- The recent trade war between the United States and China has resulted in increased tariffs on the med tech industry and adjacent industries. Many big medtech companies have manufacturing facilities in China and/or source products or components from the country. “The U.S. medical device industry initially faced nearly $1 billion in tariffs after the Trump administration slapped China with its first round of tariffs in July 2018, trade group Advamed reported at the time.” Now, however, the industry has seen some relief, as some medical devices have been exempted from tariffs, such as dental, radiotherapy, and surgical devices.
- The US Environmental Protection Agency (EPA) began cracking down on ethylene oxide (EO), a product used to sterilize medical devices, in 2019. It began when the agency “changed the sterilant’s classification from “possibly carcinogenic” to a determination that long-term exposure could cause elevated risks for certain cancers, including non-Hodgkins lymphoma, myeloma, lymphocytic leukemia and breast cancer.” The EPA is currently in the process of amending the 2003 Miscellaneous Organic Chemical Manufacturing National Emission Standards for Hazardous Air Pollutants (NESHAP). Ethylene oxide is currently used to sterilize 56% of devices in the medtech industry, so new regulations on the substance could have dramatic effects on the industry.
- Despite these regulatory shifts, industry experts believe that regulation has decreased quite dramatically in recent years, particularly in the years of the Trump administration. A July 2019 report found that the FDA’s enforcement of regulations was down by -32.6%. The report found that the agency issued one third less warning letters than during the Obama administration, and two-thirds fewer warning letters for medical devices specifically.
- At the same time, the FDA’s behavior may be shifting back towards greater enforcement of regulations. The agency has been under scrutiny in the past year, particularly for its medical device approval process. As a result, “FDA has announced plans to reorganize its Center for Devices and Radiological Health, reforming the way 510(k) clearances are handled, and increase scrutiny of materials in medical devices.”
- One trend continuing in the medtech industry is a high rate of mergers and acquisitions (M&A) as companies strive to remain competitive by acquiring new technologies and absorbing competition. In 2019, for example, 3M bought wound care company Acelity for $6.7 billion; Boston Scientific bought BTG and Vertiflex; and Johnson & Johnson bought Auris Health for $3.4 billion.
- The use of augmented reality and virtual reality (AR and VR) is another trend in the medtech space. “Doctors, students and surgeons can train and see 3D renditions that look exactly like the real thing, where 2D imaging has always lacked that functionality.” This technology is projected to reduce errors and improve precision, particularly important for sensitive parts of the body like the brain and heart. AR and VR also have applications for physical therapy, as they have shown to be effective for retraining the muscles of the body, such as after an accident or paralysis.
- Another trend is wearable smart technology. The use of this technology has increased rapidly, and patients can now access technologies like smart contact lenses that measure glucose levels or wearable ECG devices that detect atrial fibrillation. This trend goes hand-in-hand with artificial intelligence. “The infusion of artificial intelligence into wearable health devices was first approved by the FDA in April, a smart device is able to measure vital signs like pulse and oxygen with machine learning analyzing any abnormalities.”
- Blockchain is another technology which potentially has applications for the medtech industry. Data security is a major concern when it comes to medtech and medical devices, as protecting patient privacy is a top priority. “Blockchain’s anti-tampering functionalities could potentially help reduce data hacks and tampering if implemented, however blockchain can also increase interoperability of all patient healthcare records by making them visible (yet secure) across every hospital network.”
- In addition, 3D bioprinting is a trending technology in the medtech space. Bioprinting uses live tissues and living cells to create organ components and other anatomical features that can be used inside the human body. “Volumetric bioprinting can print off functional and personalized 3D parts in seconds using beams of lasers, and while printing off functioning whole organs for transplant is still in research, printing off heart valves and ventricles has seen success. 3D bioprinting doesn’t just exist for organ transplants, education and drug testing have all flocked to 3D bioprinting.”