Flex is an engineering and consulting company that works in a variety of industries. One is healthcare and it’s been helping companies develop new products and services that improve medical care. We checked out some of the biomedical technologies that Flex has worked on recently while at CES 2018 in Las Vegas, and got a chance to ask Kal Patel, M.D., SVP of Digital Health at Flex, about the company’s approach to developing new biomedical technologies, what new services it’s offering, and what the future holds for medicine.
Flex has significant expertise in health, and its knowhow in the field spans a gamut of solutions from medical devices to drugs delivery. Some of the examples of the company’s efforts that were presented at CES 2018 are Novocure’s electric field skull cap for patients with glioblastoma, Naked Labs’ fitness tracker and home body scanner, and Flex’s expertise in digital health.
Medgadget: How long has Flex been involved with healthcare?
Dr. Kal Patel: Flex has more than 20 years of healthcare industry expertise and has deployed more than 75 regulated hardware and software medical products. Eighty-five percent of the top medical device manufacturers work with Flex and we are the number one provider of medical device supply chain solutions.
Flex does more than a billion dollars in revenue each in 12 different industries, including healthcare, automotive, telecom, consumer tech, connected living and others. We have a depth of cross-industry expertise that can help customers anticipate technology trends and make their products smarter and more connected.
Medgadget: What is your approach toward biomedical projects? (i.e. do you have a cadre of biomed engineers, specialized team working on medtech, etc?)
Dr. Patel: We have 450 medical design engineers and six medical design centers from Hollis, New Hampshire to Haifa, Israel. Around the world, 25 Flex medical facilities manufacture products for our customers, some of which we designed, or co-designed. We create best-in-class reference designs for new medical products and technologies, and then work with our customers to turn these designs into mass-production products. This allows us to use our experience in wireless technologies, plastics encapsulation and other capabilities to make medical devices smarter and more connected, and soon, provide more useful IoT information for pharma companies.
Medgadget: Where do you see the future of health and where does Flex fit in to deliver on that future?
Dr. Patel: The future of healthcare is inextricably tied to the Internet of Things (IoT) and connected devices. As it stands, the global IoT healthcare market is expected to top $160 billion by 2020, and there are tremendous opportunities to make healthcare more efficient and intelligent.
If you look specifically at digital health, Flex is focused on helping companies connect regulated medical devices and therapies and turn the data from those devices into actionable insights that can have a measurable impact. When deployed correctly and securely, connected devices have enormous potential to open up a new stream of clinical data that can help consumers better manage their health, providers to deliver more personalized, proactive care, and pharma and medtech companies to optimize their devices and drugs.
When you look at the healthcare marketplace today, you see a lot of siloed solutions that operate on their own, and that don’t integrate smoothly with how we live and work, and how medical professionals live and work. This cuts across both hardware and software – from the electronic medical record systems that don’t communicate between healthcare providers to medical treatments that each require a stand-alone app. There are a lot of challenges to fixing the connectivity and interoperability issue for the healthcare ecosystem given all the changes in the industry, but Flex is helping the pharma and medtech players navigate these critical issues with what we hope is a solution that brings medical device and therapy data together, then applies machine learning and advanced algorithms to transform it into actionable insights.
Medgadget: Can you give us details on some of the most interesting or challenging projects that you already delivered on for pharmaceutical companies or medical technology manufacturers?
Dr. Patel: One example would be the Enable Injections Patch Pump. It’s a wearable, disposable patch pump that can deliver small or large volume doses of drugs, especially biologics that are more viscous and therefore difficult to deliver. The Patch Pump supports patient self-administration of drugs that they would otherwise have to have an IV in the hospital to receive. The Flex team worked on design for manufacturing and connectivity, and we also do all the plastics molding for them and manufacturing.
Medgadget: What are the unique challenges in healthcare and please comment on the regulations that you have to overcome?
Dr. Patel: Despite the promise that digital health holds for pharma and medtech companies, there are two main barriers that we see holding the industry back from investing in the development of digital health solutions– regulatory hurdles and the perceived return on investment (ROI) for medical companies. There’s also another threat of digital disruption when the major healthcare payers in the US, i.e. employers and their employees, look at the ROI of their health care costs.
Given the persistently unclear and complex regulatory environment pharmaceutical companies face when considering a move into digital, along with the significant regulatory investment such a move requires, their reluctance is understandable.
The FDA’s actions in recent years suggest regulations for software products will evolve at an increasing pace, adding complexity to pharma and medtech companies’ already demanding regulatory responsibilities. In the past two years the FDA has issued eight significant guidance documents related to software, some of which overlap or conflict. And that’s just in the U.S. Imagine the complexity as pharma or medtech companies attempt to launch drugs or therapies in new markets outside of the U.S.
In addition to the complexity of the FDA regulations, there’s also the complexity of reconciling dramatically different regulatory cycles for drugs, medical devices and software. This complexity requires specialized regulatory expertise that pharma companies don’t want to invest in building. There is a desire by pharma and medtech companies to focus solely on the regulatory submission for their drug and offload the submission of the software components to other partners.
The perceived ROI of digital health solutions is also a challenge. Pharma companies are balancing their digital investments against opportunities for TV ads or additional sales staff. But there are many possible short-term rewards for pharma companies. These rewards range from improved patient adherence to better patient outcomes, and include opportunities for new business models enabled by a more connected world. The ROI of digital can also take time. Patients need their health apps to work well, but software development is an iterative process of ongoing improvements, which is different from the traditional pharma model of major up-front investment, which generally scales back once a drug has FDA approval.
We believe that a digital innovation model can lead to greater improvements with less risk, with a higher likelihood of success than the traditional drug innovation model, which studies show to be broken, with diminishing returns.
At the same time, Amazon just announced that they are partnering with JP Morgan and Berkshire Hathaway to disrupt the U.S. healthcare system – starting with their own employees. This should be a wakeup call for medtech and pharma companies to realize that their biggest future competitors may not be traditional healthcare providers. Companies like Amazon have the technology resources and culture of innovation to build compelling connected consumer hardware and services, and the scale to reinvent how healthcare is delivered. Imagine medication reminders being delivered by your voice assistant, as opposed to yet another siloed app that lacks context about our daily lives. Then that same platform could order a prescription refill to be fulfilled directly by the pharmacy (or Amazon). But even at the scale these companies can reach, there’s still a need for a unified FDA-regulated platform to help combine data from multiple devices or drugs.
Medgadget: Flex has developed BrightInsight, a solution that the company describes as “an intelligent platform that integrates drug and device data for real-time insights.” Can you elaborate how it works?
Dr. Patel: BrightInsight is a managed services platform with an open, secure and regulated architecture that enables data to be captured, integrated and analyzed from multiple apps, devices or drugs. This will allow Flex to deliver insights to pharmaceutical or medical device companies that they’ve never had before, much more rapidly. All of the data will be linked to one system, allowing companies to add multiple solutions onto the platform for a truly holistic view across their products and patient populations.
With access to real-time data and actionable insights built on a regulated platform, healthcare stakeholders can introduce more robust feature sets with their digital health solutions, such as controlling connected devices, drug dosing, decision support, personalized patient interventions, trend analysis and AI-driven insights.
Introducing more advanced capabilities like these can create operational efficiencies through automation and scale, improve patient outcomes through interventions and engagement, and ultimately optimize the value of connected drug, device or combination products.