Disruption and innovation, two sides of the same coin

The pandemic has once again highlighted how important MedTech is to the healthcare infrastructure and ability to adapt to extreme situations. It is time to capitalize on that momentum and seize the chances that lie ahead.

Since the creation of eyeglasses and the stethoscope, medical technology (MedTech) has come a long way. The expansion of a more affluent middle class, as well as an aging global population, are all driving change in the healthcare industry, and the technology that supports it is developing faster than ever before. According to a World Economic Forum report on the healthcare industry, more than a billion individuals would require medical technology reskilling by 2030.

In 2020 and 2021, the Covid-19 pandemic forced healthcare into the future, and, as a result, several promising medical technologies were tested on a massive scale. The impact of the Covid-19 global pandemic will be evaluated, studied, and felt for years to come, especially in the medical device industry. To protect public health, healthcare providers needed to be able to deliver care when they could not safely be near their patients. Technologies to overcome that and other challenges presented by the pandemic have been accelerated, and fast-tracked to market – technologies previously backburnered or stuck in development. The US Food and Drug Administration (FDA), the government body that regulates medical devices, issued regulatory guidance allowing flexibility, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act, otherwise known as 510(k) clearances. With all its challenges, the pandemic has paved the way for many recent advances in medical technology.

In 2022, the question is how those technologies can be used together in a post-pandemic world.

Advances in medical technology – what does the future hold? Innovation has always been a cornerstone of the healthcare and medical device fields, and many specialties are evolving and benefiting from technology and medical advances. But there are a few areas where the most promising recent advances in medical technology are emerging.

Diagnose disease. During the Covid-19 pandemic, diagnosis became a trending topic. Many medical device organizations stepped up to the plate to develop and manufacture tests that would enable the world to flatten the curve and get ahead of the virus. But even before the Covid-19 pandemic accelerated the diagnostic industry, many companies and researchers were working on ways to rapidly – and accurately – diagnose patients. In 2017, for example, the FDA authorized a popular at-home DNA test for use in detecting genetic risk of 10 different diseases.

What’s more, researchers in Korea recently announced the results of a promising study that utilized artificial intelligence (AI) to detect prostate cancer in urine.

Patient monitoring. Thanks to remote patient monitoring (RPM), physicians can now know what is going on with a patient without physically being close. There are several benefits to RPM including better patient outcomes, faster response time, and significant cost reductions over time. In fact, RPM goes hand in hand with telemedicine in reducing the need for patient travel and mitigating everyone’s exposure.

Thanks to legislative changes to medicare for the Covid-19 pandemic, various forms of RPM were approved for reimbursement, effectively increasing the popularity of this new technology.

Prevounce, a provider of medical software, notes that in 2020 an estimated 23.4 million patients utilized some form of remote patient monitoring. The most common types of monitoring were blood pressure, weight, heart rate, and blood sugar, all without having to go into an office or a lab.

This practice is becoming so widespread that a survey conducted by Spyglass Consulting Group found that 88 percent of healthcare providers had invested in or were evaluating adding RPM to their practice.

Artificial intelligence. AI takes on many different forms in healthcare. The primary trend for AI in healthcare 2022 will be in utilizing machine learning to evaluate large amounts of patient data and other information. By creating tailored algorithms, programmers can mimic human thought and write programs that can seemingly think, learn, make decisions, and take action.

No, this does not mean that medical care will suddenly be delivered by sentient robots. However, it does mean that, given a patient’s particular medical record, history, and current symptoms, physicians may be given suggested diagnoses, medications, and treatment plans. The physicians will always have the final say, but the information will be at their disposal.

Overall, by analyzing healthcare data in this robust and comprehensive way, healthcare leaders will be able to use the findings to improve patient outcomes, reduce costs, and boost staff job satisfaction.

