中国国际医疗器械设计与制造技术展览会(Medtec China)2021

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2022年12月7-9日 | 苏州国际博览中心B1-E1号馆

What Will 2022 Hold for Medtech?

2022-01-11

For our look ahead at medtech in 2022, we've gathered some insights from across the medical device and healthcare industries. Read on for perspectives about 2021 and expectations for 2022, and please feel free to offer your own in the comments.

We kick off our review with a little optimism:

"While our healthcare system has unbelievable challenges, I think it’s always important to stop and look around and just look at how amazing everything is," shares Justin Barad, MD, CEO & Co-Founder of Osso VR. "We are witnessing almost daily miracles with the types of technologies we have access to, the incredible people behind them whether they're providers or in industry and the innovations that are coming down the line. I think the single most important thing for us to continue to do is to bring a sense of positivity and excitement into this space and mutual support, both between industry and healthcare institutions in order to battle burnout and preserve the morale of those who care for us and those who provide the means to do so. I am and will continue to remain incredibly optimistic about our future in healthcare!"

Here's to a healthy and productive 2022!


Pandemic Persisting Longer Than Anyone Could Have Imagined

Last year at this time we were looking foward to a post-COVID-19 world, so it's hard to believe we are kicking off 2022 with spreading Omicron variant cases and a resulting pause in elective procedures, among other impacts.

"I think the one trend that is likely obvious is the persistence of the pandemic," Justin Barad, MD, CEO and cofounder of Osso VR, tells MD+DI. "While many in the industry predicted this could go on for more than a year, I think few predicted we’d still be facing unstable elective case volume and continued difficulty with in person interactions to this level."

Consequently, Barad expects to see "a more rapid and mature shift to digital transformation (you could even say a partial transition to the medical metaverse). Some examples of this include rapid expansion of our own VR training platform and other remote proctoring solutions such Proximie, Avail Medsystems, and ExplORer surgical (which was recently acquired by GHX)."


Supply Chains May Still See Some Struggles

“Supply disruptions are going to carry over from 2021 to 2022,” predicted Michael Muchin, general manager, North America, Avery Dennison Medical. “Demand is coming back for the industry, but while inventory levels are slowly rebounding, supply challenges are impacting the delivery of materials. This market dynamic has created a perfect storm. It’s a very challenging supply environment across the medical sector.”

Scott Herskovitz, president and chief executive officer of Qosina, also expects to see supply chain issues along with labor shortages in 2022. “There are still material shortages resulting from chemical plant explosions as well as labor shortages and sickness that continue to impact every company,” he explained. As a result of these challenges, he is concerned about overbuying, which could lead to crucial products being taken out of the economy that might be needed for others.

His advice? “Get orders in early and communicate forecasts.”

Herskovitz also acknowledges that “for medical devices, it is hard to replace components because they could be specified in 510(k)s—but not all products are like that. If companies are able to consider alternative components, we stock a wide selection with similar functionalities.”

Avery Dennison is working with its customers "to accurately forecast demand and to accept forward orders so that we limit supply disruptions,” Muchin added. “We are also collaborating closely with our global supplier network. As part of Avery Dennison Corp., we are fortunate to have strong relationships with large suppliers. That relationship has helped us secure raw material allocations when supply was constrained. Ultimately, it’s been a combination of us working closely with our customers and suppliers to source the right inventory at the right time.”

Kevin Young, vice president of corporate development at Web Industries, believes that "supply chain issues run deep. They include concerns over sourcing reliability from the Far East and the cost of shipping. These are typically global dynamics over which no company has total control. Finding supply sources that can mitigate them should be uppermost in medical device producers' minds. Regional contract manufacturers exist in North America and Europe that can accommodate fluctuations in demand and do not depend on overseas transport to meet delivery schedules. Depending on a medical device manufacturer's volume and timing needs, outsourcing to regional contractors may be a suitable alternative to the supply processes manufacturers currently have in place." The company is a contract manufacturer for assembling COVID test kits and a converter of PPE used in the medical industry.


Manufacturing Employees May Still Be Hard to Come By

The "Great Resignation" was a force in the general U.S. labor market in 2021, and as a result experts expect to see significant job opportunities in 2022, including in U.S. manufacturing. There may be several factors driving such trends, and employers are responding in innovative ways, according to the Texas A&M University professor who named the trend, Anthony Klotz.

