10 Key Medtech Themes for 2023

https://medcitynews.com/2023/01/10

We expect 2023 to be a pivotal year for the industry, as the accelerated acceptance of virtual care and demographic trends, such as an aging population, increasing chronic illnesses and healthcare worker shortages, sustain demand for medtech-enabled solutions.

The combination of rapid developments in novel healthcare technology and heightened demand for integrated tech-enabled care has continued to fuel innovation in the medtech industry.  At the same time, medtech innovators – whether in digital health, wearables and AI-driven offerings in healthcare, or diagnostics, telemedicine and health IT solutions – continue to face a patchwork of laws, rules and norms across the world. Life sciences and healthcare innovators and regulators are also looking to medtech to increase access to care and health equity. Here are ten global medtech themes we are tracking in the coming year:

Focus on digital tuck-in acquisitions in medtech M&A

Despite continued uncertainty in the overall financial market, medtech M&A activity continued at a steady pace in 2022.  This year witnessed a rise in tuck-in acquisitions of smaller companies that can be easily integrated into buyers’ existing infrastructure and product offerings, as opposed to significantly sized takeovers of businesses that aren’t squarely aligned with buyers’ existing businesses lines.  Medtech acquirers have been particularly focused on developing their digital capabilities to innovate and reach customers in new ways.  As digitization continues to transform the industry, we expect acquirers to continue to prioritize the value of digital and data assets as they evaluate potential targets.

Continued interest by private equity and other financial sponsors

Private equity firms, healthcare-focused funds and other financial sponsors have continued to display a strong appetite for investing in Medtech companies, with top targets in subsectors such as diagnostics and healthcare IT solutions.  Later-stage medtech companies in particular are gaining a larger share of venture capital funding, as later-stage investments allow financial sponsors to focus on businesses with higher yields, as well as less time to market and capital reimbursement.  Demographic trends, including an aging population and the increasing prevalence of chronic diseases, coupled with healthcare technology advancements have created robust demand for medtech-enabled solutions.  Additionally, medtech offerings have broad applications that can extend beyond stakeholders in a specific therapy area, product category or care setting, offering the ability to satisfy unmet needs with large patient bases.

Strategic medtech collaborations as the new norm

Strategic medtech collaborations and partnerships have become the new norm in our increasingly connected digital healthcare ecosystem.  In response to heightened consumer demand for tech-enabled care, pharmaceutical and medtech companies are collaborating to use digital technologies to engage with consumers, unlocking a vast range of treatments such as personalized medicine.  Additionally, as the market rapidly evolves towards data-driven healthcare, we expect medtech companies to continue to work collaboratively to address existing barriers to data sharing and promote interoperability of healthcare data.

Continued scrutiny by antitrust and competition authorities 

As expected, global antitrust and competition authorities continued to focus on the tech, life sciences and medtech sectors in 2022.  The US, UK and EU authorities have stepped up efforts to investigate and challenge conduct by large pharma and technology companies pursuing mergers and acquisitions.  We expect these authorities to assess similar concerns in the digital health context in an effort to account for the value of combined datasets and the interoperability of various offerings that could be derived from digital health mergers and acquisitions.  Furthermore, geopolitical tensions have resulted in new and expanded foreign investment regimes to improve the resilience of domestic healthcare systems.  Notably this year, the UK government implemented the National Security and Investment Act that allows it to restrict transactions that may threaten national security, including in the AI and data infrastructure sectors.  Sensitive data continues to be a recurring theme for foreign investment review for Committee on Foreign Investment in the US  and that of the EU as well.

