago, a dear friend sent an informative piece that gave me pause for a re-think, or at least some new thinking about these two markets from a different angle.  In a Q+A session, Stuart Karten, a California-based industrial designer and juror for the Medical Design Excellence Awards, talks about the intersection of consumer products and medical design.  Karten correctly documents the power of the first impression, since consumers often inform their buying choices with that powerful first interaction with a product.

The medical device world faces a multi-pronged challenge in terms of form and function.  Companies must please so many stakeholders—patients, physicians, third-party payers like private insurers and government agencies, not to mention regulators!  You have to please the often disparate needs of these individual sets, while managing to have a unified product presence.

It seems that the medical device space could take many great ideas and best practices in product development from the world of consumer technology, in particular, especially in light of the fact that a more personalized medical experience is an emerging demand from the marketplace.  For example, many consumers want to be able to consult with their physicians via telephone or email on medication choices for chronic conditions.  Often, physicians need diagnostic data in order to make decisions informed from medical testing as well as qualitative data received from the patient’s description of his condition.

The infrastructure, phone and email, is already in place to connect these needs.  Numerous diagnostic devices are available for personal use at home, and we have the ability to bring devices together through ubiquitous computers, secure cloud-server storage, and wireless broadband and internet connectivity.  The intersection of these technologies will be defined by each company’s approach to the challenge of integrating hardware and software.  There are two successful models in the world for consumer devices—Apple and Google.

As Karten mentions in the Q+A piece, the iPad is an iconic example of a majestic interface.  This is critical to the consumer electronics experience.  What Apple also gets right is taking command of both sides of the hardware/software equation.  Not only is the iPad itself disruptive in terms of UI, the hammer blow to Apple competitors comes from the iTunes and App Store experience.

Apple has created a sleek, seamless, integrated hardware/software experience articulated through the iOS operating system and iTunes for interacting with music, movies, apps and other media content.  With an Apple device, you’re not just turning on a smart phone, tablet, or PC—you’re stepping into Apple’s world of thoughtful packaging, easy start-up, and you’re never more than 2-3 clicks from accomplishing anything.  It’s elegant simplicity at its finest.

Google offers another template for device companies that may not have the vertical integration to pull off both an optimal device experience and the software to drive it to a greater user experience.  With the Android operating system, Google has achieved market leadership in the smartphone market, outpacing Apple, and making a nice challenge in tablets. While they have done some periodic experimenting with homegrown handsets, the company has focused on partnering with external experts in the hardware space, such as Samsung and HTC.

While any kind of electronic device can fall prey to over-engineering, it’s important to remember that smart phones and blood sugar monitors both need an appropriate measure of design to balance the user experience.  It’s the designer’s job, and it’s right in his wheelhouse, to distill incredibly complex mechanisms into what each user needs from the device in terms of his or her individual experience.  The new Chromebook is an example of a unique product resulting from an effective design process.  The secret sauce comes in when designers squarely hit the needs of both average and power users. Apple achieves this as well as any company.

In the world of software, it’s easy to create a bloated, over-utilized experience.  Microsoft Windows, for example,  makes a lot of trouble available to the average Joe’s fingertips—one click of the wrong icon and Joe will be sorry for hours and days to come.  Whether companies develop internally or leverage external partnerships, designers need to resist the urge to do too much.  Again, design and development should achieve a balance and measure compatible with the needs of users.

One of our clients, Mustard Tree Instruments (MTI), is one of the best examples of this marriage of hardware and software.  Verifier TrueTest, one of MTI’s devices, measures the chemical composition of pills and capsules produced by manufacturing.  The genius of MTI lies in how the software platform articulates the test results.  Competitor products display data in a way that only a Ph.D. could read with any level of coherence.  In contrast, MTI made the user interface a core selling point by communicating data through friendly graphics with high accuracy.  The engineering power in their products yield a accurate and robust scientific testing experience, while the design displays actionable information to anyone who needs to make real-time decisions on a manufacturing floor.  This is how MTI’s products combine the elements of design and engineering with a wonderful balance.

There are many pages that medical device companies can rip from the consumer electronics playbook.  Obviously there are limits.  No one dies from an iPod failure. Therefore, while engineering needs a balance with industrial design, certain requirements cannot be compromised.  These engineering requirements are defined as “Design Inputs” by the regulators, but a case can be made that a greater commitment to user experience could improve both patient compliance and reduce use errors.

In the past, US medical device regulations attempted to address the need for proper industrial design by requiring companies to perform a risk analysis.  The most popular tool is called a Design Failure Mode and Effects Analysis (dFMEA).  More recently, the US FDA has acknowledged the need greater emphasis on industrial design by adding a new requirement for human factors. The new human factors requirements for medical devices will be the subject of a future guest blog.

Ty Hagler

Trig, 510 Meadowmont Village Circle, Chapel Hill, NC, 27517, usa