中国国际医疗器械设计与制造技术展览会(Medtec China)2021

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1-3 September 2021 | SWEECC H2&H4

10 Big Developments in Medtech’s Fight Against COVID-19

2020-12-04

It has been a long road in the fight to effectively manage, prevent, and treat COVID-19. With the approval of the first vaccine for the virus now coming into play there seems to be some light at the end of the tunnel.

Throughout the journey, the medical device and diagnostics industry made major contributions in the fight against COVID-19. As it stands now more than 64 million cases worldwide with 1.5 million deaths, according to worldometers.info.

MD+DI has detailed 10 major developments in medtech’s battle against COVID-19.

1. Healthcare Goes Virtual with Telemedicine

Let’s face it, there was always going to be increased adoption in telemedicine. COVID-19 just sped the process up by five years or so. As the virus pushed society towards conducting business virtually, telehealth became the natural solution for patients and physicians. No more waiting in offices. Routine checkups could be done from a person’s living room.

Telehealth was indeed moving to the forefront and is predicted to have a strong presence beyond the pandemic.

The idea was a key topic of discussion during a panel at the Cleveland Clinic 2020 Innovation Summit. And Jason Mills, a medtech analyst at Canaccord Genuity, along with his colleagues also noted the shift to telehealth in a report published April 13th.

"The COVID-19 pandemic set off an accelerated shift to virtual communication in nearly every forum in which humans interact and, similarly, ... the medical device sector is also embracing the virtual world and will perhaps continue to do so long after the COVID crisis abates,” Mills and colleagues wrote.

2. Guardant Fulfills Civic Duty and Joins the Fight

Guardant Health is well-known for its liquid biopsy tests to detect cancer. However, the Redwood City, CA-based company made medtech headlines when it won emergency use authorization for a COVID-19 test in August.

Guardant said its COVID-19 test was used to help Delaware State University, a Historically Black College & University, reopen safely. The test was also used for Guardant Health employees and select partner organizations through the company’s CLIA-certified lab.

Guardant Health said jumping into the testing for the COVID-19 detection was its ‘civic duty’ and it wasn’t abandoning cancer testing by any means.

3. Tech Titans Unite

Google and Apple have been fierce rivals in the past, but the virus created a situation that called for the two to work together. In May, the tech rivals launched the Exposure Notification technology which can inform someone if they may have come in contact with a person that was diagnosed with COVID-19.

In a joint release, the duo said, “what we’ve built is not an app—rather public health agencies will incorporate the API into their apps that people install. Our technology is designed to make these apps work better. Each user gets to decide whether or not to opt-in to Exposure Notifications; the system does not collect or use locations from the device; and if a person is diagnosed with COVID-19, it is up to them whether or not to report that in the public health app. User adoption is key to success and we believe that these strong privacy protections are also the best way to encourage the use of these apps.”

4. Cardiovascular Devices Make an Impact

Abiomed was one of the first companies in the cardiovascular market to gain attention and emergency use authorization for technology to help with the treatment of COVID-19 symptoms.

The Danvers, MA-based company won the EUA in June for use of the Impella RP to unload the right ventricle of the heart and provide mechanical circulatory support.

In a June interview with MD+DI, Shon Chakrabarti, MD of Abiomed’s Medical Office Team said “what we’ve learned with COVID-19 … is that it’s not like a lot of the other respiratory viruses that have caused pandemics in the past. We definitely see a vascular effect. What we see is that it causes a prothrombotic environment in some patients. Some of these do get these pulmonary acute emboli and result in RV failure. There are a lot of really innovative physicians and interventional cardiologists that have used the right-sided device in these patients in the past.”

Abiomed’s EUA was significant because it put a spot light on the potential damage COVID-19 could have on the heart.

5. Digital Health Financings Soar

Attracting venture capital during the beginning of the global pandemic was an uphill battle for many med-device makers. But it wasn’t the case for digital health companies. Mercom Capital Group reported in June that the digital health funding in the first half of 2020 was 24% higher than the $5.1 billion the space raised in the first half of 2019, despite the pandemic disrupting the economy.

The spike in funding was caused by the increased adoption of digital health technologies and products during the COVID-19 outbreak, the Austin, TX-based firm noted.

The top-funded digital health categories in 1H 2020 were: telehealth with $1.9 billion, followed by analytics with $826 million, mHealth apps with $794 million, clinical decision support with $545 million, healthcare service booking with $326, and wearable sensors with $321 million.

6. Medtronic Shares Ventilator Designs

Early on in the pandemic, concerns grew over the shortage of ventilators in the healthcare market. It led to many companies from the automotive industry to develop the breathing devices. (Editor’s note: Even Fitbit won emergency use authorization for a ventilator.)

Medtronic answered the call and publicly shared design specifications for an older model of its ventilator technology, the Puritan Bennett 560 (PB 560). The move allowed companies across industries to evaluate options for rapid ventilator manufacturing to address the dire need for more ventilators for COVID-19 patients.

7. Abbott’s 5 Minute Test

Abbott Laboratories was already making headlines because of its COVID-19 tests.

However, the company’s assays became a major topic discussion when the BinaxNOW COVID-19 Ag Card, a $5, 15-minute COVID-19 Antigen test was introduced. The company received an EUA for the test in August.

The test was touted to be a game-changer because of its affordable price and guaranteed quick results.

8. FDA No Longer Regulates LDT’s

August was quite the turning point for regulation surrounding COVID-19 tests and laboratory-developed tests in general.

The Department of Health and Human Services posted that it determined FDA would not require premarket review of laboratory-developed tests absent notice-and-comment rulemaking, as opposed to through guidance documents, compliance manuals, website statements, or other informal issuances.

The posting goes on to say that “those seeking approval or clearance of, or an emergency use authorization for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions.”

At the time, the change in policy caused intense disagreement between both FDA Commissioner Stephen Hahn and HHS Secretary Alex Azar, according to a report from The Washington Post. The Post’s report also said the LDT policy came as a shock to may at FDA.

9. Standardizing Antibody Tests

Here’s the skinny with antibody tests. They differ among test manufacturers and currently cannot be analytically compared because they target different SARS-CoV-2 proteins. To solve this problem, Siemens Healthineers teamed up with the Centers for Disease Control and Prevention along with the Joint Research Centre of the European Commission to standardize the tests.

The collaboration calls for the Erlangen, Germany-based company to develop a process for standardizing SARS-CoV-2 assays by anchoring each protein to a neutralization antibody titer—a level of antibody present to block the virus from entering cells in laboratory experiments. The thresholds displayed in the standardized unit of measure for IgG—arising either from natural infection or vaccination — may likely contribute to a standardized interpretation of immunity through test results.

10. FDA Lays Out the Strategy

In late January, FDA created the strategy to combat COVID-19 that we see in place today. Part of that strategy was employing the use of the Emergency Use Authorization pathway to solutions for the virus. FDA said it would work with interagency partners product developers, international partners, and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate, and prevent outbreaks.

When FDA presented its strategy there were more than 4,000 cases of the virus that have been confirmed in China. More than 100 people had succumbed to the disease – however, none of those deaths were in the U.S. There were five reported cases in the U.S.