The situation is challenging for employers, however. Web Industries's director of market development Ralph Tricomi told MD+DI that "labor shortages at the docks and in the trucking industry are negatively affecting the supply chain but are an equally significant challenge on the manufacturing floor. More than any time in decades, good machine operators, maintenance professionals, operations, and warehouse people are hard to find. It is taking a lot to attract talent. At Web Industries, we've been aggressive in our recruitment tactics with discretionary benefits, flexible hours, and boosts in entry-level and performance pay, and we are tapping outside agencies to a larger extent than in the past.”


Healthcare Systems Still Under Pressure

“While COVID-19 will continue to place a huge strain on the healthcare system in 2022, the rise of chronic diseases will also add significant pressure,” shared John O’Gorman, product innovation manager, S3 Connected Health. “Currently, chronic diseases are the leading cause of death and disability worldwide and are one of the biggest drivers of health costs. Their prevalence rose 57% in 2020, with more growth expected next year, and that means we’ll need to see an increased focus on preventive care to treat chronic diseases. But preventive care goes beyond just treating diseases. With the help of digital tools, it encourages the adoption of healthy lifestyles to stop chronic diseases before they emerge, and monitor at-risk patients to identify symptoms as early as possible."

O’Gorman also pointed out another challenge we’ll see in 2022—managing increased demand for hospital beds. “This pressure stems from an aging population that requires more in-hospital care, repeated waves of COVID patients that require specialized care, as well as a need to treat rising number of chronic diseases sufferers. Predictive analytics will be critical for helping hospitals manage demand by improving the flow of patients through medical facilities and minimizing overcrowding in emergency rooms.

“Finally, due to our growing population—as well as issues mentioned above, and increased service price—healthcare costs will continue to rise. The best way for hospital and healthcare systems to manage these costs is to reduce the impact of administrative bottlenecks and costly avoidable readmissions, by securing the flow of information. Investing in tools that boost interoperability will be crucial to effectively managing these data flows.”

Complicating these longer-term pressures is a hospital staffing shortage as 2022 kicks off. Analysts are hopeful this is a short-term situation, but it may impact elective procedures.

The above picture features a crowded hospital emergency room in New York City during the beginning of the second year of the COVID-19 pandemic.


Digital Health Will Continue to Transform Medtech

Digital health was one of our 2021 medtech wins, and we've marveled at its ascent in 2019, 2020, and 2021. And it just continues to explode, supporting other trends in telemedicine, remote patient care, home care, connectivity, and data-driven healthcare.

The pandemic has helped propel digital health technology. "Prepandemic . . . there were a lot of conversations about software as a medical device and interoperability and things like that. But what's accelerated digital health technology and digital transformation is the fact that so many stakeholders are now accelerating the technology and their initiatives because of the way we are operating today, much more remotely, whether its telemedicine or patient engagement with physicians," explained Joe Sapiente, VP of Clinical Science and Technology for the Medical Device Innovation Consortium, in an online BIOMEDevice session. "It's definitely not a fad, and it's really picked up in terms of pace and timing." The MDIC is exploring the convergence of connectivity, information, and software in its new Digital Health Initiative. The consortium has several active programs on software as a medical device, software in a medical device, mobile medical applications, interoperability, wireless medical devices, patient-generated data, and in-silico validation/modeling.

John Mulcahy, vice president, products, S3 Connected Health, says that “while 2021 saw the mainstream adoption of remote healthcare models as a result of pandemic, 2022 will see the emergence of new care pathways that continue to leverage digital solutions as part of mainstream care. These include devices to capture objective patient data, and machine learning to deliver insights to patients and doctors at the point of care.

“As we manage new variants of COVID-19, healthcare will continue to oscillate between in-person and remote-care models," he continued. "2022 will nevertheless see us move towards a more permanently digital approach to healthcare, and this will also extend into pharma, where decentralized trials enabled by technology will gradually become the norm.

“Many companies will continue to create point digital health solutions, but adopting a platform approach is undoubtedly on the cards," predicts Mulcahy. "Digital health platforms will serve as a foundation on which digital health solutions can be created and deployed quickly across devices and therapy areas. Solutions created on these platforms support features like digital health enterprise software, behavior science, data science, and medical devices. Adding these can help provide data-driven behavior feedback loops, offer support to patients and their care teams, and, crucially, enable highly engaging and personalized care.”

The Rise of Digital Therapeutics


“I believe, in 2022, medical device companies will increasingly adopt digital therapeutics (DTx) to build out their existing device-based offering,” predicts Bill Betten, director of solutions, S3 Connected Health. “DTx have been popular with pharma for some time but the most prominent in the market have been standalone software products, with many focused on mental health, for example.