Personalized medicine. Many of the latest technological advances in medicine involve AI, which is the technology that mimics human activity, decision-making, and learning. In the healthcare industry, AI-based medical devices have the capability to automate tasks, synthesize data from multiple sources, pinpoint trends, process and analyze information from wearable sensors, identify disease or the onset of medical conditions, predict risks for disease, or complications, and support research. AI could have far-reaching applications in chronic-disease management, medical imaging, and the Internet of Things (IoT).

The potential of recent developments in medical technology is limitless. These developments will allow medical professionals to collect data, diagnose, and treat medical conditions more accurately and less invasively, improving the health and healthcare of people all over the world.

Digital therapeutics. Patients that have chronic illnesses often require ongoing care from their physicians. This care can include patient education, symptom monitoring, medication adjustment, and behavioral changes. Not only is this care costly, but it is also very time-consuming for both medical staff and patients. Now, there are new digital therapeutics that can fill this role.

Digital therapeutics are prescribed by a doctor to a patient for their particular medical condition. These sophisticated software programs can be accessed as apps on a patient’s smartphone or through a personal computer. They go through the same rigorous testing as all medications, including randomized clinical trials. Medical conditions that are well suited for digital therapeutics include diabetes type-I and type-II, cancer, anxiety, musculoskeletal pain, ADHD, asthma, migraines, insomnia, and substance abuse.

As patients use the applications, information about their wellbeing is reported back to their physician. This allows doctors to be able to monitor patients without having to see them regularly, as well as spot problems much earlier than when a patient needs to wait for an appointment.

Advanced telemedicine. Telemedicine took a great leap forward during the Covid-19 pandemic. In January 2020, an estimated 24 percent of healthcare organizations had an existing telehealth program. According to Forrester, an analytics firm, the country was set to complete over a billion virtual care visits by the end of the year. Forced into functionality, many of telehealth’s regulatory barriers have been removed, and healthcare organizations now have nearly a year’s worth of data on how to evaluate and improve telehealth services.

In 2022, many healthcare organizations will be focusing on how best to integrate telehealth services with existing physical ones. Virtual visits will continue to be used as a way to increase access to primary care and urgent care, as well as to improve collaboration with clinics, long-term care facilities, dialysis centers, and mental health services. All of this, however, hinges upon a more permanent lifting of regulatory barriers: The American Medical Association, and others, are urging the Congress to act fast.

Drug development. The development of multiple safe and effective Covid-19 vaccines in less than a year may be remembered as one of the greater scientific accomplishments in human history. The process was sped along not only by regulatory fast-tracking but also by innovations in the ways medical trials are conducted: virtual clinical trials, held mostly online, eased the burden of participation. Combined with a spirit of collaboration rather than competition between pharmaceutical companies, they could pave the way for a bright future in drug development.

Some of the relaxed regulatory procedures around drug development will fade away with the Covid-19 pandemic, but innovative approaches to testing and collaboration could linger. An alliance between several pharmaceutical heavyweights – including Gilead, Novartis, and WuXi AppTec – has already begun collaboratively exploring new antiviral treatments and sharing preliminary data. The FDA has released guidelines for virtual trials, opening up a new frontier for the development and testing of new drugs.

Once Covid-19 is relegated to the history books, what is next?

IoT. The internet of things refers to the invisible network formed by physical objects that are connected to the internet. For healthcare, this encompasses new technologies, such as remote patient monitoring, 5G-enabled devices, and wearable sensors. The more than 500,000 web-enabled medical devices are increasingly interconnected to be able to provide the most accurate and up-to-date patient data.

As technologies and software improve, smart medical devices will be able to network with other nearby smart devices to help improve patient outcomes. This will eventually allow doctors to monitor patients’ status holistically and systematically. For example, one study found that a FitBit is more reliable at measuring physical activity and better at assessing a five-year risk of death than more traditional methods. All patients need to do is make the data they already have accessible.

