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03 Op-Ed Real Clear Health: As Demand for Masks and Protective Gear Surges, Medtech Steps Up

11 Press Release: COVID-19 Test Availability Rapidly Scales Up

05 Letter To FEMA: Re: Recommendation to Centralize Procurement and Allocation Decision-Making of Ventilators

14 Member Company Response Effort: A Compilation of Individual Company Efforts to Combat Coronavirus

07 Press Release: Tens of Thousands of Life-Saving Ventilators On Deck To Combat COVID-19

21 Medtech on the Frontlines: Advamed Principles

09 Press Release: Advamed Applauds Congressional Passage of Cares Act

22 Op-Ed RealClear Health: COVID-19 Shutdown Reveals Telehealth Importance

23 Press Release: Non-Invasive Ventilators Offer Life-Saving Treatment for Less Severe COVID Patients

TABLE OF CONTENTS

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By Scott Whitaker

March 24, 2020

The national coronavirus outbreak has caused a ripple wave of uncertainty that leaves no

American spared from worry. The threat the virus represents to public health is real, and that is

why the first steps individuals and communities take in mitigating and preventing the spread of

this virus are critical. The U.S. medical technology (medtech) industry has quickly galvanized to

respond to this crisis, with a focus on producing and distributing the personal protective

equipment (i.e., masks, gloves, and gowns), diagnostic tests, and ventilators to communities

battling the pandemic.

Supply-and-demand dynamics change drastically in times of turmoil, and they’re often

unpredictable. This trend has extended to the medical technology industry. Hospitals and other

health care providers are asking for unprecedented numbers of personal protective equipment

(PPE), but in this instance, Americans should feel reassured that demand levels will be met.

In recent weeks, medtech companies have been working around the clock to elevate production

and meet the incredible surge necessary to help protect citizens and health care workers

throughout the United States and across the world. For example, 3M is running manufacturing

shifts 24 hours a day, and they’ve hired new workers to run additional production lines.Owens &

Minor has invested heavily in additional resources to expand North American manufacturing

capacity for its HALYARD-branded PPE, including N95 respirator masks, as rapidly as possible.

In addition, early supply chain challenges stemming from shut down facilities in China where the

coronavirus outbreak originated are beginning to resolve themselves - Medline’s Wuhan PPE

manufacturing plant is scheduled to be back up and running this week. Just last week, the Office

of the U.S. Trade Representative eased shipment of those China-based products back into the

U.S. by eliminating burdensome import tariffs.

OP-ED REAL CLEAR HEALTH: AS DEMAND FOR MASKS AND PROTECTIVE GEAR SURGES, MEDTECH STEPS UP

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These PPEs can mean the difference between a doctor or a nurse contracting the coronavirus

and remaining healthy; they can mean the difference between a fully staffed hospital and a

skeleton crew; sometimes, they can mean the difference between life and death. That’s why the

medical technology industry is committed to doing whatever is necessary to increase

production, streamline dissemination and avoid shortages at all costs.

These efforts are already proving successful and the value will only compound in the coming

weeks. Even in the event of a spike in COVID-19 transmissions, medtech is working 24/7 to help

ensure American communities will be able to access to the PPEs they need to stay safe.

Notwithstanding recent ramp-ups, the industry – in partnership with the federal government

and state and local governments – has been prepared. Medtech helps stock and maintain the

Strategic National Stockpile (SNS) – secure warehouses of pre-packed and transport-ready

containers of critical medical supplies, including PPEs. Already, states like Washington, Missouri,

Delaware and Louisiana have requested PPEs from the SNS, and their requests have been

granted.

But most recently, the medtech industry is seeking out entirely new supply chains. We’re

exploring ways to repurpose, retrofit, and reimagine the production of PPEs. Factories that

typically make shoes and underwear and diapers are being retooled to make surgical gowns and

gloves. Industrial paint masks and automotive respirators are being transformed into health

care-specific safety masks.

All of this informs more than just supply-and-demand economics. It’s proof that when we work

together, we get more done. There’s immeasurable value and strength in unity. Even once this

pandemic is under control, the medical technology industry will continue to leverage

collaboration to solve the world’s most pressing health challenges. We won’t stop adapting and

improving. And we’ll be even more prepared for our next big obstacle because of it.