Growing importance of data privacy and security

Increasing regulatory attention to sensitive health data and the escalating rise of ransomware attacks has made data privacy and security more important than ever for medtech innovators.  The Federal Trade Commission has issued several statements about its willingness to “fully” enforce the law against the illegal use and sharing of highly sensitive data.  Additionally, several state privacy laws coming into effect in 2023 create new categories of sensitive personal data, including health data, and impose novel obligations on innovators to obtain data-related consents.  As ransomware continues to pose security-related threats, the US Department of Health and Human Services renewed calls for all covered entities and business associates to prioritize cybersecurity.  New standards, such as cybersecurity label rating programs for connected devices, aim to address security risks.  In the EU, medtech providers will need to consider how the launch of the European Health Data Space and newly proposed data regulation, such as the Data Act and AI Act, could impact their data use and sharing practices.

More active engagement with FDA/EMA/MHRA

We expect companies active in the medtech sector, particularly those that make use of AI and other advanced technologies, to continue their conversations with the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”), the Medicines and Healthcare Products Regulatory Agency (“MHRA”) and other regulators as such companies grow their medtech business lines and establish their associated regulatory compliance infrastructure. Given the unique regulatory issues arising from the implementation of digital health technologies, we expect the FDA, EMA and MHRA to provide additional guidance on AI/ML-based software-as-a-medical device and the remote management of clinical trials.  2022 saw stakeholders in the life sciences and medtech industries collaborate with regulatory authorities to push forward the acceptance of digital endpoints that rely on sensor-generated data collected outside of a clinical setting.  As the industry shifts to decentralized clinical trials, we expect both innovators and regulators to work together to evaluate the associated clinical, privacy and safety risks in the development and use of such digital endpoints.

Increasing medtech localization in the Asia Pacific region

2022 saw multinational companies (“MNCs”), including American pharma/device makers make an active effort to expand their medtech business lines in the Asia Pacific region.   At the same time, government authorities in the region have been increasingly focused on incentivizing local innovation, approving government grants and prohibiting the importation of non-approved medical equipment. In light of MNCs’ market share of the medical device market in the Asia Pacific region, especially in China, we expect the emergence of the domestic medtech industry to prompt discussions among MNCs, local innovators and government authorities over the long-term development of the global market for medical technology.

Long-term adoption of telehealth and remote patient monitoring technologies 

The Covid-19 pandemic saw the rise of telehealth and remote patient monitoring technologies as key modes of healthcare delivery.  The telehealth industry remains focused on enabling remote consultations and long-term patient management for patients with chronic conditions.  Looking forward, we expect to see increased innovation in non-invasive technologies that can provide early diagnostics and ongoing disease management in a low-friction manner.  At the same time, we anticipate telehealth companies to face increasing scrutiny from regulatory authorities around the world for fraud and abuse by patients and providers.  Consumer and patient data privacy and security in connection with telehealth and remote patient monitoring continue to remain top of mind for regulators as well.

Women’s health and privacy concerns for medtech

We expect to see increased consumer health tech adoption for reproductive care, especially in light of the U.S. Supreme Court’s decision to overturn Roe v. Wade.  Following the Dobbs decision, a number of states introduced or passed legislation that prohibits or restricts access to reproductive health services beyond abortion.  In response, women’s health-focused companies are expanding their virtual fertility and pregnancy, telemedicine and other services to patients.  At the same time, such companies need to assess the legal risks stemming from the collection and storage of their customers’ personal health information, which could then be used as evidence to prosecute customers for obtaining illegal reproductive health services.  We expect companies active in this space to take steps to navigate the patchwork of data privacy and security laws across jurisdictions while establishing clear digital health governance mechanisms to safeguard their customers’ data privacy and security.

Addressing inequities in the implementation of digital healthcare technologies

Medtech innovators and regulators have been increasingly focused on addressing inequities in the healthcare system and the data used to train AI and ML-based digital healthcare technologies.  In 2022, a number of medtech companies collaborated to provide technologies that result in improved patient outcomes across all populations, as well as boost participation of diverse populations in clinical trials.  In parallel, we are seeing increased interest from regulators to reduce bias in digital health technologies and the accompanying datasets, as evidenced by the EU’s proposed AI Act and the UK’s health data strategy. In the US, which currently lacks comprehensive government regulation of AI in healthcare, there have been increasing calls for institutional commitments in the area of algorithmovigilance.  Because of the inaccurate conclusions that may result from biased technologies and data, MedTech companies must prioritize health equity in the implementation of digital healthcare technologies so that everyone can benefit from the latest scientific advances.

