According to the World Health Organization (WHO), as of June 10, the SARS-CoV-2 virus (a.k.a. COVID-19 or simply coronavirus) has infected over 7 million people across the globe. While the global situation has begun to show signs of improving, COVID-19 continues to spread. Countries around the world have imposed travel restrictions to stem the virus’ transmission.
According to the Centers for Disease Control and Prevention (CDC), as of May 12 the number of U.S. COVID-19 cases is almost 2 million. The U.S. has imposed severe restrictions—"stay at home" orders, prohibiting public gatherings, and temprarily shutting down all non-essential businesses. The aim is to “flatten the curve” of rapid growth in COVID-19 cases that threatens to grossly overburden the nation’s healthcare system.
Medical device companies play an integral role in responding to the COVID-19 outbreak. Rapid development of COVID-19 diagnostic tests ensures cases are quickly identified and quarantined. (Diagnostic tests currently approved under the FDA's emergency use authorization can be found here.) Face masks provide healthcare workers with extra protection from contracting the virus as they tend to the growing number of COVID-19 patients. Ventilators and other critical care equipment keep COVID-19 patients alive as they battle the virus. Telemedicine programs allow high-risk patients to consult with a doctor without leaving their homes, and allow lower risk infected patients to remain in their homes as they recover.
Here are the ways medtech’s leaders (The MPO Top 30) are responding to the outbreak.
The Medtronic Foundation committed about $1.2 million to global coronavirus relief efforts in early February. The donations were made to:
- International Federation of Red Cross and Red Crescent Societies, which is deploying medical teams to areas hit hardest by the outbreak
- The CDC Foundation to meet quickly emerging needs the CDC identifies to respond to the public health threat
- Project HOPE, which mobilizes and delivers personal protective equipment to Chinese hospitals
The company also donated ventilators, respiratory filters, pulse oximeters, as well as sensors and centrifugal blood pump systems for cardiopulmonary bypass surgery to Wuhan Huoshenshan Hospital.
On March 18, Medtronic began doubling its capacity to manufacture PB 980 and PB 840 ventilators by doubling the number of manufacturing shifts in its Galway, Ireland facility.
The Medtronic Foundation made an additional $10 million donation to global COVID-19 relief efforts on March 25. The money will help train, supervise, and distribute personal protective equipment and critical supplies to frontline health workers. It will also support health workforce preparedness efforts and offer vulnerable populations health, economic, and food assistance.
On March 27, Medtronic's Medtronic Care Management Services (MCMS) business launched two new solutions to monitor COVID-19. The Respiratory Infectious Disease Health Check helps patients at the highest risk of complications or mortality track respiratory infectious disease symptoms and body temperature through daily health checks. It presents symptom questions based on patient responses, and provides patient education to support self-care. The COVID-19 Virtual Care Evaluation and Monitoring solution has a virtual assistant that evaluates patients through a CDC guideline-based survey for symptoms. The the users's symptoms warrant it, they are connected to the MCMS nurse command center for further assessment.
Medtronic made the design specifications for its Puritan Bennett 560 (PB 560) ventilator available to the public on March 30 in order to increase global ventilator production. PB 560's product and service manuals, design requirement documents, manufacturing documents, and schematics are available at Medtronic.com/openventilator. Software code and other information will follow.
The company announced a $1 million donation of insulin pump sensors, infusion sets, and reservoirs to Insulin for Life USA on May 1 to support diabetic patients experiencing financial hardship due to COVID-19.
Johnson & Johnson
On Feb 11, Johnson & Johnson’s Janssen pharmaceutical business started collaborating with the U.S. Department of Health & Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to expedite its investigational coronavirus vaccine program.
On March 13, Janssen began collaborating with the Beth Israel Deaconess Medical Center to develop a preventive vaccine for COVID-19. Preclinical testing has begun for multiple vaccine prospects. J&J expects to identify a candidate for clinical trials by the end of March. Both vaccine programs leverage Janssen technologies that provide the ability for rapid upscale production of the optimal vaccine candidate.
