Blog Tag: healthcare

DuPont to Acquire Spectrum Plastics Group

DuPont announced on May 2, 2023 its acquisition of Spectrum Plastics Group (“Spectrum”), a specialty plastics manufacturer, from the private equity firm AEA Investors for $1.75 billion.

Headquartered in Atlanta, GA, Spectrum was formed in 2017 via a merger of Pexco LLC and PPC Industries (including its Kelpac Medical subsidiary) as a portfolio company of the private equity firm Kohlberg & Company LLC. In 2018, AEA Investors’ Middle Market Private Equity team bought Spectrum from Kohlberg & Company, LLC. According to DuPont’s press release, Spectrum’s clients include 22 of the world’s 26 top medical device original equipment manufacturers (“OEM”). The industry served by these OEMs includes thriving medical sectors such as structural heart, electrophysiology, surgical robotics, and cardiovascular.

DuPont has a robust portfolio that already includes a medical device and biopharma consumables business and a healthcare packaging business, such as its Liveo silicone solutions business and Tyvek® Medical Packaging. Ed Breen, Executive Chairman and Chief Executive Officer of DuPont stated, when announcing the acquisition of Spectrum:

We have been focused on Spectrum for a long time and our team is extremely excited for this opportunity. Spectrum is a compelling strategic complement to our existing healthcare portfolio, which already includes businesses with best-in-class innovation, deep customer relationships and with strong growth and profitability. with this combination, we’ll be able to offer customers additional innovation and manufacturing capabilities with a broader and more integrated solution set.

According to DuPont’s press release, the deal is expected to close by Q3 2023 and DuPont plans to pay the purchase price from existing cash balances. DuPont expects the acquisition to bring a double-digit multiple on its 2023 forecast EBITDA and to be immediately accretive to its adjusted earnings per share.

 

 

FDA Publishes New Monkeypox and Medical Devices Web Page

The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes information on diagnostic testing, Laboratory Developed Tests (LDTs), and information for test developers. With more than 22,000 confirmed Monkeypox cases in the U.S., the new Monkeypox Medical Devices web comes as FDA takes significant actions to increase Monkeypox testing capacity nationwide following the Secretary of Health and Human Services’ August 9th announcement of public health emergency.

The FDA’s guidance issued for test developers under Policy for Monkeypox Tests to Address the Public Health Emergency describes, among other things, review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests. And, on the same day as the FDA guidance was issued, the FDA also issued the first EUA to a commercially available monkeypox test in the United States to Quest Diagnostics for its Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR device. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus,” said Jay G. Wohlgemuth, M.D., Senior Vice President, R&D, Medical and Chief Medical Officer, Quest Diagnostic.

Quest Diagnostics is not the only company that has been working on monkeypox diagnostic test kits. Earlier in June, Becton Dickinson announced partnership with CerTest Biotec to collaborate on molecular diagnostic test for monkeypox. Several other healthcare and pharmaceuticals companies have also been linked with this effort. This comes at a time when many of these companies are preparing for a drop in revenue from COVID-19 testing as the threat of COVID-19 reduces.

3M to Spin Off Health Care Business

The 3M Company announced on July 26th that it will spin off its health care business into a separate, publicly-traded company. The health care business will focus on wound care, oral care, healthcare IT, and biopharma filtration. The current health care business lines include bandages, skin adhesives, oral aligners, air purifiers, optical lenses, and the Bair Hugger™ surgical warming system that is currently the subject of nearly 6,000 lawsuits.

3M’s health care business generated $8.6 billion in 2021, which amounted to about one-quarter of the company’s total revenue. 3M confirmed that the non-healthcare main company will retain liability for all non-healthcare-related litigation, including the Combat Arms Earplugs litigation and PFAS litigation.

3M expects the move to increase the companies’ agility and focus to better position both companies for long term success and ability to tailor capital allocation strategies. In discussing the proposed move, 3M chairman and chief executive officer Mike Roman stated:

Disciplined portfolio management is a hallmark of our growth strategy. Our management team and board continually evaluate the strategic options that will best drive long term sustainable growth and value. The decision to spin off our Health Care business will result in two well-capitalized, world-class companies, well positioned to pursue their respective priorities.

This move comes off a string of similar moves from multi-national conglomerates, including General Electric Co.’s separation of its power, aviation, and healthcare businesses; Johnson & Johnson’s spin-off of its consumer health company; and United Technology’s spin-off and subsequent merger with Raytheon. The trend towards spinning off various businesses within these conglomerates comes as consensus grows among investors that businesses perform best when streamlined, according to Reuters.

