Assuming the COVID-19 pandemic recedes in severity if not cases, 2022 brings the potential to re-focus on the trends that benefit MedTech globally – an aging population that requires more healthcare and the increasing access to healthcare in emerging markets. However, global cost pressures will remain as fee-for-service payment models continue to decline, replaced by payment for outcomes and risk sharing. In addition, price pressures, like those created by China’s new national centralized tender program, will squeeze profits. Here are a few additional MedTech trends worth watching in 2022.

1. The European regulatory landscape will continue to be problematic in 2022, the first full calendar year of the EU MDR and featuring the introduction of the EU IVDR. Although IVDR certification timelines have recently been extended beyond the formal date of application in May 2022, problems remain. Prior to IVDR and its new concept of classifications, only ~20% of IVDs had to undergo an assessment of conformity by a notified body. Now as many as ~80% will need a notified body assessment. However, for a variety of reasons, there continues to be a shortage of notified bodies. Even if the notified body shortage begins to recede in the back half of 2022, clinical (performance evaluation) requirements and post-market requirements will present significant challenges for both MedTech and IVD manufacturers. Looking ahead to 2023, as manufacturers overcome these EU regulatory hurdles, they will need to prepare for the UK Conformity Standard which will be required starting in June 2023 for all devices entering the UK market.
2. Fundamental shifts in medical device sales and servicing, created by the combination of our increasingly digital world and the impact of the pandemic, are here to stay. Marketing, sales, training, and servicing are moving rapidly towards virtual channels, resulting in greater utility and convenience for clinicians and their institutions, and better efficiency for manufacturers.  No doubt certain “free” services that hospitals and clinicians have come to depend on will likely remain (e.g, assistance with complex procedures and training on device use). Numerous studies indicate that both clinicians and sales reps prefer virtual engagement, and this transition should lead to seamless customer data, which should in turn drive stronger relationships and higher satisfaction. However, virtual engagement will put pressure on MedTech manufacturers, who have traditionally not been at the forefront of digital innovation, to build customer-centric digital systems that address a broad range of customer needs across sales, training, servicing, inventory management, and beyond. 
3. Even as the pandemic resolves, the market will continue to emphasize point-of-care testing as close to the patient as possible. This will include not just innovation around IVD diagnostics but also around traditional diagnostic tools. Point-of-care diagnostics will continue to innovate and expand, in part because the pandemic put massive pressure on IVD companies to develop rapid/point-of-care testing. Additionally, the full potential of telehealth is restricted by the limitations of virtual diagnostic capabilities. Consider visual assessments of eyes, ears, and throats, listening for fluid in the lungs, assessing temperature, skin pallor, or diaphoresis, closely examining a rash – these are a few examples of diagnostics that remain limited in a virtual environment. 2022 will see further development and expansion of clinically reliable, home-based tools that may ultimately become as ubiquitous as the thermometer.
4. Despite increasing acceptance of digital therapeutic (DTx) and digital care tools, they will continue to struggle for reimbursement in 2022. The overall body of clinical evidence on app effectiveness has grown with almost 1,500 studies published in the past five years. Further, at least 25 DTx products have been granted market authorization through regulatory processes, and another 23 are commercially available. Yet only a select few have secured coverage and they tend to include an associated device component, like Propellor Health for asthma and COPD, and Livongo for diabetes. A few others, mostly addressing higher cost disease categories like diabetes, obesity, and COPD, have secured employer benefit inclusion or qualify for FSA expense. But payer reluctance is likely to continue in part because digitals tools are novel and provide care in ways that do not necessarily mesh with existing reimbursement structures. In addition, it is inherently challenging to prove a cost benefit to a payer if your product is additive (e.g., does not replace an existing product/service). Finally, digital tools have not yet proven themselves, as a concept, to consistently deliver on cost and/or outcomes. All this combines to create obstacles for coverage and necessitates long pathways to pursue coverage and generate strong supporting evidence. 