5G. If the biggest drivers of cutting-edge technology – AI, IoT, and Big Data – are to reach their full potential in healthcare, they need a reliable and lightning-fast internet connection. Enter 5G. With a reliable real-time connection, the most immediate benefits will be seen in telemedicine, expanding access to care for millions. But that is only the beginning. More connected devices, with more authentic data streams, open up the possibility of a revolutionized healthcare system.

With next-to-zero latency, 5G-connected sensors and medical devices can capture and transmit data nearly instantaneously. That will improve patient monitoring, which will in turn improve patient outcomes. Futurists are already considering the benefits of a marriage of 5G, healthcare, and robotics.

But patients will not have to wait long to see a change – experts say 5G-enabled devices will rapidly bring on a new healthcare paradigm, nicknamed 4P, which is predictive, preventative, personalized, and participatory.

Data-driven healthcare. Healthcare’s big data market is expected to reach nearly USD 70 billion by 2025, according to Bain, a consultancy firm. As the collection of health data continues to accelerate, its applications become more widespread, and its potential for improving treatment options and patient outcomes skyrockets. The biggest barrier, however, has been a lack of interoperability – one healthcare organization’s data is not easily transferred to (and easily processed by) another organization. Covid-19 underscored that problem further.

Interoperability took a large step forward in November 2020, when Google Cloud launched its healthcare interoperability readiness program. Aimed at helping payers, providers, and other organizations prepare for the federal government’s interoperability regulations, it gives program participants access to data templates, app blueprints, security tools, and implementation guidelines. If healthcare organizations can get on the same page, the potential of the industry’s big data could quickly turn kinetic.

Mental health technologies. There are several new technologies that have emerged over the past year that can help address a patient’s ongoing mental health needs. While most assessments and initial treatments may still need to be completed by a clinician, there are now additional tools patients can use to improve their mental health between appointments.

The digital therapeutics mentioned above are uniquely suited for providing high-quality ongoing mental healthcare. Increasingly, some apps are able to complete patient intakes and provide an initial diagnosis before a patient ever meets with a provider. A traditional therapy method called cognitive-behavioral therapy (CBT) has been widely adopted and used in digital therapeutics with significant success, when used alongside virtual or in-person therapy, in helping patients change their behavior.

Another technology newly being utilized for mental health is the use of video games. Just recently, the FDA authorized EndeavorRX, the first only prescription video game designed to treat ADHD in children aged eight to 12. In clinical studies, 73 percent of participants reported an increased ability to pay attention after just one month of treatment with zero adverse side effects.

Nanotechnology. Nanomedicine is the medical application of nanotechnology, the technology that operates on the atomic, molecular, or supramolecular scale. For something of such a small size, the potential is huge – nanomedicine has applications in imaging, sensing, diagnosis, and delivery through medical devices.

Researchers are finding new ways to use nanomedicine to target individual cells, and in 2022, that research will be put into action. CytImmune Sciences, a leader in cancer nanomedicine, has recently completed a Phase-I trial of using gold nanoparticles to target drug delivery to tumors; BlueWillow Biologics, a biopharmaceutical company, has developed nanotech that fights viruses and bacteria.

Smart pacemakers. The artificial pacemaker, which dates back over 100 years, is still a critical piece of medical technology – over a million patients use them. By delivering electrical impulses to heart muscle chambers, they can prevent or correct life-threatening heart arrhythmias. Remotely monitoring these devices is an essential part of their functionality. Traditionally, that monitoring has been far from optimal, relying on complex interfaces that the patient may not fully understand.

In 2022, pacemakers will get a little bit smarter. By enabling pacemakers with Bluetooth technology, they can be linked with smartphone-based mobile apps that patients better understand and utilize. That, in turn, will improve remote monitoring, and, as a result, patient outcomes.

Lab-on-a-chip. If it is taking too long to get samples to the lab, why not bring the lab to the samples? That was the idea of researchers at Stanford University, who recently developed what they call a lab-on-a-chip based on CRISPR enzyme Cas12. About half the size of a credit card, it contains a complex network of channels smaller than the width of a human hair and can deliver a coronavirus test’s results in under 30 minutes.

