Hot Areas for MedTech After the Pandemic

As the COVID-19 pandemic has swept the globe, the medtech industry has risen to the challenge, developing innovative devices, treatments, tests, and personal protective equipment (PPE). The pandemic’s impact on hospitals and healthcare systems has been swift and dramatic. Elective surgeries and procedures have been cancelled, telemedicine has taken off, and field hospitals have been built in parks to treat infected patients.

The medtech industry has developed new diagnostic tests to detect the virus and its antibodies. The ability to rapidly and accurately test patients is critical to contain the virus now and in the future.

Similarly, the shortage of medical equipment, particularly life-saving ventilators, and the push to find a COVID-19 vaccine, have spawned new innovations to help combat the virus and prevent further spread. This column discusses hot areas of medtech innovation as the post-coronavirus environment takes shape.

Diagnostics Presents Multi-Billion-Dollar Opportunities
At the height of the pandemic, many U.S. cities had low COVID-19 test supplies, as manufacturing and production tried to keep up with high demand. After several months, there has been some testing relief due to an unprecedented public-private sector collaboration.

To address the COVID-19 testing shortage, analysts predict billions of dollars in sales for the rest of the year. COVID-19 tests have already become more widely available as more testing is conducted in commercial, private, and academic labs. Analysts expect the largest diagnostics companies to produce up to 30 million virus detection tests per month to meet increasing demand. With the addition of serological tests for COVID-19 antibodies, which can detect virus exposure and recovery, there soon could be 50 million COVID-19-related tests per month.

There will be several promising areas of diagnostic testing innovation in the future. Some proposed long-term testing solutions include the creation of saliva assays, DIY home kits, and mass testing centers.

For example, companies are developing visual lateral flow strip test kits for COVID-19, which would work like pregnancy tests. This technology could test numerous samples without specialized instruments or reagents, producing results in under an hour. The earliest versions of these tests still need to be run in a centralized lab, but future versions could be done in the field, at home, or at the point of care. Other companies are focused on diagnostic tests to assist with contact tracing and to assess recovery rates.

While rapid detection tests are still awaiting FDA approval, these types of diagnostic innovations will help experts evaluate real-time movements of viruses and infectious diseases before they become a global pandemic.

Diagnostics Needs Strategic Patents
The pandemic has brought renewed focus on diagnostic patentability. For medtech innovators looking to develop COVID-19 diagnostic tools, obtaining patent protection is important but may be challenging due to recent U.S. Supreme Court decisions.

In a landmark 2012 decision, the Court ruled the diagnostic method patents at issue were based on a law of nature and, thus, not eligible for patent protection. The Court invalidated two Mayo Clinic patents.

Two years later, the Court announced a two-part test for determining whether an innovation has an inventive concept that is beyond unpatentable laws of nature, natural phenomenon, or abstract ideas, and therefore eligible for patenting.

These Supreme Court decisions impact the patentability of COVID-19 tests based on the correlation between an antibody’s presence and a disease. Creative patent strategies are necessary to secure patent protection for such diagnostic tools.

Some medtech innovators, especially early-stage companies, may be reluctant to invest in diagnostic tests. One potential solution is for Congress to enact legislation confirming the eligibility of diagnostic tests for patent protection.

Next-Generation Ventilators and Breathing Assist Devices
Throughout the pandemic, ventilators have saved the lives of critically ill patients. Due to supply shortages, doctors were forced to make life-and-death decisions regarding patients with severe respiratory failure.

As COVID-19 cases skyrocketed in America, a widespread shortage of medical supplies reached a critical point. The federal government tapped its medical supplies reserve at the U.S. Strategic National Stockpile, which contains about $8 billion worth of medical equipment.

In a post-COVID-19 world, the nation’s depleted stockpile will need replenishing. This will generate new opportunities for medtech companies to develop and manufacture various medical supplies such as vaccines, PPE, ventilators, and more.

In addition to simply replenishing warehouse inventory, medtech companies can develop innovations that improve the performance of present-day equipment while potentially lowering costs. For example:

• New ventilators and breathing assist devices are being designed for partially-recovered patients and those not in ICU. Often called “bridge” ventilators, such devices could free up more powerful and expensive intensive care ventilators for critically ill patients.
• Many consumer product, automotive, and industrial firms manufactured ventilators to address the shortage, and also designed and built new ventilators that can be produced quickly, cost-effectively, and at volume.
• An MIT team revived a 10-year-old emergency ventilator project known as E-Vent. The open-source ventilator design is affordable and easily replicated, enabling manufacturers and companies worldwide to recreate the device.