In conclusion, the medtech industry has remained resilient amidst the challenging macroeconomic environment.  We expect 2023 to be a pivotal year for the industry, as the accelerated acceptance of virtual care and demographic trends, such as an aging population, increasing chronic illnesses and healthcare worker shortages, sustain demand for medtech-enabled solutions.  At the same time, the rapidly changing legal and regulatory landscape will continue to be a key issue for medtech innovators moving forward. Adopting a global, forward-thinking regulatory compliance strategy can help MedTech companies stay competitive and ultimately, achieve better outcomes for patients.

Oracle’s Acquisition of Cerner: The Future of Healthcare

https://blogs.oracle.com/healthcare/post/oracle-acquisition-of-cerner-the-future-of-healthcare

Prioritizing outcomes in healthcare is long overdue and now within reach following Oracle’s acquisition of Cerner. To achieve more seamless, coordinated care, technology must play a greater role in reframing solutions for health and well-being around the world.

Combining Cerner’s clinical capabilities with Oracle’s enterprise platform, analytics, and automation expertise will change health and wellness in a way that simply hasn’t been possible before. We’ll provide secure and reliable solutions that deliver health insights and experiences to dramatically change how health is managed by patients, providers, and payors. The industry has never been riper for change.

Designing for people

Healthcare is innately personal; however, the industry often loses sight of the human side of health as delivering and understanding care has become increasingly disconnected and complex. Research reveals that doctors spend nearly twice as much time on administrative work as they do engaging with patients. If we replaced clinicians’ time spent performing administrative tasks with patient interactions, imagine how dramatically we could improve quality of care. Technology-induced administrative burden contributes to burnout, which has, in part, resulted in a workforce shortage and overshadowed the true benefits of healthcare technology. Clinicians didn’t enter medicine to spend half of their time conducting routine tasks and completing required documentation; they chose their profession to practice at the top of their license. We’re working to make this a reality, providing a toolset that supports clinical decision making and prioritizes the user experience.

For care delivery organizations, we’ll develop new cloud-enabled capabilities allowing providers to access the information they need, where and when they need it, on an interface that is easy to use. This will significantly reduce the time and effort required to find a patient’s information, even if the information is scattered across different providers or care settings. We’ll help people access and manage their own health information from wherever they are, so that they have a stronger voice in their care and can conduct more meaningful conversations with their providers. When successful, these improvements ultimately increase the value of healthcare and have the additional benefit of contributing data to population health insights.

Collaborative, interoperable care

In a complex and inefficient healthcare industry, interoperability is critical; but, it hasn’t been widely adopted between organizations. From the patient perspective, data silos limit patients’ empowerment and involvement in their health and well-being. It is vitally important that medical records are portable. Regardless of where someone receives care, their records should be accessible and unified. From a clinical perspective, interoperability ensures clinicians can properly review a patient’s entire medical history within their workflow and provide appropriate, contextual treatment.

recent survey shows a staggering 97% of healthcare executives have called for increased healthcare data interoperability, the lack of which inhibits digital transformation and innovation within organizations and throughout the broader industry. Oracle is committed to open APIs to ensure any authorized user can consume health data and insights. We know a closed system will not create connectivity and unification across the many existing players and systems. Creating more solutions without an open ecosystem commitment would only contribute to the problems we see today with fractured and siloed systems.

Oracle will harness the power of data to create a collaborative ecosystem where people, patients, providers, and payors can securely access clinical, operational, and financial data on the cloud. These efforts will break down data silos and provide open systems that talk to—and connect with—one another to generate actionable, scalable, and global insights previously unavailable. Industry fragmentation impacts both patients and providers, but Oracle has the power to aggregate data into a single source of truth to achieve better outcomes.

