Top 10 Trends in The Global Medical Device Industry in 2022

As the COVID-19 outbreak eases globally, favorable trends in the  medical device industry, such as aging, will regain attention. However, global cost pressures remain, and the pay-for-service model will decline, replaced by a pay-for-efficacy and risk-benefit model.In addition, national new policies such as centralized procurement of medical devices in China will bring huge pricing pressure and further reduce product profits. Here are ten trends to watch in the medical device industry in 2022.① Regulatory policies are becoming more and more strict, and the regulatory environment is full of variablesThe European Union Medical Device Regulation (EU MDR) has entered the first full-year implementation phase, and the IVDR (In Vitro Diagnostic Medical Device Regulation) will be officially implemented from May 2022. Although the transition time has been extended, the equipment to be evaluated will be implemented after the implementation of the IVDR. The review must be completed, and a number of issues remain. Before the IVDR promulgated new device classification standards, only about 20% of in vitro diagnostic devices (IVDs) required mandatory conformity assessment by notified bodies, and now this rate has increased to about 80%.Although the number of designated certification bodies will increase in the second half of 2022, medical device and in vitro medical diagnostic device manufacturers will still face enormous challenges, both from clinical (effect evaluation) requirements and market requirements on the other.While manufacturers are increasingly adapting to EU regulations, in 2023 they will start preparing for the UK Mandatory Conformity Standard , which will be required for all equipment entering the UK market from June 2023 onwards.②The epidemic and digitalization drive continuous changes in sales and servicesThe rapid transformation of marketing, sales, training, and services to online models not only provides clinicians and medical institutions with more choices and convenience, but also improves the efficiency of manufacturers. There is no doubt that certain free support services for hospitals and physicians will continue to exist (eg, complex surgical support and training in the use of equipment). Numerous studies have shown that both clinicians and sales reps prefer virtual interactions to maintain customer data coherence, thereby enhancing customer relationships and increasing customer satisfaction.However, virtual interactions will put pressure on medical device manufacturers that were not originally "first movers" in digital innovation, pushing them to build a customer-centric digital marketing system that caters to a range of customer sales, training, service, inventory management, and more demand.③In vitro diagnostics and traditional diagnostic tool innovation go hand in handOn the one hand, the field of point-of-care testing will continue to change and expand because the pandemic has put enormous pressure on in vitro diagnostic companies to develop point-of-care tests. On the other hand, telemedicine is limited by remote diagnostic capabilities. There are still many limitations in remote diagnosis, such as inspection of eyes, ears, and throat; auscultation of lungs; measurement of body temperature; observation of skin paleness, evaluation of sweating, and examination of rashes. In 2022, clinically reliable home testing tools will develop further and may eventually become as ubiquitous as thermometers.④The acceptance of digital therapy and digital care tools is gradually increasing, and will continue to strive for inclusion in medical insuranceOver the past five years, nearly 1,500 studies have provided a range of clinical evidence confirming the app's effectiveness. In addition, at least 25 digital therapeutics (DTx) products have been approved by regulators and another 23 products are on the market. But digital therapeutics are few and far between, and they often include some related components for treatment, such as Propellor Health for asthma and chronic obstructive pulmonary disease and Livongo for diabetes. Some employers offer flexible spending account (FSA) benefits to employees for some high-cost medical conditions, such as diabetes, obesity, and chronic obstructive pulmonary disease.However, payers are still hesitant, in part because such digital tools are too new for their services to be effectively integrated into the current health care system. In addition, it is difficult to demonstrate cost-effectiveness to payers for an entirely new product or therapy (eg, the product does not replace an existing product) . Finally, digital tools themselves, as a concept, are difficult to pay for in terms of costs and/or outcomes over the long term . For these reasons, combined with a lack of robust evidence, the long road to digital tools inclusion in health care will be fraught with difficulties.