Originally published at RealClear Health

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March 24, 2020

The Honorable Peter T. Gaynor

Administrator

Federal Emergency Management Agency

500 C Street SW

Washington, DC 20024

RE: Recommendation to Centralize Procurement and Allocation Decision-making of Ventilators

Dear Administrator Gaynor:

I write to you on behalf of the Advanced Medical Technology Association (AdvaMed). Many of

our members are manufacturers of medical devices that are critical in the diagnosis and

treatment of Covid-19, including ventilators, diagnostic tests, and other devices. We are well

aware of the Administration’s efforts to encourage industry to increase the production of

products that are desperately needed to contain the virus and treat its victims. I will be

communicating with you regarding a range of products, but the focus of this letter concerns

ventilators.

Our membership includes major manufacturers of ventilators for use by patients in the United

States. Their products have been subjected to rigorous review by the Food and Drug

Administration for safety and effectiveness. They are the finest in the world. I cannot stress

enough that the limitations on supplying ventilators are not because of decisions by these

companies to produce fewer than they can. They are trying to produce as many ventilators as

possible, including significant production increases. However, they are facing unprecedented

demand for these complex products from health care providers all over the United States and

the world.

Regarding the distribution of devices, there are two fundamental challenges. First, there are

problems in allocating devices to health care providers who need them most. Many health care

providers, as well as state and local governments, are trying to buy ventilators. Some of these

LETTER TO FEMA: RE: RECOMMENDATION TO CENTRALIZE PROCUREMENT AND ALLOCATION DECISION-MAKING OF VENTILATORS

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potential purchasers should have a higher priority than others based on the acuity of patient

needs in their areas. It is difficult for manufacturers to establish these priorities. We would

appreciate the Administration’s leadership and the advice of clinical and other experts within the

Administration in deciding how to allocate these products in the most effective way.

Second, it is difficult in many cases to determine which source of products – a particular

manufacturer, the Strategic National Stockpile, or other sources of inventory – can most

efficiently provide products to certain users. These decisions can most effectively be made by a

single federal coordinating entity that has information about possible sources of devices and the

needs of individual users.

We believe the most effective way to address these allocation issues is for the Administration to

designate a lead agency, such as FEMA, to oversee these allocation decisions with the active

input of clinical experts, including the CDC, and other stakeholders, including members of the

health care community, patient advocacy groups, and industry. Manufacturers of ventilators

would then commit to supply their production of these products for the U.S. to the Strategic

National Stockpile, which would be distributed by or under the direction of FEMA or whatever

lead agency is designated. Manufacturers would provide support to users of the distributed

devices in installation, servicing, and training of appropriate employees in the use of the devices.

I welcome any opportunity to facilitate the advancement of a centralized acquisition and

allocation framework or to dialogue on alternatives that you may be considering. Thank you for

your time and consideration. I look forward to communicating with you further on our

recommendations. Please do not hesitate to contact me at (202) 783-8700 or

SWhitaker@advamed.org with any questions or concerns.

Sincerely,

Scott Whitaker

cc: The Honorable Michael R. Pence, The Vice President

The Honorable Alex M. Azar II, Secretary, U.S. Department of Health and Human Services

Original letter available at AdvaMed.org

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April 1, 2020

Key medtech sector pushes the limits of capacity to produce unprecedented numbers of respiratory

medical devices

WASHINGTON, D.C. – The

Advanced Medical

Technology Association

announced today that its

member respiratory device

companies have dramatically

expanded the limits of their

present production capacity

in responding to the

coronavirus outbreak,

producing on average 2,000-

3,000 ventilators per week,

collectively, according to a

recent survey of the seven

member companies. In the

coming weeks, company

officials expect to ramp

production to

unprecedented levels,

producing between an aggregated 5,000 and 7,000 ventilators per week in meeting the greatest

needs across the nation. In 2019, when tallied together, these same companies were

manufacturing approximately 700 ventilators per week for domestic distribution.