Improved efficiency across the system

While enhanced clinical systems will improve experiences bedside and lead to better public health outcomes, back-office operations must also be improved to drive true efficiency, reduce costs, and make the business of healthcare more predictable. Oracle’s Fusion application suite can create this bridge between the bedside and the back-office, enhancing employee experience (better retention, less administration), streamlining the supply chain (reduced shrinkage, better inventory management), and giving the executive a better understanding of the issues impacting their business (greater predictability and cost control).

Secure healthcare data

Unfortunately, we know that retail, finance, and health data are the most targeted in security breaches. Patient privacy and the security of health data, when left unaddressed, threaten what the information of health exchange is solely meant to protect­­: patient safety. It’s time to raise health data security to an unprecedented level of investment and focus.

Oracle is an industry leader in securely storing, processing, and analyzing large volumes of cloud-based data. We’ll continue to apply the same security-obsessed focus to healthcare as we do to all industries, ­allowing people, patients, providers, and payors to safely access insights that improve care and advance decision-making. Oracle has been trusted with some of the world’s most sensitive and regulated data for more than 44 years. For the financial services industry specifically, Oracle already serves customers in more than 140 countries and manages risk for 24 of the world’s 28 systemically important financial institutions (SIFIs).

Meeting the moment

While we already knew this industry was ready for change, the pandemic amplified and accelerated the world’s readiness to see that change. We aim to meet this moment leveraging the technology and expertise that have revolutionized other industries, as well as applying new innovations to transform these systems of record into systems of intelligence.

Combining our existing healthcare industry solutions—from clinical trials to health insurance payor solutions to public health analysis systems—with our acquisition of Cerner, we believe Oracle has a uniquely positioned opportunity to offer new solutions to a broken healthcare system. We plan to support the entire lifecycle of healthcare, going beyond traditional health IT to integrate our infrastructure, platform, and applications capabilities for a more fully connected operational, administrative, and clinical system. 

We are fully committed to the partnerships that will be instrumental to this journey. The technology and the world are ready for transformation. This is just the beginning.

Healthcare hacking on the rise

https://mailchi.mp/ef14a7cfd8ed/the-weekly-gist-august-6-2021?e=d1e747d2d8

From the largest global meat producer to a major gas pipeline company, cyberattacks have been on the rise everywhere—and with copious amounts of valuable patient data, healthcare organizations have become a prime target.

The graphic above outlines the recent wave of data attacks plaguing the sector. Healthcare data breaches reached an all-time high in 2020, and hacking is now the most common type of breach, tripling from 2018 to 2020. This year is already on pace to break last year’s record, with nearly a third more data breaches during the first half of the year, compared to the same period last year.

Recovering from ransomware attacks is expensive for any business, but healthcare organizations have the highest average recovery costs, driven by the “life and death” nature of healthcare data, and need to quickly restore patient records. A single healthcare record can command up to $250 on the black market, 50 times as much as a credit card, the next highest-value record. Healthcare organizations are also slower to identify and contain data breaches, further driving up recovery costs.

A new report from Fitch Ratings finds cyberattacks may soon threaten hospitals’ bottom lines, especially if they affect a hospital’s ability to bill patients when systems become locked or financial records are compromised. The rise in healthcare hacking is shining a light on many health systems’ lax cybersecurity systems, and use of outdated technology.

And as virtual delivery solutions expand, health systems must double down on performing continuous risk assessments to keep valuable data assets safe and avoid disruptions to care delivery.

Deepening the role of Big Tech in analyzing clinical data

How Big Tech Is Changing the Way Hospitals Are Run | Technology Networks

HCA Healthcare, the nation’s largest for-profit hospital chain, which operates 185 hospitals and more than 2,000 care sites across 20 states, announced a landmark deal with search giant Google this week, aimed at extracting and analyzing data from more than 32M annual patient encounters.

