Medical Design Briefs is reporting from MD&M West 2019. Send us your questions and comments below.
ANAHEIM, CA — The factors influencing the medtech industry's ability to innovate in 2019 range from cybersecurity to disruptive technology from companies like Amazon. But manufacturers will also need to address the effects of tax reform and an ever-evolving trade policy. Four experts weighed in with what to watch for and advice on how to navigate through it all.
- Mike Devereux, Partner and Director of Manufacturing, Distribution, and Plastics Industry Services, Mueller Prost
- Bryan O'Byrne, Chief of International Affairs and Trade Policy, U.S. Small Business Administration
- Yarmela Pavlovic, Partner, Hogan Lovells
- Vicki Barbur, Senior Director, IP and Technology Commercialization, Commercial Business, Battelle
When asked to name the one issue that will keep medical device executives and manufacturers up at night, the panel weighed in with some big ones:
Devereux says that the medtech CFO or tax director will have the new tax law to sort through and understand: “The new tax law has so much information. The 1097-page tax bill has a lot of information they’ve issued all sorts of guidance — some of which just came out in the last couple of weeks.
“Cybersecurity is a really critical issue for the medtech industry,” says Pavlovic. “Companies are at various stages of adoption of cybersecurity policies. Very young companies coming from the tech industry, cybersecurity is a much more natural fit for them. But there are a lot of companies that are grappling with legacy products and they are trying to implement cybersecurity controls based on more modern technologies for products where those concerns were not part of the original design and development. There is a huge range of stages that companies are at.” The second issue, she says, is continued reimbursement challenges. “For some technologies, it’s very straightforward, and for others, there are rapidly evolving reimbursement models that make it challenging for companies.
O'Byrne’s says that from his perspective, a constantly changing trade policy environment is difficult for medtech firms. “From the time I get on the train in the morning by the time I get to the office, the policy has changed,” he says. “We have an administration that is quite activist in trade policy. There is also a rethinking of trade policy. As a result, there is also a lot of friction. However, there is also quite a bit of good news, especially for the medical device sector.”
From a scientific point of view, Barbur says that one of the challenges for medtech is the disruption in this particular market. “Companies like Amazon, which can do anything anywhere in an instant of time,” she says are making waves in the healthcare industry. “As a CTO or president,” she says, “it’s the fast pace at which technology is changing and how we stay abreast of the changes to be on the leading edge. It interesting how we’re putting all of these devices together, miniaturizing them, looking at the cloud for capturing that type of information. Do we have the time and the diligence to do the research to make sure that these products are safe? And that’s what we are all concerned about. Any company is concerned about liability and also about having these products approved by FDA. They need the rigor, the scientific discovery, and resilience and repeatability.”
Emerging technologies like AI-enabled devices and robotics will also influence medical innovation in 2019. Pavlovic notes that these technologies are already having an enormous impact. “For the last 10 years, we’ve been talking about big data but not necessarily knowing how we would use it. We finally now seeing actual medical solutions come out of the big data repositories that have been collected,” she says. “So, whether that’s image analysis tools that can speed up workflows for radiologists or whether its data analysis tools that are analyzing electronic health record data to try to predict which patients might develop sepsis.”
Even on the product discovery side such as precision medicine, for example, she says some of that this is already coming to fruition. “Of all of the product spaces that I work in, AI-based precision medicine is the most rapidly evolving. There are an enormous number of new market entrants. In many ways, this is a continuum.”
She says that digital health tools that will collect data that can then be used in some of those AI-based algorithms. “With robotics,” she says, “it comes full circle — whether you’re talking about robotic surgical that can reduce the time and effort that physicians need to put into their work, allowing them to see more patients or reducing the burden of a disease on a patient. We see real changes and real opportunities in the future to make use of these technologies. It’s no longer just tech trying to bring their expertise into healthcare. There are traditional healthcare companies trying to develop their own expertise.”
Barbur add that as much as the technology can help us to deliver data-driven capabilities with the information and conservative approaches, it’s really how the FDA approve these devices going forward. “I saw a graphic that outlines smart surgery where in some respects the kinds of things that we’re talking about being able to make decisions on the fly is going to enable faster turnaround of patients in the ORs” she says. “It’s based on the intelligence that these models bring to data and the decision making. So that’s the caution that will be critical.
The other technology making headway is voice-enabled technology. “There’s no doubt that the Alexas, the Google Home, they are actually being used tremendously to help with the personalization and digitization of healthcare. Voice-enabled devices, whether they’re in the home or OR, that will be the technology of the future.”
Pavlovic says that a significant focus in 2019 for medtech should actually be on the physician voice. “The physician voice is incredibly important. We’ve been talking about the great new world of data collection and analysis producing novel insights and workflow tools but keeping in mind the physician who must deal with all of these data points will be meaningful for the patient and their care,” she says. “To the extent that we can ease that burden while offering real solutions to help their patients will have a meaningful path forward. Without that we will have increased resistance from the medical community in terms of adoption.
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