PRESS RELEASE: TENS OF THOUSANDS OF LIFE-SAVING VENTILATORS ON DECK TO COMBAT COVID-19

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“This historic response is nothing short of extraordinary,” said Scott Whitaker, president and

CEO of AdvaMed. “Across the board, our ventilator members have boosted production by more

than 285 percent to meet the demands of this global crisis. Through it all, our partners in

government agencies have worked hard alongside our industry to help where we’ve needed it

most, speeding approvals and fast-tracking the production of these sophisticated life-saving

devices so manufacturers can get them where they are needed.”

In a survey conducted by AdvaMed from March 25-31, member companies reported that they

have added entire new manufacturing lines, repurposed existing manufacturing lines for less

essential equipment, trained and reoriented engineers, and added new employees to meet the

enormous demand for ventilators. Still other companies have added new shift lines to

production, and others are partnering with third parties to explore opportunities to enhance

supply chains and forming creative partnerships with other industries. Analysts predict these

new capacities will yield as many as 5,000 and 7,000 invasive, COVID-related ventilators per

week during the second quarter of 2020. This estimation of production does not include

recently announced partnerships with groups such as the automotive industry.

According to the CDC, a low but significant number of patients with COVID-19 may see their

symptoms worsen with progression to lower respiratory tract disease. Many are diagnosed with

pneumonia and subsequently develop hypoxemic respiratory failure or acute respiratory

distress syndrome (ARDS). These patients are primarily treated with mechanical ventilation, both

invasive and non-invasive, often with supplemental oxygen. AdvaMed companies such as

Draeger, GE Healthcare, Hillrom, Medtronic, Philips, ResMed and Vyaire Medical manufacture

ventilators – along with other respiratory devices – in the treatment of COVID-19 patients.

###

Original press release available at AdvaMed.org

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March 27, 2020

WASHINGTON, D.C. – Today, AdvaMed President and CEO Scott Whitaker released a statement

applauding congressional passage of the Coronavirus Aid, Relief, and Economic Security

(CARES) Act.

“These are extraordinary times, and we appreciate Congress for responding in an extraordinary

way,” said Scott Whitaker, President and CEO of AdvaMed. “The latest relief package will help

keep medical technology manufacturers afloat in the face of economic turmoil, and it will enable

them to operate at the highest possible levels to combat COVID-19. Patients and the global

health care system are counting on our industry to continue delivering the tools they need to

prevent, diagnose, and treat this disease. Thanks to quick action by Congress and the

administration, we feel even more confident in our ability to do just that. Still, many small

medical technology companies may need additional help, and we look forward to working with

Congress and the administration on that front as they consider future relief legislation.”

The CARES Act includes several key provisions to aid medical technology manufacturers.

• In order to preempt supply chain and device shortages, CARES requires the strategic national

stockpile to include certain medical devices necessary for diagnosing and treating COVID-19. It

adds $16 billion in federal funding for the Strategic National Stockpile for medical supplies,

personal protective equipment and medicine.

• CARES provides permanent liability protection for manufacturers of personal respiratory

protective equipment, such as masks and respirators, in the event of a public health emergency.

• CARES extends the 50/50 transition payment amount for durable medical equipment (DME)

provided in rural areas through the end of the public emergency period and creates 75/25

transition payment amount for DME items provided in non-CBA areas.

PRESS RELEASE: ADVAMED APPLAUDS CONGRESSIONAL PASSAGE OF CARES ACT

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Additionally, CARES includes several positive tax and payment relief provisions for medical

technology manufacturers.

• CARES delays private payer data reporting for laboratory payment purposes for one year (January

– March 2022) and freezes payment rates for 2021 at the 2020 levels.

• CARES offers net operating loss tax relief; NOLs from tax years 2018, 2019, or 2020 may be

carried back five years. It also offers funding to reimburse providers for health care related

expenses or lost revenues that are directly attributable to the coronavirus.

• CARES will expand an existing Medicare accelerated payment program for the duration of the

COVID-19 emergency period.