The multiyear partnership will involve data scientists from both companies working together to develop care algorithms and clinical alerts to improve outcomes and efficiency. Data from HCA’s electronic health records will be integrated with Google’s cloud computing service, and the companies have pledged to adhere to strict limitations to protect individual patient privacy—a key concern raised by regulators after Google announced a similar partnership with another national health system, Ascension, at the end of 2019.

Despite those assurances, some experts pointed to this week’s announcement as further evidence that existing privacy protections are insufficient in the face of the deepening relationships between tech companies, like Google and Microsoft, and healthcare providers, who manage the sensitive health information of millions of patients.
 
We’d agree—we’re overdue for a major rethink of how patient privacy is handled. The healthcare industry spent much of the last decade “wiring” the health system, converting from paper records to electronic ones, and building vast storehouses of clinical data along the way. We’ve now reached a new phase, and the primary task ahead is to harness all of that data to actually improve care. That will require extensive data sharing, such as a recently announced initiative among several major health systems, and will also entail tapping the expertise of “big data” companies from beyond healthcare—the very same companies whose business practices have sometimes raised privacy concerns in the broader social context. But health information is different—more personal and more sensitive—than data about shopping preferences and viewing habits, requiring more rigorous regulation. 

As more big data deals are inked in healthcare, the question of patient privacy will become increasingly pressing.

The U.S. is way behind on coronavirus contact tracing. Here’s how we can catch up.

The U.S. is way behind on coronavirus contact tracing. Here’s how we can catch up.

The US is amassing an army of contact tracers to contain the covid ...

Get this: Vietnam, a country of 97 million people, has reported zero deaths from only 372 cases of coronavirus.

Theories abound about how they pulled it off. But public health experts chalk it up to swift action by the Vietnamese government, including contact tracing, mass testing, lockdowns, and compulsory wearing of masks.

Here, masks have become a political landmine. And despite President Trump claiming, “We have the greatest testing program anywhere in the world,” some states with surging infections have testing shortages—like Arizona.

But what about contact tracing, the process of calling potentially exposed people and persuading them to quarantine?

“I don’t think we’re doing very well,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, when asked in June about contact tracing nationwide. Most states haven’t even made public how fast or well they’re implementing the process, if at all.

Florida, the nation’s current No. 1 hotspot for the virus, is often failing to trace positive cases. This, despite the state spending over $27 million on a contract with Maximus, a company notorious for underbidding, understaffing, and performing poorly on government services contracts in multiple states.

Yet, there are bright spots elsewhere. California allocated 5 percent of staff across 90 state government departments to contact trace. North Carolina’s Wake County trained 110 librarians. In Massachusetts, counties have used state pandemic funds to hire more nurses.

There are three reasons why state and local governments should reassign public employees or hire new staff outright as the country—finally—ramps up contact tracing.

One, outsourcing what should be a public job to for-profit companies like Maximus reduces transparencylimits democratic decision-makinglowers service quality, and increases inequality, all while rarely saving public dollars. Public control is particularly important when it comes to contact tracing, which involves personal health data.

Two, this is a chance to begin to reverse decades of cuts to public health budgets, which have made the worst public health crisis in a century even worse. Almost a quarter of the local public health workforce has been let go since 2008. Federal spending on nondefense discretionary programs like public health is now at a historic low.

The Trump administration, as expected, is headed in the wrong direction. On Tuesday, it stripped the Centers for Disease Control and Prevention (CDC) of control over coronavirus data. State and local governments must do all they can to right the ship.

And three, contact tracing is an opportunity to chip away at systemic racism. Since World War II, public sector employment has helped equalize American society by offering workers of color stable, well-paid employment. The median wage earned by Black employees is significantly higher in the public sector than in private industries.

Privatizing public work like contact tracing contributes to racial and gender income disparities. Workers at federal call centers operated by Maximus, for example, are predominately women and people of color paid poverty wages as low as $10.80 an hour with unaffordable health care.