5. 2022 could bring the first serious competition to the twenty-year dominance of Intuitive’s surgical robot, da Vinci. In the last ten years, successful commercialization of surgical robots has been limited to areas where da Vinci is not dominant (e.g., orthopedics). However, in 2022, several surgical robots will compete in da Vinci’s core markets and are claiming advantages in cost, size, and haptic feedback. These products are taking approvals and experience from non-U.S. markets and are now aiming at the U.S. The most notable might be Medtronic’s long awaited soft tissue robot HUGO, which garnered FDA investigational device exemption in late 2021 to add to its CE mark and Health Canada license. CMR Surgical’s Versius raised another $600M in 2021 and in November Brazil became the 11th country to introduce it. In the U.S., the Versius system is currently under FDA review, but the company already has commercial teams ready to go.  Asensus Surgical’s Senhance garnered a collection of FDA approvals in 2021 and J&J plans to start clinical trials of its Ottava robot in 2022. To add to Intuitive’s competitive pressures, ION, its new bronchoscopy robot faces significant competition in J&J’s Monarch. Finally, Intuitive has been facing a steady expiration of 20-year patents on Davinci since 2016, which will accelerate in 2022. 
6. Device and diagnostic companies, having transitioned to generating value via data as well as devices, can expect renewed federal scrutiny on cybersecurity and increasing pressure on data security capabilities. The MedTech industry continues to see an evolution in the collection, amalgamation, and analysis of healthcare/patient data to drive value and innovation. As software itself becomes a more common medium for medical devices (SaMD), and as AI/machine learning in medical devices expands, expect the FDA to press hard on how to best regulate this technology. The recent creation of the FDA Digital Health Center for Excellence is yielding results as policies are adapted to track closer to industry innovations, including the Digital Health Software Precertification Program. However, health data is sensitive, and privacy and security must be protected. Given that many MedTech manufacturers now collect, store, and analyze patient data as a service to their patients and clinicians, they are on the hook for ensuring its safety and security. 
7. The CURES 2.0 bill, introduced in late 2021, brings renewed hope for Medicare Coverage of Innovative Technology (MCIT). MCIT was developed to accelerate medical research and patient access to novel therapeutics by granting expedited Medicare coverage for up to four years for certain FDA-designated “breakthrough” devices. CMS rescinded MCIT in November 2021, to the distress of companies whose devices had qualified for coverage, over concern that coverage could not be terminated if it was subsequently determined that the technology "offers no clinical benefit" or "causes, or may cause, serious harm."  A new paragraph in the CURES 2.0 bill specifically states that nothing shall restrict HHS from using existing authority to suspend or terminate coverage of a breakthrough device. There is no guarantee that this will be enough to resurrect MCIT, or that the CURES 2.0 bill will pass, however, it provides some hope to MedTech innovators as 2022 kicks off. 
8. Expect to see increasing acceptance and utilization of Real World Evidence (RWE) in 2022. A plethora of new guidance/legislations around the globe demonstrates the commitment of regulators to use high quality relevant and reliable RWE for regulatory decision making, including additional requirements for post-market surveillance like post-market clinical follow-up studies on safety and performance. In addition, manufacturers will also start to look at how RWE can be used to inform strategies to enhance study design, study planning, and patient enrolment that will allow them to effectively conduct their safety studies to meet the needs of regulators. Finally, regulators are opening to more innovative study designs using RWE with a focus on applying a targeted approach to answer the relevant research questions.
9. Despite all the fanfare of 2021 around telehealth, it appears that telehealth overall will remain under 10% of office visits in 2022, with primary use cases in mental health, rural patients without close access to a doctor, and those too infirm to travel. The shifts in telehealth regulation and reimbursement, put in place during the pandemic to make access easier, are expected to be made permanent in 2022. However, telehealth as a percent of all office claims dropped to ~8% by the end of 2021. While this represents a significant increase from the ~1% it claimed before the pandemic, it is quite a drop from the ~30% of visits conducted via telehealth during the height of the pandemic in 2020. Further, the number one telehealth claim continues to be for mental health, just as it was before the pandemic. This indicates an ongoing preference among patients and clinicians for in-person visits, where diagnostic tools and tests, in addition to a clinician’s ability to see, touch, hear and feel, can be utilized.
10. In 2022 and beyond, MedTech manufacturing will need to look more aggressively into reducing its contribution to waste and consider incorporating biodegradable materials, reducing packaging waste, and perhaps even innovating around sterilization technology to enable reusability. The MedTech industry is awash in disposable plastic packaging and products. While these products bring several important benefits like sterility, lower costs, and engineering advantages, they also contribute, some say significantly, to the overall waste stream. Historically, the focus of waste discussions has been on the hospital and the disposal of medical waste, given its potential to spread disease. But conversations are slowly turning to focus on the plastic waste hospitals are producing every day (e.g., hundreds of millions of IV bags and tons of plastic products and packaging). The MedTech industry has made strides towards improving the recyclability of its products, but given that recyclables often end up as trash, this may not be enough.