On March 30, the company chose a lead COVID-19 vaccine and expects to initiate a Phase 1 clinical study by September at the latest. J&J anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021. Normally, vaccine development spans 5 to 7 years before a candidate is considered for approval.
J&J is also establishing new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries.
On April 15, CEO Alex Gorsky was named to the White House task force designated by President Trump to provide recommendations on how best to safely reopen the U.S. economy in the wake of the pandemic.
The company began work with Emergent BioSolutions on April 23 to produce over a billion doses of a COVID-19 vaccine candidate. J&J is preparing for clinical vaccine production at its Leiden, Netherlands facility and hopes to begin a Phase 1 clinical trial on humans in September.
On April 29, J&J's Janssen unit began collaborating with Catalent to accelerate manufacturing capacity and prepare for large-scale production of J&J's lead vaccine candidate.
J&J's Janssen unit announced it had moved the starts of its Phase 1/2a clinical trial evaluating its SARS-CoV-2 vaccine candidate to the second half of July from September. The study will tests its safety and immunogenicity in 1,045 healthy adult volunteers in the U.S. and Belgium. The company is currently in talks with the National Institutes of Allergy and Infectious diseases too accelerate the start of the Phase 3 study pending the outcomes of Phase 1s and regulatory signoff.
President and CEO Kieran Murphy announced March 19 that GE Healthcare has increased manufacturing capacity and output of equipment for CT scanners, ultrasound devices, mobile X-ray systems, patient monitors, and ventilators by adding manufacturing lines and hiring additional manufacturing employees.
On March 24, GE Healthcare began working with Ford Motor Company to scale ventilator production. Ford will provide technical and production expertise with the goal of manufacturing a simplified ventilator design. GE Healthcare also updated its website, adding information about using its anesthesia devices for patients needing machanical ventilation.
On April 14, the company brought its Mural Virtual Care Solution, which gives hospitals a broad view of their ventilated patient population and helps identify those at risk for deterioration, to the Microsoft Azure platform. Mural will integrate near real-time data from ventilators, patients monitoring systems, electronic medical records, and labs, allowing clinicians to monitor several COVID-19 patients at once while reducing exposure.
On April 16 the Department of Health and Human Services began a $336 million contract with GE and Ford to build 50,000 ventilators by July 13.
Abbott gained emergency use authorization for its RealTime SARS-CoV-2 molecular test on March 18. The test is run on the company's m2000 RealTime System, which can run up to 470 tests in 24 hours.
Abbott immediately began shipping 150,000 tests to existing U.S. customers after receiving FDA authorization. The company hopes to soon have the ability to provide up to a million tests per week.
On March 28, Abbott gained emergency use authorization for a molecular point-of-care test that can detect COVID-19 in five minutes and provide negative results in 13 minutes. It runs on the firm's ID NOW platform, which weighs 6.6 pounds and is about the size of a small toaster. The test can be conducted in a wide variety of healthcare settings like physicians' offices, urgent care clinics, and hospital ERs. ID NOW COVID-19 tests became available in urgent care settings the week of March 30.
Abbott's FreeStyle Libre 14-day continuous glucose monitor was cleared for use in hospitals on April 8, minimizing diabetes patients to exposure. According to the CDC, over half of all diabetes patients diagnosed with COVID-19 are hospitalized.
The company launched a serology blood test to detect the antibody IgG that idenitifies if a person has had COVID-19. It will shed light on how long antibodies stay in the boy and if they provide immunity, potentially supporting treatment and vaccine development. Abbott hopes to ship 4 million tests in April, eventually ramping up to 20 million tests in June. The company will also expand its laboratory antibody testing to spot the IgM antibody in the near future.
On April 15, CEO Robert Ford was named to the White House task force designated by President Trump to provide recommendations on how best to safely reopen the U.S. economy in the wake of the pandemic.
Abbott gained emergency use authorization on May 11 for its SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. The company plans to ship almost 30 million antiboy tests in May.
The firm's COVID-19 molecular test for the new Alinity m molecular laboratory instrument received emergency authorization on May 12. Alinity m can run up to 1,080 tests in 24 hours.
