Subject to stringent regulatory regimes with considerable legacy complications hindering new infrastructure, technology, or processes — most hospitals are also saddled with significant bureaucracy, and a general fear of change. These facts contribute to a reality in which healthcare organizations are expected to be downright laggardly where it comes to modern business practices and supporting technologies.
Of course, much of that started to change in 2010 with the arrival of the Affordable Care Act. The push for modernized patient data management, combined with higher standards for care and the need to moderate billing (and in turn costs) set in motion wholesale changes to how healthcare people, processes and systems worked. Just as the sector is settling down again, another round of structural changes seem set to throw more dust back in the air.
Flux as the New Stasis
In January of 2018, the triumvirate of Amazon, JP Morgan, and Berkshire Hathaway formed a joint venture with the stated goal of disrupting the healthcare space. While health insurance has been targeted as the primary focus (at least initially) and the market limited (again, at first) to the 1,000,000 or so employees already covered through the constituent companies’ insurance plans, the joint venture has made it clear that its ultimate ambitions are far broader.
At the same time, Amazon as a solo act has been inching forward with its long-rumored entrance into other healthcare verticals. Among other moves, the eCommerce behemoth has made waves for its recent purchase of PillPack and recruitment of high-profile staff. While it remains to be seen exactly what shape Amazon’s healthcare business model will take, it is becoming increasingly clear that the company intends to be a big player in the sector.
If that weren’t enough ongoing and impending industry upheaval, there’s also the matter of CVS’s recently concluded $69 billion mega purchase of managed healthcare company Aetna. This move not only reflects trends toward market consolidation and vertical integration, but is a bold gambit by CVS, a pharmacy benefit management company, to move away from its role as a healthcare intermediary and remake itself as something more closely resembling a full-service preventative healthcare clinic.
As CVS CEO Larry Merlo explained regarding the long-term strategy behind the merger, “When you walk into CVS, there’s the pharmacy. What if there’s a vision and audiology center, and perhaps a nutritionist, and some sort of care manager?”
Make no mistake, this is yet another play (backed by unimaginably strength of capital and resources) to totally transform the industry as a whole. Leveraging data insights integrated across the healthcare supply chain, an unparalleled distribution network, and principles of customer centricity along with value-based care, CVS intends to redefine medicine.
While the consequences of these tectonic movements won’t be fully understood for years, what is clear is that 2019 has more and bigger disruptions in store for hospitals and medical centers. It likely won’t be enough to simply brace for impact and wait out the storm. To avoid being crushed beneath it, you’ll want to be on top of the tsunami of transformation to ride it out. To that point, healthcare administrators will need to stay ahead of the trends and focus on activities they know will improve cost-effective patient care.
Without further ado then, here are 5 MedTech trends to for you to pay extra attention when considering strategic planning:
Wearables Prove their Mettle Predicting & Preventing Health Issues
Wearables are well-established in the fitness market, but their use as real medical tools has been limited. However, that’s set to change as improvements in technology mean they’re now smaller, lighter and more reliable than earlier generations. They’re unobtrusive, interface easily with smartphones and, with high powered sensors, are capable of collecting detailed information over a long period.
Wearables are especially useful for helping to treating chronic disease such as asthma, atrial fibrillation or diabetes, and products are now available that give early detection of cancer or degenerative disorders like Parkinson's.
It is hoped that a move to fund wearables using a merit-based incentive payments structure will help increase their adoption, as will the huge number of mHealth apps (about 325,000 in 2017). The FDA is sufficiently impressed by the breadth of opportunities that they’ve launched a pre-certification program for product providers to speed up regulatory approval and time to market.
According to a recent report, most healthcare providers say wearables are an important part of their planned IoT investments.
Consider just a few of the innovative wearables coming out:
- Kardia Mobile monitors heart rhythm to detect signs of arterial fibrillation as a precursor to stroke.
- TempTraq monitors the temperature of babies to give parents an earlier and more accurate view of homeostatic deviations from baseline.
- Kenzen Patch analyzes the electrolytes and proteins in sweat to help determine if glucose levels are too high or if the wearer is dehydrated.
- myCareCentricEpilesy, a solution currently under evaluation by the NHS, collects data such as sleep patterns, exercise and temperature to improve early detection and management of Epilepsy.