Baxter Completes $10B+ Acquisition of Hillrom

On December 13, Baxter International Inc. (“Baxter”) announced the completion of one of the biggest medtech acquisitions of 2021, acquiring Hillrom (a global medical equipment maker headquartered in Chicago) for a purchase price of ~$10.5 billion.  The deal had originally been announced by Baxter in September 2021.

According to a statement on Baxter’s website, “Baxter’s acquisition of Hillrom has formed one of the world’s leading medical technology companies, centered around a shared vision to transform healthcare.”

Baxter’s product portfolio includes diagnostic, critical care, kidney care, nutrition, and surgical products used in hospitals, physician offices, and patient homes.  According to Baxter, the addition of Hillrom’s product lines, including legacy Welch Allyn products that were acquired by Hillrom in 2015, will help Baxter improve care outcomes and broaden access to care.  Hillrom’s products include the MacroView® Plus Otoscope, the Volara™ Oscillation & Lung Expansion Therapy System, the PST 500 Precision Surgical Table, and the Centrella® Smart+ Bed.

In a press release, Baxter’s chairman Jose E. Almeida stated:

The Baxter-Hillrom combination unlocks the next phase of our transformation, presenting a new wave of potential to drive greater impact for patients, clinicians, employees, shareholders and other communities we serve worldwide.  Integrating our complementary capabilities introduces additional opportunities for growth across our broad geographic footprint and also creates remarkable new possibilities for connectivity with leading-edge digital health innovation focused on enhancing care, lowering costs and increasing workflow efficiency.

According to the press release, Baxter expects the combination to result in ~$250 million of annual pre-tax cost synergies within 3 years.

FDA to Strengthen Cybersecurity Oversight

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket review process for medical devices. In particular, the report suggests including cybersecurity documentation as a criterion in the FDA’s Refuse-To-Accept (RTA) checklist, using presubmission meetings to address cybersecurity questions, and including cybersecurity as an element of the FDA’s Smart template.

The FDA has been ramping up its cybersecurity review lately to deal with increased cybersecurity concerns. For example, a ransomware attack caused an Indiana hospital to shut down its system. Other cyberattacks may have gone undetected.

Currently, the FDA reviews documentation that manufacturers submit regarding cybersecurity as part of the premarket submissions. The FDA uses this information to consider known cybersecurity risks and threats when reviewing submissions that deal with networked medical devices. The FDA may request additional information from applicants when submissions require clarification or when cybersecurity documentation is lacking. In view of these requests, the FDA regularly approves manufacturers on cybersecurity issues when sufficient documentation is provided.

For example, in one review of a glucose monitoring system, an FDA reviewer did not find “any information on how the manufacturer included cybersecurity in the device’s design,” according to the report. “The FDA reviewer explained that the device relied heavily on users to protect against cybersecurity threats by using antivirus software and enabling firewalls. The FDA reviewer requested that the manufacturer update its hazard analysis to address the missing information. The manufacturer did so, and FDA found the update to be acceptable.”

Because of examples like this, the report suggests using cybersecurity documentation as an element in the FDA’s RTA checklist. The RTA checklist is a screen against incomplete applications. Were cybersecurity part of these checklists, failure by a manufacturer to provide adequate cybersecurity documentation could prevent the FDA to accept the submission for substantive review.

The report also suggests that the FDA use presubmission meetings to address cybersecurity-related questions. These meetings serve as a way for manufacturers to ask the FDA specific questions, such as whether the submission satisfies the FDA’s standards. During these meetings, the FDA can include cybersecurity as part of the discussion, which may reduce the amount of time for the FDA review.

Finally, the report recommended that cybersecurity be a stand-alone element in the FDA’s Smart template. A dedicated section on cybersecurity could allow FDA reviewers to explain the results of their review regarding cybersecurity in a standard format.

The FDA has agreed with these recommendations and has begun taking steps to implement them, such as by including cybersecurity in the Smart template. The FDA also said that it “intends to update the RTA checklist and the accompanying guidance to specifically identify cybersecurity as an item in the checklist during the next update of these items.” The FDA is also currently considering new rules that may require submission of software as part of a premarket submission.

Envision Healthcare to be Acquired by KKR for $9.9B

Envision Healthcare to be Acquired by KKR for $9.9B

Envision Healthcare Corporation (“Envision”) recently announced an agreement to be acquired by KKR & Co. L.P. (“KKR”) for about $5.5 billion in cash. The transaction is valued at $9.9 billion, including the assumption or repayment of debt.  The transaction remains subject to regulatory and shareholder approvals, but is expected to close in the fourth quarter of 2018.

Envision, based on Nashville, TN, is a national physician staffing company and provider of physician services, including post-acute care and ambulatory surgery. KKR is a global private equity firm headquartered in New York, NY. The agreement to acquire Envision follows KKR’s 2017 acquisition of American Medical Response, an ambulance business subsidiary of Envision, for $2.4 billion.