Researchers say that the test could be modified to detect other infections, too, by recalibrating the CRISPR enzyme for a different genetic marker. As the Covid-19 pandemic taught the world, testing is the first step in combating infectious disease. With a lab-on-a-chip, that testing can be done quickly, safely, cheaply, and more efficiently.

What role will MedTech companies play in the future of health? Conventional MedTechs traditionally have focused their business operations and investments on manufacturing and selling technologically advanced medical products, such as diagnostic equipment, implantable devices, monitoring devices, or other medical supplies. However, as evolving consumer health needs and increasing data availability drive development of new solutions that go beyond the device, the implications for these companies’ future market viability could be considerable. For example, innovative medical solutions will be enhanced by nontraditional consumer technology and digital health disruptors, creating data-centric offerings and clinically differentiated devices. Flexible consumption models are emerging in which companies offer services on a per-patient, per-use basis, providing alternatives to traditional capital-intensive models. Health will be monitored on a continuum of care, with providers focusing on devices and equipment that help improve patient outcomes. Decreasing reliance on traditional product-centric solutions will be offset by increasing need for consumer preventive wellness solutions and post-procedure monitoring capabilities.

Many MedTech companies are already beginning to incorporate always-on biosensors and software into devices that can generate, gather, and share data. That is an important step forward, but to create sustainable clinical and business value, MedTechs will need to evolve from their current product-supplier role and define where they want to play, and how they want to win in the future of health via these new roles.

Six future positions in particular can be imagined, each of which will enable MedTech businesses to give real and differentiated value and prosper in tomorrow’s consumer-centric, digitally powered healthcare marketplace.

Next-gen commodities supplier. Similar to the product-supplier role, most current MedTechs hold, the next-gen commodities supplier provides clinically sound products at a much lower price via superior efficiencies that lead to meaningful and sustainable cost advantages. The role takes advantage of digitally enabled supply chain capabilities, access to low cost supplies and labor, partnerships that leverage new data, and a global network to achieve an industry-leading cost-of-goods-sold profile. The next-gen commodities supplier role is critical to the health ecosystem because it provides good enough products at the lowest prices, similar to generics manufacturers in the pharmaceutical industry. Potential variations of this role include full-spectrum manufacturer with lean R&D and commercial functions; commodity manufacturing company providing medical devices; and vertically integrated manufacturer-distributor.

Best-in-class innovator. A best-in-class innovator provides products with substantial clinical and economic differentiation, such as devices that can cure specific diseases, significantly slow down disease progression, or enable personalized treatment with higher clinical utilization. Best-in-class innovators excel in the idea-to market process and deliver superior product innovations via customer-centric, data-driven, open-innovation capabilities with significant access to world-class medical researchers and clinicians. Success in this role requires an agile ability to evaluate innovative ideas, both internally and with external partners. Market development will be another required capability, as many of the products this role introduces will be first-of-their-kind. Investments in comparative effectiveness studies may be needed to support market-shaping and/or penetration efforts. Although this role is still a product supplier, it adds value to the health ecosystem by regularly and consistently designing, developing, and introducing truly value-enhancing, differentiated products. Potential variations of this role include full-spectrum manufacturer with minimum commercial capabilities (process or product technology innovators); R&D and small- or medium-scale manufacturing capabilities only (product technology innovators only); and academic or research institutions.

Medical solutions-as-a-service provider. A medical-solutions-as-a-service company elevates the transaction-based product supplier role to that of a customer business partner via data-driven delivery of holistic solutions, including hardware, software, and professional services (e.g., clinical workflow consulting, analytics, and management, enabling customers to optimize clinical, operational, and economic outcomes on a per-patient basis. Companies that adopt this role will need to embrace outcome-based and/or subscription-based revenue models, as traditional volume-based models are unlikely to be as effective. These MedTechs will be truly integrated into their customers’ operations and eventually assume full responsibility for specific enabling functions and processes (e.g., device data management and analytics). Potential variations of this role include comprehensive solutions provider, including all hardware, software, and service needs; provider operations integrator creating meaningful value clinically and operationally; and medical solutions aggregator from different sources, providing a single-solution platform. The high-tech industry went through a similar evolution from selling products to delivering solutions a decade ago. Key learnings from that process may be helpful to MedTech companies planning to become a service provider.