###

Original press release available at AdvaMed.org

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March 31, 2020

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today released

the following statements by Scott Whitaker, AdvaMed president and CEO, and Susan Van Meter,

executive director of AdvaMedDx, regarding the medtech industry’s ongoing response to the

coronavirus pandemic:

“Within just the last few weeks, 17 diagnostics companies have received FDA Emergency Use

Authorizations (EUA) and are rapidly scaling up capacity for COVID-19 testing,” said Scott

Whitaker, president and CEO of AdvaMed. “All of this has happened in a matter of days since the

first commercial IVD for the coronavirus received FDA authorization on March 12, thanks to the

fast work of many of our member companies and, just as critically, FDA.

“So far, hundreds of thousands of COVID-19 tests have been performed. Millions are now

available, including several point-of-care tests that provide results in under an hour, and one

that takes just five minutes. By mid-April, monthly capacity for commercial COVID-19 tests will

be in the tens of millions. It’s an incredible accomplishment. And more are on the way.”

“AdvaMedDx member companies are supporting large reference laboratories, hospital

laboratories, and increasingly – with greater availability of rapid, point-of-care tests – emergency

departments, physician offices, urgent care facilities and clinics,” said Susan Van Meter, executive

director of AdvaMedDx. “All these tests complement one another across the health care delivery

system. We commend the remarkable work that health care providers and the laboratory

community are doing to perform these essential tests,” Van Meter said.

“Medtech companies on the front lines of the coronavirus crisis are working 24/7, doing

absolutely everything they can to make sure everyone has access to the tools they need to

PRESS RELEASE: COVID-19 TEST AVAILABILITY RAPIDLY SCALES UP

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prevent, diagnose and treat this disease,” Whitaker continued. “They’ve significantly increased

production of essential equipment and supplies, including personal protective equipment (PPE)

and ventilators.

“As the entire medtech industry continues to do all we can to address the COVID-19 pandemic,

we also commend the hard work and support of the White House task force, HHS, FDA, CDC,

FEMA, Congress, and other key officials. We will continue to work with them and all

stakeholders to facilitate patient access to medtech during this crisis,” Whitaker concluded.

For more information on the medtech industry’s response to the COVID-19 pandemic,

click here. For a listing of currently available coronavirus tests, see below.

Tests that have received EUAs from FDA for COVID-19 include:

• Roche’s Cobas SARS-CoV-2 Test.

• Hologic’s Panther Fusion SARS-CoV-2 test.

• Quidel's Lyra SARS-CoV-2 Assay.

• Thermo Fisher's TaqPath COVID-19 Combo Kit.

• Abbott's RealTime SARS-CoV-2 test.

• Abbott’s ID Now COVID-19 test.

• DiaSorin's Simplexa COVID-19 Direct assay.

• GenMark’s ePlex Test.

• Cepheid’s Xpert Xpress SARS-CoV-2 Test.

• Primerdesign’s COVID-19 Genesig Real-Time PCR Assay.

• BioFire Defense’s COVID-19 Test.

• Mesa Biotech’s Accula SARS-Cov-2 Test.

• Perkin Elmer’s New Coronavirus Nucleic Acid Detection Kit.

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• BGI Genomics’s RT-PCR Kit.

• Luminex’s NxTAG CoV Extended Panel Assay.

• NeuMoDx’s SARS-CoV-2 Assay.

• Qiagen’s QIAstat-Dx Respiratory SARS-CoV-2 Panel.

Additional COVID-19 IVDs that are available and being performed around the country, and in

the process of securing EUAs, include:

• BD’s and BioGx’s SARS-CoV-2 test for the BD MAX System.

• Co-Diagnostics’s Logix Smart test.

# # #

Original press release available at AdvaMed.org

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Since the onset of the coronavirus (COVID-19) outbreak, AdvaMed member companies have

donated millions of dollars’ worth of medical products and cash to hospitals, foundations and

charities around the world. Medical device companies are responding to increased demand by

ramping up production wherever possible, coordinating closely with governments to ensure the

delivery of supplies where they are most needed, and in some cases, creating new devices and

diagnostic tests to help effectively diagnose and treat sick patients.

Below is a collection of some of the efforts undertaken recently by AdvaMed member

companies based on public statements as of April 20, 2020.