“But DTx are much more," he told MD+DI. "Device combination DTx are gaining popularity and offer a real opportunity to improve core device offerings. Philips has recently joined the Digital Therapeutics Alliance, expanding their membership beyond pharma and pure-play digital therapeutics companies and hinting at a change in this market.

“Ultimately, medical device vendors and healthcare in general stand to gain by adding a software element to device-only offerings in order to maximize their potential, unlock data, and turn it into actionable insights," he says. "These insights help drive competitiveness, enhance interoperability, and enable secure reimbursement in leading markets where DTx are prescribable, such as Germany and Belgium in Europe. Crucially, the ability of DTx to gather clinically validated data is set to help clinicians improve the quality of care they deliver, leading to better patient outcomes."

3D Printers May Be Pumping Out More Medtech

3D printing was also one of our 2021 medtech wins, and the progress keeps building. Formlabs just gained a major contract from group purchasing organization Vizient. “The inclusion of the Formlabs technology ecosystem in the Vizient catalog signals an inflection point for 3D printing in the healthcare industry,” stated Gaurav Manchanda, director of medical market development at Formlabs, in a news release. “As the first 3D printing company to be listed in the largest and most prominent GPO catalog in the country, Formlabs has solidified its position as the leader driving adoption of 3D printing for precision surgery.”

Also kicking off the new year with good news is 3DEO, reporting significant growth in 2021 and its plans to add 44 additional printers into production in 2022. In July 2021, for instance, 3DEO shipped its millionth customer part, positioning the company to ship 1.3 million parts in total while penetrating new markets like surgical devices and others, the company shared in a news release.

Adoption of new and disruptive technologies such as 3D printing typically occurs at a more gradual pace, acknowledges Menno Ellis EVP, Healthcare Solutions, for 3D Systems. "With that in mind, we see good continuation and acceleration of current trends into the next year; many of which point towards the increasing use of 3D printing in the space. . . . We are seeing 3D-printed patient-matched surgical tools and implanted devices become more broadly adopted as benefits are demonstrated through an increasing number of clinical studies that are performed by both commercial and education groups. We expect adoption to be further spurred by technical advancements in 3D printing that will enable cost-effective solutions across larger parts of the human anatomy.”

The pandemic may have accelerated progress a bit. “As COVID has confronted companies worldwide with supply chain constraints, this has served as a further catalyst for leading-edge medical and dental point of care providers to bring the production of implants and appliances closer to the patient," Ellis says. "The capabilities and economic benefits of 3D printing solutions are well suited to these initiatives, and we expect increased activity in this space.”

Dr. Brent Stucker, 3D Systems' chief scientist, additive manufacturing, expects to see "new polymer and metal materials designed for more rigorous use-case environments" as additive manufacturing moves more and more towards production applications. "I believe companies will also begin to introduce new 3D printers designed for specific applications, part sizes, or material offerings. This will result in more cost-effective solutions for production applications rather than the more generic multi-material, multi-application prototyping machines of the past. Underlying these new printers, I think we’ll also see improved software and machine monitoring solutions announced, such that machines will monitor their health and notify operators when things are going wrong and/or start correcting for errors automatically. I also expect AM users to migrate to complete software platforms focused on AM – versus collections of individual software products. This can provide customers more functionality under one software platform rather than needing to jump around between software tools to accomplish their goals.”

And Dr. Jordan Miller, 3D Systems's chief scientist, regenerative medicine, expects to see “an acceleration in how bioprinting is influencing the field of regenerative medicine. As we enter 2022, I believe the innovation in materials, and printing technologies will play a pivotal role in what is accomplished in the coming year. While there have been many players attempting to enter the field, commercial successes of biofabrication technologies such as biomaterials extrusion and photolithography are enabling advanced research and development. The deployment of these solutions is helping researchers maintain data integrity and improve reproducibility. As a result, the scope and depth of the biological investigations are getting better, which in turn is promoting new foundational studies to uncover a novel mechanistic understanding of physiology (i.e., healthy tissue) and pathophysiology (i.e., injured or diseased tissue). The advancements in and availability of these solutions are yielding a rapid increase in the number of papers published as the technology becomes easier to use – helping the entire regenerative medicine community get closer to our goal of implantable human tissues and organs.”


Robotics and Other Advanced Medtech Will Continue to Make Gains

In 2021 we saw the number of robotic-assisted procedures performed worldwide using the da Vinci surgical system exceed 10 million. The milestone demonstrates the significant role robotics is already playing in healthcare, and the increasing efforts of emerging robotics innovators promise much more is yet to come. As we point out, Verified Market Research expects the global robotic surgery market to hit $22.27 billion by 2028, up from $6.1 billion in 2020.