The FDA warned on May 15 that early data (15 adverse event reports) suggested Abbott's ID NOW point-of-care test to diagnose COVID-19 may return false negatives. Abbott immediately underwent a multi-site clinical study, and reported interim results a week later that determined test performance is ≥94.7 percent in positive agreement (sensitivity) and ≥98.6 percent negative agreement (specificity) when compared to two different lab-based PCR reference methods.
In January, the Philips Foundation donated a range of diagnostic imaging, patient monitoring, and respiratory therapy equipment and supplies to Wuhan's Thunder God Mountain Hospital. The Foundation is also working with Philips' teams in Kenya, South Sudan, and Italy to support their deeply impacted healthcare systems.
The company has ramped up production and roll-out of certain diagnostic imaging systems, patient monitors, and ventilators—particularly vital signs monitors, portable ventilators, and consumables for non-invasive and invasive ventilation. Philips will hire additional manufacturing employees, add manufacturing lines and increase the number of shifts, and engage with third party contract manufacturers to increase production.
Philips also provides a telehealth solution to process high volume coronavirus-related healthcare requests via online screening, follow-up questionnaires and monitoring, and external call center collaborations.
The company began partnering with contract manufacturers Flex and Jabil on April 13 to further expand its Trilogy EV300 and Respironics V60 hospital ventilator assembly lines. Philips hopes to manufacture 4,000 units per week by the third quarter of this year. The same day, Philips released its Respironics E30 ventilator for emergency use to help free up ICUs. The company expects to produce 15,000 units per week in April.
Philips’ ultrasound solutions—including the EPIQ series, Affiniti series, Lumify, CX50, and Sparq diagnostic ultrasound systems, as well as its QLAB Advanced Quantification Software—gained 510(k) clearance to manage COVID-19-related lung and cardiac complications on May 13. Handheld and portable ultrasound solutions have become valuable tools to treat COVID-19 patients due to their imaging capabilities, portability, and ease of disinfection.
The firm's BX100 5-day, single-use wearable biosensor gained 510(k) clearance and CE mark to monitor COVID-19 patients on May 26. It supports surveillance of higher acuity patients moving from ICUs to lower acuity hospital areas.
Philips’ IntelliVue Patient Monitors MX750/MX850 and its IntelliVue Active Displays AD75/AD85 earned an EUA to monitor COVID-19 patients on June 2. They support infection control protocols and remotely provide patient information critical care for hospitalized COVID-19 patients.
Becton Dickinson (BD)
CerTest BioTec’s ViaSure SARS-CoV-2 Real Time PCR Detection Kit was granted CE mark for use with BD’s Max system on March 10. The system performs nucleic acid extraction and real-time PCR, and provides results for up to 24 samples in less than three hours. Europe has a large installed base of BD Max systems, according to BD’s VP of molecular diagnostics and women’s health Nikos Pavlidis.
On March 31, BD and N.C.-based clinical diagnostics firm BioMedomics released a point-of-care test that can spot antibodies in blood to confirm current or past exposure in as little as 15 minutes.
BD and biotech firm BioGX were granted FDA emergency use authorization for a SARS-CoV-2 diagnostic test that runs on the BD Max molecular diagnostic platform on April 2. The system can process 24 samples simultaneously with results in under three hours. The tests are expected to add capacity for 50,000 tests per week nationwide.
BD gained emergency authorization for an additional molecular COVID-19 diagnostic test that can provide results in two to three hours on April 13.
On April 15, CEO Mike Kaufmann was named to the White House task force designated by President Trump to provide recommendations on how best to safely reopen the U.S. economy in the wake of the pandemic.
On March 11, Siemens Healthineers-backed teleradiology and telemedicine firm USARad launched a screening program that connects radiologists to healthcare workers on the front lines of the outbreak. The company will also provide a network of chest CT-trained imaging experts, along with pulmonologists and infectious disease specialists. Studies have shown the imaging modality plays a key role in identifying the virus, including the ability to spot lung abnormalities.
