Guest Column | February 19, 2016

5 Keys To Designing Medical Devices For Life Beyond Clinical Trials


By Mikkel Brok-Kristensen, ReD Associates

Life sciences should be in the business of making products for life, but throughout my decades of work in healthcare I have seen the same situation again and again. In the clinical trial setting, a product may show promising improvements, but those improvements are negated if the real-life value experienced by product users is not improved, as well.  

What happens when a product fails to deliver in the real world is no secret: The patient forges ahead and returns to life’s activities, minimizing use of the product or stopping its use altogether, thus bringing on new health problems and earning the patient a “noncompliant” label from their healthcare practitioner. Or, even worse, the patient disengages from life, accepting limitations imposed by the very product that was supposed to restore their ability to live life.

Case Study 1: Shortsighted Design

Dan (not the patient’s real name) is a cancer survivor in his sixties. After months of chemo and radiation therapy, followed by surgery, his cancer finally is in remission. This is the moment Dan dreamed about through the most challenging phases of his battle with cancer.

We might assume that Dan’s return home would begin a celebratory period, a time of a life reclaimed, or begun anew. The reality, however, is different. Dan now lives with a voice prosthesis — a one-way valve inserted in a stoma on the front of his neck, a common result of the cancer treatment he has undergone. Breathing directly through the neck, he coughs a lot, gets exhausted easily, and finds talking difficult.

Dan may be cured of cancer, but the residual effects of his treatment leave him feeling far from well, and completely dependent on his new aide: The voice prosthesis and an additional filter, as well as a heat and moisture exchanger, that he attaches to the top of the prosthesis with an adhesive. The device allows him to speak by closing off the air flow through the stoma. The product fared well in clinical trials, clearly delivering on its promise of enabling a safe and efficient occlusion of air flow through the stoma. “It’s my companion. It stays with me all day, it goes everywhere I go,” he says.

But product is not delivering in real life. The daily hassle is huge, making users’ experience one of heavy compromise: The device makes it difficult to sleep or exercise, and it turns every social interaction into a conversation with you as a sick person. In other words, it causes many of the countless mundane things that are life to completely change. As soon as people like Dan try to return to everyday life, it becomes apparent that the products are simply not good enough.  

Why does this happen with otherwise-promising medical devices? In the laboratory tests and clinical trials, focus is on medical efficacy and safety, as well as comparisons against competing products on already established parameters. Patients are supported by a bevy of medical professionals in a way that you would never find in the real world. In some cases, the drug or medical device is tested in situations with little resemblance to real life conditions.

Whether it is the mother of two who wants to eat out with her family, the fitness buff who wants to work out, or the former construction worker who — after only a few weeks of training — is now conducting dialysis at home, patients need solutions for the complex and context-rich environments of their actual, everyday lives.

Case Study 2: Design That Considers “Life” Lessons

Forward-thinking companies are designing products that improve on ture-to-life contexts and situations. Consider, for example, the case of intermittent catheters from medical device manufacturer Coloplast. The market has been filled with catheters — long, flexible straws inserted through the urethra to meet the bladder, allowing urine to flow — designed for use in a hospital or home environment. But patients were clamoring for a device they could take out into the world with them.

Patients struggling with urine retention (the inability to completely empty their bladders) encounter some of their biggest challenges in public environments. Coloplast recognized this and created a catheter small enough to fit inside a pocket or a clutch purse. Designed with the aesthetic principles of the cosmetics industry, the catheter’s shape, size, and even color scheme call to mind a tube of lipstick — inconspicuous enough to avoid attracting unwanted attention.  

Rethinking the device in this way helped to dramatically improve the flexibility of its use, and enabled patients to more easily comply with using the catheter up to five times daily, as prescribed. As a result, both patients and health care practitioners have responded positively to the product, and it has become a major growth driver for Coloplast.

5 Keys To Designing For “Life”

So what is it that companies like Coloplast do differently that helps their offerings succeed in real life? Their R&D and innovation process is perspective-driven and built around some variation of the following five key elements: 

  1. Dare to re-frame the question. Re-frame a business challenge as a social – and often much broader – question. This helps to grasp the challenge’s complexity, but in a focused way, avoiding the risk of over-simplifying the user’s needs and missing the mark in real life.
  2. Look at the full ecology. Seek an understanding that goes beyond the doctor and the patient. A broader perspective might, for example, include the role of the patient’s family, the office clerks in the hospital, or the insurance agency. Dedicating resources to immersive observation allows you to identify all the key stakeholders, and to truly understand their interdependent needs.
  3. Listen and observe… a lot. Go beyond market reports, surveys, and interviews. Build customer insight by systematically immersing yourself in the rich and contextual world of users through extensive participant observation. The collected qualitative data brings an unparalleled depth of understanding.
  4. Break free of hypotheses. Allow for a genuinely fresh start by breaking away from existing hypotheses. Subscribe to an open, iterative approach to user research that is built around an interpretive process. Equal parts analytical and creative, such processes make it possible for radically new ideas to emerge.
  5. Develop a clear perspective to drive innovation. Identify the bigger picture first, and (only) then turn to technology to solve specific problems. To give a clear direction to R&D efforts, it is helpful to use customer insight to build an overall perspective on the area in question first. Use that insight to inform both the overall innovation intent and all the individual innovation projects. This helps avoid solving for marginal issues, and creates a shared purpose around the ultimate goal of improving patients’ everyday experiences in a meaningful way.

Walk A Mile In The User’s Shoes

More life sciences companies should be moving in this direction — building their R&D on the unmet needs of patients in real world contexts. Products’ future successes will depend more and more on their ability to deliver on the road, in the restaurant, or, for people like Dan, in the fitness center. Products that will succeed are products designed for more than the clinical trial; These are products designed for real life.

About The Author

Mikkel Brok-Kristensen is a partner at ReD Associates, a strategy and innovation consulting firm based in the human sciences. For the last ten years, he has worked within health care, primarily advising medTech and pharma clients on new product development and go-to-market.