And a study by Juniper Research predicts that smart hospitals will deploy 7.4 million connected IoMT devices globally by 2026, growing 231% over 2021, during which 3.2 million devices were deployed. IoMT devices include surgical robotics as well as others such as remote monitoring sensors.

"I think we can safely say that enabling technologies are here to stay. The ubiquity of robotic and navigation systems and their rapid evolution paired with surging patient demand are paying off for a lot of the early bets in this space," shares Justin Barad, MD, CEO and cofounder of Osso VR. "There are still many challenges and we are still awaiting that moment where we get overwhelming data around the assumed value proposition but you cannot deny that we are approaching enabling surgical technologies as a standard of care in the near future."

Pictured in the above image from 2020 is Jürgen Weitz, director of the Clinic for Visceral Surgery, at the Carl Gustav Carus University Hospital in Dresden, during a press appointment in an experimental operating room working on a da Vinci surgical system for minimally invasive surgery.


Ambulatory Surgery Centers Will Continue to Flourish

"Another trend I am seeing is the acceleration and success of the ambulatory surgical care model," shares Justin Barad, MD, CEO and cofounder of Osso VR. "The things driving this are higher quality patient and provider experiences, higher margins, and decreased need for utilization of inpatient resources."

Not all devices and technologies are necessarily suited for the ASC model, says Barad. "But you’re seeing many new devices or device modifications come out that tailor themselves for the evolving market dynamics," he explains.

MD+DI has been tracking ASC growth in recent years as well as the lasting impact the pandemic may have on where surgeries are performed.


Healthcare Will Demand Faster Diagnostics

"Due to the anticipated rise in frequency of disease outbreaks, and the public’s demand for faster diagnoses, the healthcare systems will demand faster more sensitive quantitative easily scalable testing platforms," Marwan Alsarraj, BioPharma Segment Manager at Bio-Rad Laboratories, shared with MD+DI.

Alsarraj says that digital PCR is one of these platforms. "While qPCR has become the standard technology used for COVID-19 testing, the superior sensitivity and accuracy of ddPCR is clear. ddPCR technology uses a combination of microfluidics and proprietary surfactant chemistries to divide PCR samples into tens of thousands of water-in-oil droplets and run individual endpoint reactions to quantify the concentration of nucleic acids in a sample. ddPCR surpasses the performance of earlier digital PCR techniques by resolving the previous lack of scalable and practical technologies for digital PCR implementation. Implementing ddPCR on a wider scale will increase the reliability of infectious disease testing."

Alsarraj also believes that the increasing role of ddPCR as a molecular diagnostic will help feed a rise in demand for faster, more personalized molecular diagnostics for cancer. "The clinical management of cancer has evolved in recent years towards more personalized strategies that require a comprehensive knowledge of the complex molecular features involved in tumor growth and evolution and the development of drug resistance mechanisms leading to disease progression. Meanwhile, physicians are discovering that diagnostics and treatment regimens are influenced more by the genetic mutations associated with cancer than the organ in which the first tumor appeared. ddPCR has become one of the most accurate and reliable tools for the examination of genetic alterations in a wide variety of cancers because of its high sensitivity and specificity. ddPCR is currently being applied for absolute allele quantification, rare mutation detection, analysis of copy number variations, DNA methylation, and gene rearrangements in different kinds of clinical samples."


The Need for Cybersecurity Heightens

It only takes a few minutes browsing the Industrial Control Systems advisories from the Cybersecurity & Infrstructure Security Agency (CISA) to get an idea of the number of cybersecurity risks lurking in medtech.

Legacy medical devices face a number of risks, according to GlobalData. “The knowledge that many of our most critical devices are legacy devices and therefore too old to update is concerning,” shared Alexandra Murdoch, medical device analyst at GlobalData, in a news release. “The availability to update a device could be crucial to preventing cyberattacks. It’s important for patients’ safety that the industry invests in newer devices that will perform regular security updates.”

However, there are also risks as more and more connected devices come to market. “A Deloitte study expects that connected devices in health care systems will grow to 60-70% over the next five years. Devices that are retired will be replaced with newer, connected ones. As the number of connected devices grows, so too will the disruptions to patient safety," Doug Folsom, president, cybersecurity and chief technology officer, TRIMEDX, told MD+DI. "The danger of device hacks in causing the inability to treat patients is a growing risk, and one that cannot be overlooked. In 2022, there must be a real effort from healthcare systems to strengthen their network security through robust cybersecurity efforts."