If #BlackLivesMatter—as many governors and mayors across the country have proclaimed in recent weeks—then contact tracing should be treated as what it is: a public good.

To catch up to other countries like Vietnam, the U.S. needs to get contact tracing right—and that means doing it with public workers.

 

 

 

 

HP unveils advanced security for remote workers — and shows how to disinfect your laptop

https://www.venture-med.com/hp-unveils-advanced-security-for-remote-workers-and-shows-how-to-disinfect-your-laptop/

HP has unveiled advanced security for businesses and their remote workforces and disclosed an extensive guide to disinfecting your laptop and other computer equipment.

The new offerings include HP Pro Security Edition, HP Proactive Security, and HP Sure Click Enterprise. These are aimed at the security threats that evolve and disrupt business every day.

With the recent surge of remote workers — due to work-from-home rules forced upon us by COVID-19 — HP said we must all be aware of the increased risks of working from home. Over 80% of home office routers have been found to be vulnerable to potential cyberattacks.

Emails also pose a significant risk to organizations, with over 90% of PC infections originating from attachments and 96% of security  breaches not discovered until months later. There are 5 billion new threats per month, based on HP’s estimates.

“Our HP Pro Security Edition takes Sure Sense and Sure Click and bundles [them] with our system,” said Andy Rhodes, global head of commercial PCs, in a press briefing. “Endpoints are still an enormous risk — 90% of infections originate with emails. Every user is at risk here.”

HP Pro Security for small businesses.

With public health concerns over COVID-19 spreading worldwide, HP wants customers to have the information they need to effectively clean HP devices and maintain a healthy work environment.

The Centers for Disease Control and Prevention (CDC) recommends cleaning surfaces, followed by disinfection, as a best practice for the prevention of COVID-19 and other viral respiratory illnesses in households and community settings.

In fact, HP has issued its own whitepaper for cleaning your devices.

“We get asked [about] this every day,” said Rhodes. “If you use the wrong disinfectant, you can actually damage the product.”

A CDC-recommended disinfectant that is also within HP’s cleaning guidelines is an alcohol solution consisting of 70% isopropyl alcohol and 30% water.

The steps below use the CDC-recommended alcohol solution to clean high-touch, external surfaces on HP products:

  1. Wear disposable gloves made of latex (or nitrile gloves if you are latex-sensitive) when cleaning and disinfecting surfaces.
  2. Turn off the device and disconnect AC power (printers should be unplugged from the outlet). Remove batteries from items like wireless keyboards. Never clean a product while it is powered on or plugged in.
  3. Disconnect any external devices.
  4. Moisten a microfiber cloth with a mixture of 70% isopropyl alcohol and 30% water. Do not use fibrous materials, such as paper towels or toilet paper. The cloth should be moist, but not dripping wet. (Isopropyl alcohol is sold in most stores, usually in a 70% isopropyl alcohol/30% water solution. It may also be marketed as rubbing alcohol.)
  5. Do not spray any liquids directly onto your device.
  6. Gently wipe the moistened cloth on the surfaces to be cleaned. Do not allow any moisture to drip into areas like keyboards, display panels, or USB ports located on the printer control panels, as moisture entering the inside of an electronic product can cause extensive damage to the product.
  7. Start with the display or printer control panel (if applicable) and end with any flexible cables, like power, keyboard, and USB cables.
  8. When cleaning a display screen or printer control panel, carefully wipe in one direction, moving from the top of the display to the bottom.
  9. Ensure surfaces have completely air-dried before turning the device on after cleaning. No moisture should be visible on the surfaces of the product before it is powered on.
  10. After disinfecting, copier/scanner glass should be cleaned again using an office glass cleaner sprayed onto a clean rag to remove streaking. Streaking on the copier/scanner glass from the CDC-recommended cleaning solution could cause copy quality defects.
  11. Gloves should be discarded after each cleaning. Clean hands immediately after gloves are removed.