It has been reported that other private equity firms including a consortium of Carlyle Group LP and TPG global competed for Envision.  According to a report by Bain & Co., the value of private equity deals in healthcare across the globe reached $42.6 billion in 2017, up 17% from $36.4 billion in 2016.

Regarding its acquisition of Envision, Jim Momtazee, Head of KKR’s Health Care investment team states:

Envision has a very strong reputation for delivering high-quality, patient-focused care through its network of 25,000 clinical professionals at thousands of hospitals, surgery centers and alternate sites of care across the country.  We are excited to partner with the outstanding team lead by Chris Holden to help build upon the strong foundation in place and accelerate Envision’s growth going forward.

 

Medical Device Connectivity Market Reported to Top $2.6 Billion by 2023

The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers.  The report states that the connectivity market for 2018 is expected to be about $940 million.  This equates to a compound annual growth rate (CAGR) from 2018 to 2023 of 23.2%.

According to news articles, the report states that “[t]he growth in this market is attributed to the increasing penetration of [electronic health records] and health information exchange systems in healthcare organizations, growing focus on care quality and patient safety, healthcare IT initiatives driving the integration of medical devices with hospital information systems, and the growing need to curtail healthcare costs through a connected healthcare environment.”

From 2018 to 2023, the medical device connectivity market CAGR is estimated to be 23.2%

The report further states the medical device connectivity services segment, as opposed to the device connectivity solutions segment, is anticipated to grow at the maximal CAGR during the “outlook period” from 2018 to 2023.  The report divides the technology sectors into wired, wireless, and hybrid technologies.  The wireless segment is projected to register the highest CAGR during the outlook period.

The report also breaks down the relevant markets into hospitals, home healthcare, ambulatory care settings, and imaging & diagnostic centers.  It finds in 2017 hospitals controlled the medical device connectivity market.  The report also finds that North America is expected to grow at the highest CAGR during the outlook period, followed by Europe.

The increase in the market is attributed in the report to “growing funding towards innovative projects in the medical market, [the] need to curtail the escalating healthcare costs in the USA, the presence of a big number of healthcare IT firms, rising investments in the healthcare sector by top market players, and increasing awareness about advanced technologies.”

The report is made available for purchase from several publishers, for example by Report Linker and Markets and Markets.

Healthcare Industry May Not Be Prepared For Internet of Things

A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT departments believe that current security systems for laptops and servers can also protect connected medical devices.

According to Xu Zou, ZingBox CEO, “Typically you will see 10 to 15 IoT devices per bed in a hospital.” He defines a healthcare IoT device as anything that is portable and connected to the Internet.

This has caused serious problems with medical and other organizations. For example, on May 12, 2017 a ransomware cryptoworm called WannaCry attacked on devices on every continent. An estimated 200,000 computers in 150 countries were infected. The attack included hospitals in England and Scotland and affected up to 70,000 devices, including MRI scanners, blood-storage refrigerators, and theater equipment. Some ambulances were diverted and some non-critical emergencies were turned away.

A more recent global attack occurred on June 27, 2017. Petya (also known as NotPetya), a ransomware cryptovirus, affected largely Ukrainian and Russian hospitals but also hit locations in France, Germany, Italy, Poland, the United Kingdom, and the United States.

In ransomware attacks, malware prevents a user from accessing certain computer records (e.g., patient records). These records are not released until a specified amount is paid to an anonymous recipient. Generally, these types of attacks rely on cryptocurrencies, such as BitCoin. Cryptocurrencies function like paper money, so the transaction is anonymous and difficult to trace.

“Health care has been late to respond to the need for protected information, and the information is worth more,” said Michael Ebert, a partner with KPMG who advised companies on cybersecurity. “It’s amazing how far behind we are, and we know we have to do something.”

Ransomware attacks not only show the vulnerability of hospitals (and healthcare companies generally), but they present a threat to human life. For example, experts have suggested that up to 500,000 children’s medical records are on sale and could be used to compromise the care given to a child.

Ransomware attacks are on the rise. A 2017 Verizon Data Breach analysis found that ransomware attacks rose from the 22nd most common type of malware attack to the 5th most common between 2014 and 2017. “[H]olding files for ransom is fast, low risk and easily monetizable,” wrote the authors. The report noted that 72% of all health care malware attacks in 2016 were ransomware.

Investments into IoT technology is also rising. So far it is at nearly $25 billion and is expected to rise dramatically. Accordingly, the spread of the technology can be expected to increase. Examples within the medical device community include blood pressure and heart rate monitors.

Most of those surveyed by ZingBox may be optimistic about the state of their security. However, the healthcare industry is likely to be more vulnerable in the future as the IoT becomes more ubiquitous.