- Path Finder is a shoe-mounted device that projects a laser line in front of the wearer to “hack” the brains of Parkinson's Patients to bypass neurological impairments and prevent "gait freeze”.
Strategic planning considerations: with so much data available, decisions need to be made on what to collect and how to use it. The decision will be informed, in part, by what is needed to meet the billing requirements for merit-based payments, and how the data can complement other clinical applications. ROI will need to be considered as well. Just because you can find a new and cool way to do something does not necessarily make it better or more cost-effective than the old way of doing it. For wearables owned and issued by the healthcare provider, an effective approach to inventory management will also need to be worked out.
Radiology is the New Frontier for AI
AI — whether it's machine learning, NLP, robotic process automation, or related techniques — is no stranger to healthcare. Among other uses, this technology is helping healthcare providers make sense of the huge volumes of data they now routinely gather while delivering patient care. It’s used to manage electronic health records, deliver routine tasks – such as lab test analysis – and can even act as a virtual nurse. But it’s in radiology that the most profound and most immediately available advantages will be felt in 2019.
Investments in AI for medical imaging are forecast to reach $2 billion by 2023, spurred on by the need to reduce costs associated with the increased number of imaging procedures used to improve early stage disease detection, and the desire to make greater use of imaging data already collected. According to GE Healthcare, 90% of healthcare data comes from imaging technology, and a whopping 97% isn’t even used.
Over the last 10 years or so, radiology AI has been hamstrung by clinical concerns around accuracy and usability, but now that's changing. The American College of Radiology's Data Science Institute has established a program to examine the opportunities for AI in a range of radiological applications and vendors are investing in new products.
GE Healthcare's Edison platform, for example integrates data from applications and devices to improve clinical insight, while AI-pathway, developed by Siemens, helps physicians make improved diagnostic and therapeutic decisions. Another player in the space, Aidoc, uses AI to rapidly analyze CT scans — automatically prioritizing and accelerating critical medical interventions.
Healthcare providers are already benefiting. A system developed by researchers at John Radcliffe Hospital that extracts over 80,000 data points from a single echocardiogram image to increase diagnostic accuracy is forecast to deliver annual cost savings of £300m to the NHS.
Strategic planning considerations: many of the most innovative products are still in development, so product evaluation should focus on delivery timelines and referrals from any early users. This will help identify practical options, challenges and costs that can be used, along with input from physicians, to build a business case for the adoption of new equipment.
Remote Patient Monitoring Enhances Proactive & Cost-Effective Care
Remote Patient Monitoring (or RPM) collects biometric data and other patient health statistics beyond normal clinical settings, and alerts clinicians when help is needed. RPM systems are becoming more attractive because they can often circumvent the costs of patient readmission and avoid the inefficiency costs of patients struggling to keep appointments.
Products are also becoming more sophisticated and able to deal with a much wider range of conditions that are expensive to treat — such as heart failure. For context, the US currently spends about $30 billion on treatment but that’s projected to rise to $70 billion in the next 10 years.
The University of Pittsburgh Medical Center and Mount Sinai Hospital are already using remote patient monitoring to improve the outpatient care journey and, again, vendors are investing to capitalize on the opportunities.
Taking RPM a step further, Abbot’s Confirm Rx is the world's first insertable cardiac monitor that allows patients to connect their implant to a mobile app. The device, implanted under the skin using a simple outpatient procedure, continuously monitors heart rhythms with no additional hardware such as a bedside transmitter.
On the other end of the care equation, clinical technicians, faced with a growing number of remote patients, are helped by products like the LATITUDE NXT that automatically interrogate the devices, aggregate, and manage the data collected.
Telemedicine is another big part of remote patient monitoring. With improvements in data compression, live stream fidelity, high resolution video imaging, and secure transmission environments, telemedicine has exploded in the last few years. The idea of a doctor being a click away has lowered tremendously the barriers to consultation – leading to more people receiving medical intervention earlier, when treatment is cheaper and more effective.
Telemedicine, as one form of remote monitoring, also allows hospitals to staff more leanly (over night and on holidays, for instance), better manage high capacity scenarios, and bridge regional skills gaps by relying on a cadre of appropriately certified doctors located anyone on the planet. These trends will only accelerate and enjoy greater adoption going into 2019.