⑤The competition in the field of surgical robots will be fiercer than everIn the past 10 years, the successful commercialization of surgical robots has been limited to areas where Intuitive Surgical's "da Vinci" robot does not dominate (eg: orthopedic surgery). However, "Da Vinci"'s 20-year patent has been invalidated since 2016, and this process will intensify in 2022. Several surgical robots will be able to compete head-to-head with "Da Vinci" in its main field , and It has advantages in cost, size and haptic feedback. Such products have been approved and put into use in markets outside the US and are now targeting the US market.Perhaps the most eye-catching of these is the long-awaited Medtronic HUGO soft tissue robot . In addition to obtaining CE certification and medical device registration with Health Canada, HUGO has also obtained an FDA investigational device exemption by the end of 2021.Versius , a British surgical robotics company (CMR Surgical) , has raised $600 million in 2021. In November of the same year, Brazil became the 11th country to introduce the system. In the U.S., the Versius system is currently under FDA approval, and its commercial team is ready to go.Asensus Surgical's Senhance surgical robot has passed a series of FDA approvals in 2021; Johnson & Johnson plans to launch a clinical trial of the Ottava surgical robot in 2022.It's not just that, Intuitive Surgical's newly released bronchoscopy robot, ION, is facing a huge challenge from Johnson & Johnson's Monarch robot.⑥ The ability of data to create value is increasingly prominent, but it will also face a re-examination of securityThe medical device industry continues to advance in the collection, consolidation and analysis of medical or patient data to drive value and innovation. However, as software increasingly becomes the medium of medical devices, artificial intelligence or machine learning is further developed, due to the high sensitivity of medical data, and at the same time, many medical device manufacturers provide patient data collection, storage and analysis as a service to patients Or doctors, so manufacturers must keep data safe.How to better regulate this technology will be the focus of FDA's next work. In order to promote the supervision of innovative technologies, the FDA has newly established the FDA Digital Health Center for Excellence and launched the Digital Health Software Precertification Program.⑦ CURES 2.0 (21st Century Cures Act) Brings New Hope for Restart of Medicare Coverage for Innovative Technologies (MCIT)MCIT grants medical devices with FDA Breakthrough Device Designation expedited medical coverage for up to 4 years to accelerate medical research and improve access to innovative medical outcomes. But the Centers for Medicare and Medicaid (CMS) has doubts: CMS cannot terminate Medicare reimbursement eligibility for a device that proves to not provide clinical benefit or (potentially) cause serious patient harm.As a result, MCIT will be terminated in November 2021. That worries companies whose devices are covered by health insurance. Unlike MCIT, CURES 2.0 clearly states that the U.S. Department of Health and Human Services (HHS) has the authority to suspend or terminate the eligibility for Medicare reimbursement for breakthrough devices.⑧ The acceptance and utilization of real world evidence (RWE) will be further improvedA plethora of new guidelines/legislation around the world demonstrate that high-quality, relevant, and reliable real-world evidence (RWE) has been widely adopted by regulators to support regulatory decision-making, including post-market surveillance such as clinical studies monitoring safety and efficacy.As a result, manufacturers are also beginning to examine how RWE can be used to develop strategies to optimize study design, study planning, and patient enrollment to effectively implement safety studies to meet regulatory needs. Finally, regulators are receptive to innovative study designs that utilize RWE and focus on specific experimental approaches to address relevant research questions.⑨ The proportion of telemedicine will fall back to the pre-epidemic levelThe COVID-19 pandemic has driven regulatory and reimbursement reforms for telemedicine to facilitate patient access, however, by the end of 2021, telemedicine’s share of total hospital visits has dropped to 8%. Although this proportion has increased significantly from about 1% before the epidemic, it has dropped significantly from nearly 30% in 2020 when the epidemic was at its worst.In addition, telemedicine still primarily serves psychotherapy, as it was before the pandemic. This phenomenon shows that patients and doctors prefer face-to-face consultation. In the outpatient clinic, physicians can perform inspection, palpation, auscultation, and use of tests and examination tools.⑩ Efforts to reduce medical waste still need to be strengthenedCurrently, the medical device industry uses a large amount of single-use plastic packaging and products. While these products have many advantages, such as sterility, low cost, and ease of manufacture, they also generate large amounts of medical waste. In the past, discussions about waste have revolved around medical waste disposal in hospitals because of the risk of spreading disease.However, the conversation is now turning to the plastic waste that hospitals generate on a daily basis (eg, thousands of IV bags, tons of plastic products and packaging). The medical device industry has made some progress in improving product recyclability, but current progress may still be insufficient given that recyclables often still end up as waste. Therefore, consider biodegradable materials, reduce packaging waste, and even innovate in sterilization technology for reuse.https://www.arshinemedical.com...