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January 30, 2017
By: Steve Maylish, Fusion Biotec, and Scott Hutchinson, StoneCreek Capital
Chief Commercial Officer, Fusion Biote
In the past (and, to a large degree, today), medical device companies focused on selling products to healthcare providers and payers. However, as healthcare moves away from a reactionary, fee-based care model to health and wellness or value-based models, more focus is now on the consumer/patient. Payers are realizing that reimbursement for fees, tests, and visits add cost to an already overburdened system. Over time, prevention is less expensive than treating an acute or chronic condition. This has led payers to reimburse for better patient care and deny payment or penalize for hospital-acquired conditions. In addition, many medical device users today consider themselves consumers, not patients. In 2017, the emphasis will continue to shift from provider-focused to patient-focused healthcare. No matter what happens to the Affordable Care Act, the current trend is toward consumer choice (health insurance competition), consumer empowerment (health savings accounts), and consumer wellness. Today more than ever, digital healthcare, the Internet of Things, value-based care, and healthcare reform are converging to drive the consumerization of healthcare. What improves patient outcomes and adds value? Does a smartphone application really change consumer habits? Can hospital readmission rates be impacted or infection rates reduced? As the cost burden shifts, consumers are enjoying more focus while healthcare providers and devices are subject to more scrutiny. As this trend continues, medical device designers will need to shift their focus as well. Unfortunately, patient outcome data is costly to generate and can sometimes require years of clinical work after a product launches. Determining product value and likelihood of improved outcomes early can be invaluable. Incorporating this knowledge into the innovation phase can ensure product acceptance. But today, most companies try to accomplish this by learning more about the customer, rather than the “job” that needs to be done. Clayton Christensen, best-selling author of “The Innovator’s Dilemma,” just released a new book titled, “Competing Against Luck” as a resource to help improve product design. To innovate, Christensen teaches that one must first discover what job consumers are hiring a product to do. This is then translated into a job specification: “What do I need in my new product, so that it does the consumer’s job well?” And finally, a company’s capabilities must be integrated in order to “nail the job consistently.” For medical products, the job of improving patient outcomes translates as the immediate result from a product or service and long-term benefit. In short, how well does the device do the intended job? As consumers take more control of their health, existing models are bound to change. For all Theranos and Elizabeth Holmes did wrong, they did have their business model right. What they didn’t have was technology to back up their claims. Theranos states on its website, “We are developing technologies that will enable us to make it possible for more people, in more places, to get the laboratory tests they need.” This shift to a consumer-centric model (i.e., small blood draw, convenient access at a local retail clinic, transparent online pricing, and no doctor visit) is at the heart of the company’s business model—and it is not alone in this pursuit. More companies are realizing that healthcare is shifting toward consumers, a classic case of “disruptive innovation.” As proof, in 2016, digital healthcare investment reached an all-time high of more than $6.5 billion. So how does a medical company create consumer-centric, disruptive innovation? It’s exciting to improve one’s quality of life, but as Theranos knows, there are risks involved in product innovation and disrupting existing models. Medical device development is a highly technical and costly undertaking. Marketing and development teams understand how data and analytics can drive decision-making. One of the unfortunate ideas resulting from data and customer analytics, however, is that to develop new products, we need to learn more “about” the customer. This need for customer or user data is more acute in medical design, where the product is submitted for approval to the U.S. Food and Drug Administration (FDA). In the submission, the FDA requires usability engineering reports. Usability engineering requires a focus on user profiles, use environment, and user interface. The idea is to identify use-related hazards, mitigate them, and validate safety and effectiveness. This human factors validation testing analyzes how the user interacts with the newly designed product and looks to reduce user-related errors. More customer data tells designers more about the customer, but very little about the actual job customers want done. It turns out that one of the best strategies for creating new products is a process called “jobs to be done.” This method of creating new and disruptive products was developed by Christensen, a professor at the Harvard Business School (HBS). Christensen observes that there are four reasons why customer information is a misguided path to innovation:
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