Strategic planning considerations: enlist the support of a senior radiologist to evaluate options on a department-by-department or procedure-by-procedure basis, with an emphasis on identifying applications with the greatest ROI. RPM won’t benefit everyone, so an assessment of patient suitability should be conducted in parallel.
Connected Medical Devices Put Cybersecurity Atop HIT Agendas
The aforementioned MedTech trends have one thing in common: they increase the amount of sensitive data collected, stored, and transmitted across the hospital network. Breaching the network lets criminals harvest sensitive data and embed themselves within your information technology ecosystem. That type of intrusion can lead to financial crimes, acts of terrorism, the targeting of specific individuals, ransom extortions, or identity theft.
Healthcare provider networks are often easy pickings for bad actors. Medical networks contain thousands of endpoints spread out over vast distances and including abundant legacy technology components that lack adequate defenses for modern threats. What’s more, those networks relay proprietary communication protocols that most IT tools and many HIT teams don’t properly understand; without context-aware insight into traffic flow, you’ll be hard pressed to impose any sort of meaningful security oversight.
The result? Data breaches cost the U.S. healthcare industry $6 billion a year, with breaches like those to Hancock Regional Hospital, The Boston Children’s Hospital, and Hurley Medical Center illustrating the operational and reputational damages hospitals suffer after a successful attack.
Strategic planning considerations: a hospital network has so many access points, a well-thought-out and layered defense architecture that reduces the attack surface is essential. Consider best-in-class tools that continually evaluate the number, type and location of connected devices; perform automated risk assessment and compliance checks; and use AI-based containment and response techniques.
Regulations Are Getting Tougher — on All Fronts
There’s no shortage of regulations in the healthcare sector and violating them is an expensive business. HIPAA transgressions could result in fines ranging from $100 to $50,000, as several organizations in the sector have learned first-hand. For its part, non-compliance with the recently introduced EU General Data Protection Regulation compels maximum fines of €20million.
It’s inevitable that general healthcare and specific data protection regulations will widen and deepen, but it is changes to medical device regulations that will dominate the sector over the next year or so.
The FDA recently announced its intention to overhaul the medical device approval process; while the ripple effect that these changes will have on the broader MedTech ecosystem remains to be seen, it is clear already that there will be ripples aplenty. Prior to that announcement from the FDA, came the release of their Medical Device Safety Action Plan, which lacking the force of law, prompted Congress to discuss the need for legislation around medical device and information technology management in healthcare.
The Internet of Medical Things Resilience Partnership Act aims to develop a cybersecurity framework for adoption by medical device manufacturers and users to improve resilience to breaches, and the Medical Device Cybersecurity Act will 1) require manufacturers to improve remote access protection, 2) ensure updates and patches are timely and free, and 3) create an annual cyber report card that documents device security health.
Europe usually leading the way in regulations, is still playing catch up when it comes to medical devices, having formulated new regulations set to take effect in 2020 and 2022.
Strategic planning considerations: while most of the medical device regulatory burden falls on device manufacturers, healthcare providers should still keep a watchful eye out for early warning of any policy or procedural changes required on their end. Connected-infrastructure-aware and regulation-informed inventory management solutions will be a huge help when it comes demonstrating compliance — allowing the organization to easily check the compliance status of all medical devices and automatically provide an audit trail.
While it’s impossible to foresee the exact contours of the future healthcare industry, it’s certainly instructive to study emerging trends and disruptive trajectories.
Smart MedTech adoption and thoughtful administrative tooling can help enhance disruption resiliency, while improving patient care and reducing operational costs. Though MedTech is already ubiquitous across contemporary healthcare practices, there remains a great deal of room for modernization and expansion into new applications. Advances in remote patient monitoring, imaging AI and wearables will irrevocably change how healthcare is practiced in 2019.
At the same time, those changes will bring increased cybersecurity risk along with added regulatory oversight and scrutiny. Still, with careful planning, foresight, and purpose-specific technological solutions in place, those risks can not only be managed but innovation can be leveraged as a profound opportunity and key differentiator in the face of uncertain market conditions.