Healthcare systems will need help to minimize all these risks. “The best solution is for hospitals and healthcare systems to implement a comprehensive cybersecurity solution that not only scans their network for vulnerabilities but also integrates with their central maintenance management system and ties all that data together, so they can best protect medical devices used for patient care," explains Kristi McDermott, president, clinical engineering at TRIMEDX. "In 2022, I believe having a comprehensive cybersecurity solution along with trained, professional clinical engineering leadership with trained technicians in that space are going to be required to protect the core mission of a healthcare system.”


Remote Training May Fill Ongoing Needs

Chris Luoma, senior vice president, global product management, GHX, sees a continued focus on remote training. "With the abundance of innovation and new medical devices and technologies in healthcare, the need for extensive training for surgeons is becoming more and more necessary. With continued restrictions on who can enter the operating room, there needs to be a remote training option to assist in training medical device sales reps and surgeons," he tells MD+DI.

Justin Barad, MD, CEO and cofounder of Osso VR, agrees. "The need for remote learning and training existed pre-pandemic and with the persistence of new variants there is an accelerating need for remote training and assessment," he says. "Initially the concern was that trainees such as residents and fellows were falling behind given decreased case volume and sick leave. But now we are starting to see a worrisome trend of burnout and early retirement, especially in the nursing space. We need to secure our supply chain with a more efficient and rapid process to develop our HCP workforce in addition to ensuring a minimum level of proficiency that can provide consistent and outstanding outcomes for patients."

Luoma mentions Explorer Surgical, a cloud-based platform that helps reps and doctors remotely join surgeries to train on them from anywhere in the world. "They have experienced tremendous success in the past year as remote training options prove to be a permanent solution for giving surgeons and reps access to the OR," he explains.


Medtech Interest in Sustainability Is Blooming

Sustainability is on the minds of medtech. Signia, a manufacturer of hearing aids, for instance, decided to study the environmental impact of hearing aids. It commissioned a life cycle assessment (LCA) comparing the lifetime environmental impact of rechargeable and non-rechargeable hearing aids and found out that the rechargeable Signia Augmented Xperience (AX) reduces the total environmental impact by 65% compared with the non-rechargeable Signia AX. A user with two hearing aids can save more than 100 batteries per year. The study was conducted by Ramboll and audited by the accredited certification body TÜV NORD.

“At Signia, we are committed to continually improving our environmental footprint, and the biggest lever we have identified is the battery. We want our customers to be aware of how easy it is to positively influence the environmental impact, just by switching to rechargeable hearing aids,” shared Frank Naumann, senior director of global innovation at Signia, in a news release.

Signia isn't the only medical device company interested in sustainability. Stryker just joined the Healthcare Plastics Recycling Council, a group working to promote plastics recycling. “We are working to improve healthcare responsibly and sustainably because we believe the health of the world is as important as the people who live in it,” said Erol Odabasi, director, corporate sustainability at Stryker, in a statement on HPRC's site.

Other companies joing the HPRC last year included PAXXUS, Westfall Technik, Sonoco Healthcare, Sartorius, Sterimed, and Freepoint Eco-Systems.

And the past year saw Kilmer Innovations in Packaging set out to improve the sustainability of medical device packaging. “We have a huge opportunity here to broaden our horizons and really make an impact with respect to sustainability,” shared Jenn Goff, global director of product strategy for Oliver Healthcare Packaging.


Demand for Single-Use Components for Bioprocessing

The rush for a COVID vaccine demonstrated the benefit of single-use systems for vaccine development,” notes Scott Herskovitz, president and chief executive officer of Qosina. “A bioreactor can now be used for one vaccine lot and then disposed of, and a new one quickly started for another production run.”

Herskovitz said that Qosina “is happy to serve as a secondary source for these components for companies qualifying multiple components to avoid supply chain issues.” The company offers bioprocessing components for single-use systems with cleanroom packing and quality inspection.


Inflation Hitting Manufacturing

"Compounding the difficulty in the overall 2022 business equation is inflation,” shared Ralph Tricomi, Web Industries's director of market development. “Costs for electricity, fuel oil, everything you need to run a plant, it's all spiking.

"Every year has its own set of challenges, but it appears that 2022 will present an especially complex business environment. Medical device manufacturers will need to adjust some existing practices to navigate it effectively," he advises.

Article source: Qmed and MD+DI