Disease owner. A MedTech company that owns a disease provides superior care coordination and a one-stop shop portfolio of devices, digital tools, services, and, potentially, drugs to treat or manage a specific disease across the patient journey, from diagnosis and treatment to ongoing monitoring. We expect to see this role be effective in managing chronic diseases (e.g., diabetes, renal, cardiovascular, and respiratory care) by offering solutions that go across the care continuum and therapy lines, from patient diagnosis through monitoring. The disease owner role aligns with population health goals rather than specific procedures or episodes, and it will be critical in the care model transition from fee-for-service to fee-for-value. A capitated payment model could be structured so that payers, providers, and manufacturers have aligned incentives to optimize patient care with minimized costs. Potential variations of this role include full-spectrum manufacturer for specific disease states and vertically integrated manufacturer-provider.

Ecosystem data and informatics providers. Many hospitals and health systems make minimal use of analytics due to data availability and interoperability challenges. Data is the new gold in the increasingly digitized healthcare space, given its vital role in improving clinical decision-making and care quality. We expect an ecosystem data and informatics provider role will emerge to collect, aggregate, curate, analyze, and interpret data from various sources – and enable data interoperability – to generate superior insights and recommend actionable next steps so that providers can deliver superior care. Potential variations of this role include data conveners and AI algorithm developers for improved products and treatments; application developers and insight generators; and advisory services for hospital systems. Because big health IT companies may already have a competitive edge to win in this role, and consumer tech giants are also investing heavily in healthcare, MedTech companies interested in this role will need to dramatically transform their capabilities or leverage these same consumer tech leaders via partnerships.

Consumer health enablers. Healthcare is transitioning to a prevention and wellness-oriented model, with more care delivery happening in consumers’ homes instead of the traditional physician’s office or hospital. The consumer health enabler role empowers consumers to proactively and continuously manage their own health by collecting and analyzing data from various diagnostic devices (e.g., implantable, wearable, and environmental sensors) to generate superior, consumer-friendly insights and care recommendations delivered via telehealth and virtual physician tools. This role supports early disease detection and behavioral nudging by integrating consumer health data with core determinants of health, such as an annual physical (including blood pressure, pulse rate, RBC and WBC count, and psychological testing) and social determinants of health data. Variations of this role include consumer-friendly, non-medical-grade device manufacturers, and applications and platforms for virtual preventive and wellness services and care management. To succeed as a consumer health enabler, MedTech companies will need to shift from a provider-centric to a consumer-centric business model with efficient and effective capabilities to reach and engage a broad consumer-customer base.

As they evolve to these roles, MedTechs will need to:

Strengthen core capabilities to specialize either as a low-cost, highly efficient supplier or a premium supplier of innovative and differentiated products;

Expand offerings to create holistic solutions by either combining products, software, and services to help providers achieve clinical and operational excellence or integrating all products and services required to treat a selected disease via partnerships or acquisitions; and
Enter new spaces by providing transformative offerings that either facilitate data transfer, insight generation, and decision optimization across the health ecosystem, or enable consumers to better and more proactively manage their health.

The time to act is now. The MedTech company of the future will likely operate in a dramatically altered healthcare landscape. Revenue pool for the traditional MedTech role is expected to continue shrinking as the value it delivers decreases over time, and new roles evolve. As company leaders plan their migration strategy, some may decide to focus on excelling in a single role, while others may choose to leverage investments in new technologies to take on several. In either case, they should quickly assess their current offerings, customers, and unique capabilities (and identify gaps and ways to fill them) or risk being outmaneuvered by competitors.

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