It will be different next time. Much different, hopefully.
 
Future pandemics are unlikely to resemble the disjointed patchwork of COVID-19 mitigation efforts implemented worldwide by lawmakers and health officials. Instead, they possibly will involve more coordinated responses and widespread testing, as well as technological innovations inspired by design thinking.
 
Such thinking could result in redesigned public spaces that double as treatment areas during an outbreak and airports with more security screening lanes. Hospitals are likely to rethink conventional schematics too, potentially employing such pandemic-busting features as negative pressure zones, special patient evaluation areas, telehealth centers, and flexible-use rooms (i.e., those easily modified between acute care and ICU).
 
With the COVID-19 threat unlikely to abate in the fore- seeable future, design thinking could potentially become a powerful tool in helping to better manage and control forthcoming pandemics. The approach is already being used to improve healthcare equity and spawn creative solutions to medicine’s most pressing dilemmas.
 
MPO’s January/February feature, “Inventive Interaction,” explores the various forces at play in medtech R&D. David Schechter, president of Meddux Development Corporation, was among the various experts interviewed for the story. His full input is provided in the following Q&A.
 
Michael Barbella: Where are companies spending their research dollars now—on incremental improvements to existing devices, or game-changing innovation?
David Schechter:Large companies are much more likely to focus internal R&D on derivative products and incremental improvements in established markets. Large companies have worked hard to gain significant market share and to develop an installed base of loyal customers. Game-changing innovation is not only risky but it can be costly to the established business and to the existing customer base. Startup companies are conversely tasked with creating new markets and demonstrating that providers and payers are willing to adopt and pay for game-changing and innovative new therapies and treatments. Once early market acceptance and clinical data are established, large companies have the resources and channel control to come in and fully develop the market.
If we look at large-scale trends in medical devices, there is a shift towards smart devices and the need to aggregate and analyze significant amounts of data more efficiently. With this access to data there is a paradigm shift where individual patients will be required to take more ownership of their own care. This will change how medical devices are designed, developed, and delivered to the patient. This dynamic is certainly apparent in diagnostics and consumer health, but there are also significant trends towards smart devices in areas such as interventional devices, minimally invasive surgical devices, advanced endoscopy, and active implants.
 
Barbella: How is value-based healthcare shaping the kinds of medical devices/technology being developed?
Schechter: Too often we are led to believe product innovation is synonymous with technological advancement. Technologies are enablers of innovation, but they are not one and the same. Essentially, technology provides the building blocks that we can assemble to solve real-world problems. From the perspective of value-based healthcare, new product innovations must apply technologies in a way that translates into increases in productivity, increased efficiency, avoidance of costly complications, or the ability to economically treat patients that we couldn’t otherwise treat. Too often we are enamored with new technologies and then are on a quest to find where they could be applied and what the expressed the benefits might be. With value-based healthcare, we must analyze the delivery of patient care as a business process and find solutions to optimize the inefficiencies in the process. We need to move away from the focus on the “device” and think more holistically across the entire patient-care spectrum and start to think procedurally. Economic drivers behind value-based medicine, however, cannot be the only factors to consider—we must also continue to strive to make innovative gains towards safer, more usable, more reliable, more consistent, and more clinically efficacious devices and treatments. Innovation is an imperative, and in most cases it is discontinuous. In most cases, economic value is only realized once technologies are matured and the product is delivered at scale.
 
Barbella: Please discuss the importance of university/academic partnerships in developing cutting-edge medical devices.
Schechter: University-based research exists to expand our fundamental understanding and knowledge in emerging areas of science and technology. Historically, most significant technological breakthroughs have been derived from academic or government- sponsored research. However, in most cases the academic environment is not capable of translating technology from research to viable commercial applications. This is most likely because innovation must start from understanding the critical need and problem and then identify appropriate technological solutions, and not vice versa. It is very difficult to start with a technology and then search for a problem to solve. University and academic partnerships are best served when potential applications of state-of-the-art technologies have been identified, but further development and refinement is necessary to translate the technology to a commercially viable solution for the specific application.
 
Barbella: Are startups better suited than their mid-size or large OEM cohorts to develop medical technology that addresses value-based healthcare solutions? If so, how? (Or, if not, why not?)
Schechter: The answer is twofold. Large OEMs are more likely to have the ability to go after and own an entire procedure and, more broadly, the entire patient experience from start to finish, giving them the control required to optimize total value delivered to patients, providers, and payers. At the same time, large OEMs are slow to enact change and react to changes in market dynamics. Startups are more likely to have the ability to react quickly and can bring disruptive innovations into play that change how patient care is delivered. It is critical however to focus broadly on market development rather than singularly on product development. It is essential to start with a clear understanding on how new innovations can bring value in terms of productivity, efficiency, cost-avoidance, or access to patients they we could not otherwise easily treat.
 
Barbella: Can a company effective tackle a healthcare need/problem and devise a solution based on its own internal R&D? Please explain.
Schechter: It depends. Internal R&D teams tend to be built around expertise in specific technology areas. In many cases, and specifically if you are thinking along the lines of delivering a value-based solution across an entire procedure or patient experience, a broad approach to enabling technologies is required. In short, the expertise of existing internal R&D teams may be too narrow. Many companies may then be challenged with building an entirely new area of expertise with their R&D organization or accessing critical technology knowledge gaps through strategic partnerships and development partners.
 
 
Barbella: How can companies “innovate the process of innovation” to achieve more transformational products through R&D?
Schechter: We have all heard a lot about “Design Thinking” methodologies that require us to better understand the user experience and empathize with the user. No doubt this is essential, but there are several common pitfalls that we tend to fall into when we try to innovate. We tend to over-focus on technological solutions and features, and it is typical to fundamentally underestimate the problem we are trying to solve. Technologies and features are shiny objects that may, in fact, add only limited benefits to select users—but they also significantly increase complexity and costs. We could almost always spend more time and energy up front to better understand the problem we are trying to solve. This allows us to drive innovation efforts towards holistic solutions that can broadly solve user needs. We should do this with an approach that helps us better understand the entire procedure and workflow, and also one that has less emphasis on a single-product solution. Our goal is to create a solution that is desirable (users), feasible (engineering), and viable (business). Which means that we need to assess not only user needs, but balance technical risk and whether the value delivered to customers is justified by the business case.
 
 
Barbella: How will AI, big data, and digital health affect the R&D process going forward?
Schechter: We are seeing an exponential growth in the amount of data and analytics we have about our individual health. Patients will have access to better and more specific data and in some cases may be more empowered to monitor and maintain their own health or disease state. This is a paradigm shift where data analytics, decision algorithms, and devices must be designed with a new set of users in mind (end-patients and not trained clinicians). It is also important to recognize that the vast majority of our current healthcare epidemics (obesity, diabetes, heart disease, cancer) result from behavioral and lifestyle choices. Will access to data through AI, big data, and digital health be effective enough for patients to enact real change?
 
 
Barbella: What is driving the need to outsource medtech R&D? Does the R&D process even need to be outsourced?
Schechter: Outsourcing specific aspects of R&D is a critical strategy that can shorten product development lead times and improve capital efficiency. The primary reason to outsource aspects of your product development program is to access experience and expertise that is not readily available within your internal teams. It is too costly to reinvent the wheel and learn every step of the way. You should engage a partner that is able to bring significant experience and technical expertise relating to your specific program. Outsourcing aspects of your product development program can also result in improved capital efficiency. This allows you to turn fixed costs into variable costs, effectively allowing you to throttle resources as necessary depending on the stage of development and prioritization of product development portfolios within a company.