Blog Tag: Global Medical Device Industry
The medical device and related markets have shown some growth recently. For example, IHI, an iShares U.S. Medical Devices ETF, has a total return of about 24% year-to-date in 2018. In the same time period, the S&P 500 has a return of about 8%. The IHI fund has an average annual return in the last ten years of about 14% compared to about 10.7% for the S&P 500. According to MarketWatch, the IHI fund invests in “medical-products companies that deliver the tubes, pumps and tools that are necessary to make medical facilities function. . . . While some of the products offered by these companies are indeed high-tech, such as artificial heart valves, many are less glamorous, such as catheters and blood-pressure cuffs. But despite their flash, these items are staples, and medical offices and hospitals nationwide remain big revenue sources for these companies.”
MarketWatch further reports that ETFs related to healthcare in general have “more than tripled the returns of the S&P 500 this year.” For example, the largest healthcare ETF by funds, XLV, is reportedly up 10% this year, and the IBB fund is up about 330% over the last ten years. Other healthcare-related funds reported to be outperforming the S&P 500 year-to-date in 2018 include the following:
- Janus Henderson Obesity ETF “SLIM,” up 20%;
- iShares U.S. Healthcare Providers ETF “IHF,” up 22%,
- Invesco DWA Healthcare Momentum ETF “PTH,” up 23%;
- the Ark Genomic Revolution Multi-Sector ETF “ARKG,” up 23%;
- the SPDR S&P Health Care Equipment ETF “XHE,” up 27%; and
- the Invesco S&P SmallCap Health Care ETF “PSCH,” up 40%.
There has been some activity and forecasts in the medical device market recently reported. Some forecasts include the market for medical device connectivity projected to reach about $2.6 billion by the year 2023. The global market for “IoT” (internet of things) medical devices is projected to grow at a compound annualized growth rate (CAGR) of about 25% from 2018 to 2023. For the same period, the market for anesthesia-related devices is expected to have a CAGR of about 6.4%. The global market for retinal surgery devices is reported as “likely to exceed $3 Billion by 2025, almost double from its current level in 2017.” The global market for brachytherapy devices is reportedly predicted to rise at 4.2% CAGR from 2017 to 2022.
Some examples of recent medtech funding and M&A activity have included: CytoSorbents, a critical-care immunotherapy company that specializes in blood purification, received a research award of up to $3 million from the NIH. Irvine-based Endologix, provider of solutions for aortic disorders, reportedly recently took out a $210.5 million convertible loan facility. Urotronic, developer of a drug-coated balloon catheter for treating urethral strictures in men, reportedly raised $20 million in an equity offering involving 7 investors. 410 Medical Inc. a Durham, North Carolina-based company focused on technologies for resuscitation of critically ill patients, reportedly recently raised $3.1 million in financing.
As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2 billion in 2016, and is projected to continue to grow. The medical device industry is outsourcing not only the manufacturing of medical devices, but also associated services, such as regulatory consulting and contract manufacturing, to medical device service providers. Medical device manufacturers and outsourced medical device service providers should be conscious of the regulatory and legal ramifications of the delocalization associated with the outsourcing that is increasingly common in today’s global market.
While outsourcing has traditionally been linked to manufacturing, outsourcing of services has become a major growth engine in the medical device industry. Outsourced services include regulatory consulting, product design and development, testing and sterilization, implementation, upgrades, maintenance, and manufacturing contracts. Regulatory consulting, which in 2015 already commanded over 50% of the outsourcing market for services, is particularly expected to grow. Regulatory consulting includes services directed to compliance with national agencies that approve and continually monitor the safety of medical devices, including the F.D.A. in the United States and the E.F.S.A. in Europe. In addition, contract manufacturing is reported to be the fasted growing service in the medical device industry and is projected to grow at a compound annual growth rate of over 11.5% through 2025.
There are several benefits associated with medical device outsourcing. According to an MDDI article, outsourcing can help original equipment manufacturers (OEMs) accelerate time to market for a new product, and speed up return on investment. Furthermore, the article states outsourcing can provide specialized knowledge, expertise, and facilities without the significant resources required to acquire such expertise in house. Moreover, outsourcing can leverage the pre-existing large supply chain of the contractor.
However, outsourcing also carries potential risks. The issues associated with outsourcing so many aspects of services uniquely associated with the medical device industry may not be as well known or well understood as the issues presented by outsourcing manufacturing. According to another MDDI article, these issues may include an increased risk of civil lawsuits from consumers of medical devices. This is especially true as medical devices become increasingly digital, and cybersecurity vulnerabilities are found. The medical device industry may also face increased regulatory scrutiny from national agencies as more regulatory compliance is outsourced to consulting services. Consequently, the medical device industry and medical device legal community will increasingly face new challenges from a world in which more and more industry services are outsourced.
Since its passage as part of the Affordable Care Act in 2010, the medical device tax has been hotly debated. The 2.3% excise levied on total revenues may effectively preclude new entrants while hindering the growth of established companies. While industries have turned to outsourcing for a number of years as a way to cut costs, the medical device industry may increasingly consider outsourcing in the coming years as a means to offset the effects of this tax. While outsourcing may help U.S. medical device companies, it may adversely affect Americans currently working in this sector.