On April 22, the company announced development of a lab-based test to detect IgM and IgG antibodies for the SARS-CoV-2 virus. Available on the Atellica Solution immunoassay analyzer, it can run up to 440 tests per hour with results in 14 minutes. Siemens Healthineers expects the test to be available by late May.
The firm's lab-based SARS-CoV-2 total antibody test recieved EUA on June 1. According to the company, the test demonstrated 100 percent sensitivity and 99.8 percent specificity. The test, which is also CE marked, began shipping the week prior.
On April 3 Stryker released a low-cost, limited-release emergency response bed to help care providers with efficient care. It includes a six-inch thick foam surface. 30-degree head of bed angle, low height, and an attached IV pole. The company aims to produce 10,000 beds a week.
The company has boosted production for high demand products like the the PrisMax and Prismaflex blood purification systems, Mini-Bag Plus drug delivery system, and Spectrum IQ infusion system. In response to increase demand, Baxter is creating 2,000 new permanent and temporary employment opportunities.
The Baxter International Foundation is also donating over $2 million to humanitarian relief organizations on the front line of the pandemic globally.
The company's Oxiris filter set earned FDA emergency use authorization to treat COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure on April 22. Blood purification therapy can reduce pro-inflammatroy cytokine levels.
Beckman Coulter (a Danaher business)
On March 31, the company said it was developing assays to identify igM and igG antibodies to the SARS-CoV-2 virus for its Access 2 and Dxl series systems. Beckman Coulter will then seek FDA emergency use authorization.
Cepheid (a Danaher business)
Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2 rapid molecular diagnostic test on March 21. The test has a dection time of about 45 minutes and patients can be tested at the point of care. The test began shipping shortly after gaining FDA authorization.
Cepheid began developing an Xpert Xpress combination test to detect SARS-CoV-2, Flu A and B, and RSV on June 9.
Integrated DNA Technologies (IDT, a Danaher business)
On March 16 IDT announced success in large-scale manufacturing of a primer and probe kit, which assists in DNA analysis of patient samples for COVID-19 testing. IDT’s reagents for SARS-CoV-2 virus diagnostic testing were authorized by the FDA on March 3. As of March 9, IDT had shipped the CDC kits sufficient to enable over one million diagnostic tests. During the week of March 9, IDT manufactured kits for 2.5 million tests, and expects to manufacture for 5 million tests per week starting March 16.
The company is donating personal protective equipment to local hosptals and non-profit organizations. Zimmer Biomet is also partnering with an industry coalition and using 3D printing technology to make critical ventilator and face shield components. The company's philanthropic foundation is also donating to multiple non-profits supporting COVID-19 initiatives.
Zimmer biomet president and CEO Bryan Hanson is also forgoing 100 percent of his salary amid the crisis.
The FDA granted emergency use authorization on April 13 to the company's Perfusor Space Syringe Infusion Pump, Infusomat Space Volumetric Infusion Pump, and Outlook ES Pump systems for tracheal delivery of continuous nebulized medications into a nebulizer to treat COVID-19 patients.
The company’s N95 face masks (so named because they filter 95 percent of micron-sized particles in testing) have been in incredibly high demand due to the outbreak. 3M increased production, stating that its Aberdeen, S.D. facility has the capability and experience to adapt production to demand due to previous significant demand from the SARS, H1N1, and Ebola outbreaks. The plant has increased from a five-day to a seven-day production schedule. The FDA has approved sterilization systems from Advanced Sterilization Products and STERIS to safely clean, reuse, and extend the life of N95 respirators.
The U.S. government has also contracted with 3M, along with other manufacturers, for production of 35 million more face masks per month.
On March 20, 3M announced it had doubled global output of N95 masks. The company has also not increased the prices of the N95 masks. Over the next 12 months, 3M plans to increase investments to expand global capacity another 30 percent. Production of hand sanitizers, disinfectants, and filtration solutions has also been maximized.
3M began collaborating with Ford Motor Company on March 24 to increase production of powered air purifying respirators, which are waist-mounted, battery-powered blowers that sends filtered air into a hood that helps provide respiratory protection. 3M has doubled global output of N95 respirators to a rate of over 1.1 billion a year.
