Medtech R&D Must Address Outcomes in Value-Based Care

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. Scott Larson, chief technology officer at TE Connectivity., 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?
Scott Larson: Both. Historically we’ve been more customer led and are now increasing our own investment to bolster innovation. This allows us to improve the partnerships with our customers by being proactive and offering them innovative solutions. We partner with customers for small incremental innovations, for example, a simple improvement in mechanical functionality. That same customer could also have a partnership need for the development of a future generation device to encompass multiple technologies, a potential game-changer device.
As CTO, I manage the technology roadmaps for TE Connectivity’s Medical Business. This framework defines both our short- and long-term view of innovation as mentioned above. For example, we may be innovating today around enhancing the steering performance of a typical catheter and, in parallel, working on a similar solution but in the context of adopting that device for a robotic approach.
 
Barbella: How is value-based healthcare shaping the kinds of medical devices/technology being developed?
Larson: Looking at device development through the lens of value-based healthcare has certainly shaped how our customers approach innovation today. If I think back 10 years, clinical requirements were the cornerstone of any new device development program—how do we meet the physician need? Now we have rounded out that fundamental development step to ask—how do we meet both the physician need and deliver a more efficient outcome? That question shapes thinking around innovation pipelines and priorities.
 
Barbella: Please discuss the importance of university/academic partnerships in developing cutting-edge medical devices.
Larson: Many universities and academic programs focus on the foundational research—solving the big questions that push the boundaries of medicine. It is important to TE Connectivity that we have active partnerships with these forward-thinking groups. For example, we are long standing partners of the BioInnovate program, affiliated with Stanford’s BioDesign program, where we work with their Fellows to build insights into evolving clinical thinking and its real-life application. In turn, these insights inform and enrich our own technology roadmaps. It is how we translate academic thinking to technical solutions for our customers.
 
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?)
Larson: This used to be the case, but many of the larger OEMs now understand that value-based healthcare is here to stay and are developing products with this in mind. The total patient experience must be considered—that means a high performing device at an affordable cost. Overall cost pressure drives lower selling prices which, in turn drives the need to lower product costs. Designing for cost as well as performance is a significant part of product innovation.
 
Barbella: Can a company effective tackle a healthcare need/problem and devise a solution based on its own internal R&D? Please explain.
Larson: Yes, I think this is possible. For example, when you think about device-based treatments for ischemic stroke, time is life, every second counts. Time to treat is often the difference between a patient with long term and expensive medical needs or a patient with fully restored mobility and lower cost of care. So now we ask the question, how can we innovate to dramatically decrease the time from establishing vascular access to delivering a restorative treatment? Then we start to think about low-profile catheters or tiny microcatheters that are enhanced by steering technologies to navigate into and through the brain network faster than a traditional catheter. Then we layer onto that the idea of an enhanced or smart catheter that can perhaps visualize and take real time measurements within the brain arteries. With all of this in mind, we also must deliver devices that are cost effective and simple to use. Bringing all of these innovations together enables a device that is more accurate and precise in use. Time to treat falls and in that manner, we have potentially addressed the core healthcare need/problem in a way that is meaningful for the physician and patient.
 
Barbella: How can companies “innovate the process of innovation” to achieve more transformational products through R&D?
Larson: Market demands, quality, performance and speed to market have been the cornerstones of innovation and product development. Now there are additional aspects of innovation that must be considered. Some of these include product cost, ease of use and manufacturability. Many companies are considering the manufacturing process early in the product development cycle. This reduces overall product cost, reduces the time to market due to ease of transfer into operations and ensures predictability of supply. Lean behavior has also moved from operations into product development and the way we innovate. With our engineers being aware of inefficiencies, or waste, they are able to propose new and better ways of doing things.
 
Barbella: How will AI, big data, and digital health affect the R&D process going forward?
Larson: I think that the days of developing devices without thinking about the digital continuum are fading into engineering history for our industry. TE Connectivity is all about creating a future where our innovations touch lives and connect the world. The opportunities to do this in healthcare are immense but there is a journey ahead. For example, how do we take a basic surgical or interventional device beyond simple mechanical function so that it is providing data about the patient? At TE, we are innovating to solve questions like these. For example, we recently brought a new innovation to market named VERSIO – a specialized connector for high density signal and power transmission in a low-profile catheter. Over a 1-inch diameter we can accommodate 272 contact positions for analog, digital and fibre optic data. The potential of such innovations to gather data in-vivo is immense. We are also integrating sensors directly into our devices. Providing these integrated platforms to our customers allows for real time feedback to physicians during a procedure.
 
Barbella: What is driving the need to outsource medtech R&D? Does the R&D process even need to be outsourced?
Larson: I think there are two aspects driving the need to outsource. The first is a capacity challenge at OEMs. There are record levels of innovation today to support pipelines, R&D spends are at 11 percent of revenue according to Ernst & Young. With all this innovation, OEMs are experiencing capacity bottle necks in their R&D processes so this if often the first catalyst to start looking for outside assistance.
The second is the level of specialization available from industry partners, such as TE Connectivity. For example, a customer may determine the most expedient route to market for their new innovation is to develop the implant device in-house while partnering with a company like TE to co-create the delivery system. Working together the OEM and CMO can compress time to market.