Finding Freedom to Operate in a Crowded Patent Landscape
In responding to the pandemic, scientists have willingly shared knowledge of potential treatments, coordinated clinical trials, and published research findings quickly. In this new climate of cooperation, it is easy to forget that commercial medtech companies typically keep R&D private and protect their innovations through patents. During the coming wave of invention in the pharmaceutical, medical diagnostics, and equipment sectors, it will be important for companies to find “white space” as part of their patent strategy.

The amount of “white space” measures a technology area’s capacity for new patent applications. If the patent landscape is relatively clear, there is much white space to stake new patent claims.

Before launching a new product, a company should undertake a “freedom to operate” analysis to avoid infringing third party-owned patents. After conducting a thorough search of patent and scientific literature databases and identifying third-party patents, a medtech company should maximize its patent presence within that particular technology area. It can accomplish this by identifying potential patent design-around opportunities that a competitor might use and blocking these opportunities by seeking new patents or modifying its current patent applications.

Combination products and therapies are another means of exploring patent white space and anticipating industry developments. Examples of combination products for COVID-19 include improved drug delivery systems involving auto-injectors, syringes, inhalers, as well as nasal, subcutaneous, and oral vaccines.

Telemedicine Takes Off
Telemedicine has become more popular because many patients now don’t want to risk infection by visiting a doctor’s office. Telemedicine uses electronic technologies including video conferencing, smartphones, and email to examine and exchange medical information about a patient. Telemedicine is faster, often delivers better quality, and is almost always less expensive than traditional office-based medical delivery.

The explosion of telemedicine appointments with doctors for COVID-19 diagnosis, annual exams, and ongoing care has made telemedicine one of the fastest-growing areas in healthcare today. But the growth of telemedicine faces challenges including technology issues for doctors and patients; lack of standards and regulations; a crowded patent landscape; cybersecurity; and increased state and federal scrutiny.

Continued growth of telemedicine will be driven by many factors including surging adoption of telemedicine, the growing geriatric population, increasing chronic diseases, government initiatives, and a doctor shortage. The widespread acceptance of telemedicine during COVID-19 will have long-lasting impacts on the healthcare system.

Imaging Comes Into Focus
Imaging has become an important way to diagnose COVID-19, even when lab test results are negative. Medical scans of COVID-19 patients can reveal how the virus attacks the lungs.

A CT or CAT scan uses a combination of X-rays and computers to create pictures of organs, bones, and other tissues. Chest and lung scans have become an effective tool for detecting, quantifying, and tracking COVID-19. The coronavirus affects the lungs in such a specific way that doctors can often detect the virus simply by viewing CT scans.

Some studies have found that chest CT scans outperformed lab testing in diagnosing COVID-19. Thus, some researchers believe that CT scans should be used as the primary screening tool for COVID-19. But this could present its own challenges.

Given their high cost, hospitals have limited numbers of CT machines. Also, the large size of the machines means scanners are not portable. Also, cleaning and sterilization of the CT tube between patients can lead to significant downtime for the CT machine. Mobile X-ray machines address these concerns, but X-ray images are not as detailed as CT scans.

There is a need for cost-effective CT machines that can be deployed in hospitals globally. In addition, new imaging modalities that are portable, cost-effective, and easily sanitized between patients could become critical equipment to help diagnose and treat COVID-19 and future diseases.

Pandemic Leads to New Medtech Innovations
The medtech industry has been at the heart of this pandemic. Innovations in diagnostic testing, medical equipment, telemedicine, and imaging are powerful tools to help fight COVID-19 and prevent future outbreaks. As we enter a post-COVID-19 environment, medtech companies will develop new technologies to help improve treatment, identify outbreak hotspots, prevent infections, and vaccinate the world against the virus and future pathogens. 

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David J. Dykeman is a registered patent attorney with over 23 years of experience in patent and intellectual property law, and co-chair of Greenberg Traurig’s Global Life Sciences & Medical Technology Group. He can be reached at [email protected] or at 617-310-6009.