To help people avoid inflated N95 mask prices, 3M published current single-case list prices for the most common N95 respirators sold in the U.S. on its website.
On April 6, 3M and the Trump Administration announced a plan to import 166.5 million N95 respirators from 3M's Chinese manufacturing facility over the next three months.
The company filed a lawsuit against N.J.-based Performance Supply LLC on April 12. The defendant falsely claimed business affiliation with 3M, and offered to sell $45 million in N95 respirators to NYC officials at prices five to six times over 3M's list price. The complaint aims to cease Performance Supply's illegal activities and requests damages that 3M will donate to COVID-19 nonprofits.
3M began a partnership with Cummins to boost production of high efficiency particulate filters for use in 3M's powered air purifying respirators (PAPRs) on April 14. The collaboration could more than double current production of filters for 3M's PAPRs.
On April 15, CEO Mike Roman was named to the White House task force designated by President Trump to provide recommendations on how best to safely reopen the U.S. economy in the wake of the pandemic.'
On April 16 3M announced a $20 million donation to global COVID-19 public health initiatives. $10 million will go to the COVID-19 Fund for Community Health, $5 million to United Way's COVID-19 Community Response and Recovery Fund, and $5 million to R&D initiatives at education institutions around the globe.
The company filed legal actions on April 31 against 1 Ignite Capital, TAC2 Global, King Law Center Chartered, Zachary Puznak and affiliates Zenger and ZeroAqua, and Hulomil for offering to sell N95 respirators at inflated prices and falsely affiliating with 3M.
On May 11, 3M won two contracts with the Department of Defense to further expand N95 mask production in the U.S. It will allow production of 39 million more respirators a month—nearly tripling production to over 95 million per month.
The company filed legal action in California on June 9 against an Amazon seller charging as much as 20 times the N95 respirator list price for fake, defective, and damaged repirators. Amazon has blocked the accounts on its platform.
Terumo BCT's Spectra Optua apheresis system, combined with Marker Therapeutics' D2000 adsorption cartridge, was granted emerency use authorization to treat COVID-19 positive adults in the ICU with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels.
The company confirmed a contract with the UK government on April 1 to build OxVent ventilators, which are designed to allow for large scale production. OxVent ventilators are the result of joint collaboration between Smith+Nephew, the University of Oxford, and King's College London. The ventilator is under review by the Medicines and Healthcare products Regulatory Authority (MHRA).
Beginning April 13, Dentsply Sirona salaried employees above a certain pay level are taking a 25 percent pay cut for 90 days, including members of the executive team.
At the end of February, Canon Medical began developing a rapid genetic testing system for the novel coronavirus. The project is part of a research program focusing on the development of diagnostic methods for COVID-19 led by the Japan Agency for Medical Research and Development.
As of April 28, Intuitive and the Intuitive Foundation have built or sourced over 100,000 pieces of PPE. The Intuitive Foundation also launched a DIY face mask initiative.
On March 5, the company announced Germany’s Hannover Medical School had developed a molecular assay to detect SARS-CoV-2 on its automated Panther Fusion system. Three days later, BARDA contributed $699,000 to accelerate Hologic’s development of the high-throughput test. According to Hologic, their Panther Fusion system can process up to 1,000 tests in 24 hours.
The FDA authorized Hologic's Panther Fusion SARS-CoV-2 assay on March 16. Starting in April, the company expects to produce nearly 600,000 SARS-CoV-2 tests a month.
The firm's Aptima SARS-CoV-2 assay for its fully automated Panther system earned EUA on May 15.
On March 25, Hillrom announced it had more than doubled production of its critical care products. The firm aims to increase production capacity of its Life2000 ventilator five-fold on a yearly basis. Hillrom will also ramp up production of its ICU and med-surg smart hospital beds, as well as its Connex and Spot vital signs monitors and accompanying physical assessment tools and consumables (themometry, probe covers, and blood pressure devices/cuffs).