View a list of companies that have developed IVDs that have received Emergency Use Authorization

from the U.S. Food and Drug Administration.

3M has ramped up to maximum production of N95 respirators, doubling their global output to a

rate of 1.1 billion per year, or 100 million per month. This includes 35 million per month in the

United States, and over just the last seven days (as of March 31) has delivered 10 million N95

respirators to healthcare facilities in states across the country.

3M plans to double their capacity to reach 2 billion globally within the next 12 months – and

some of that additional capacity will begin to come online in the next 60-90 days.

In the United States, 3M expects to be producing N95 respirators at a rate of 50 million per

month in June, a 40 percent increase from current levels. Read More.

Abbott has received emergency use authorization (EUA) from the FDA for its molecular test for

the identification of SARS-CoV-2, the virus that causes COVID-19.

The company is deploying 150,000 laboratory tests immediately. Tests already have been sent

to hospital and academic medical center labs in 18 states including Illinois, California, New York,

MEMBER COMPANY RESPONSE EFFORT: A COMPILATION OF INDIVIDUAL COMPANY EFFORTS TO COMBAT CORONAVIRUS

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Massachusetts and Washington. Abbott is scaling up production at its U.S. manufacturing

location to reach capacity for one million tests per week by end of March. Read more.

Baxter is committed to working with global partners to ramp up production of PPE for health

care providers, patients, and their employees, the company reported April 2. The company has

also committed resources to relief organizations helping to promote telemedicine opportunities

and mobilize critical supplies, among other activities, and is matching employee donations to

selected nonprofit partners by 2:1. Read more.

Bayer is donating funds to Spain for hospital beds and medical equipment to fight the corona

pandemic, as well as testing equipment. The donation is worth an aggregate of about 1M euros,

the firm announced April 8. Read more. The package is one of numerous Bayer efforts

worldwide. The firm is also supporting hospitals in Lombardy, Italy, with a donation of 1M euros,

the firm announced March 18. The funds will support regional authorities in procurement of

equipment for intensive care units in hospitals with the greatest needs. Read more. Earlier this

year, the firm sent financial and material support to China valued at about EUR 1.5M to help

contain the pandemic. Read more.

B. Braun Medical announced April 13, 2020, it received FDA emergency use authorization (EUA)

for use of infusion pumps with nebulizers to treat COVID-19 patients. The alternative treatment

will allow continuous medication to be delivered into a nebulizer for critically ill COVID-19

patients while decreasing exposure to health care providers. Read the press release.

BD (Becton, Dickinson and Company) and BioGX Inc, a molecular diagnostics company,

announced April 3 they have received FDA Emergency Use Authorization (EUA) for a COVID-19

diagnostic that returns results in under three hours using the BD MAX automated molecular

diagnostic platform. The platform is already in use at hundreds of labs in nearly every U.S. state,

with each unit capable of analyzing hundreds of samples per day. Read the press release.

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BD CEO and President Tom Polen stated following a White House meeting March 13, “We are

working around the clock internally and with external partners to increase the coronavirus

diagnostic capacity in the U.S by ramping up production of our sample collection tools and

increasing access to our automated molecular platform for in vitro diagnostics.” As of March 23,

BD also reported contributing over $1M for COVID-19 response efforts, including $350,000 in

cash and company product donations for relief efforts in China earlier in the year. View the

press release.

Boston Scientific has donated more than $2M in supplies to hospitals, including PPE, to meet

urgent needs of health care providers, according to the company. In addition, Boston Scientific is

collaborating with the University of Minnesota Bakken Medical Device Center on a ventilator

alternative to replace manual respiration in emergency settings by using a robot to pump an

Ambu® bag. The firm is also collaborating with the University of Minnesota to develop a

reusable personal respirator and PPE. Read more.

BioMérieux received an EUA from FDA for use of its BIOFIRE® COVID-19 test in moderate and

high complexity clinical laboratories to detect SARS-CoV-2, the firm announced March 24. The

test uses nasopharyngeal swabs and provides results in about 45 minutes on the firm’s nearly

11,000 BIOFIRE® systems worldwide. Read the press release.

Cardinal Health is collaborating with suppliers to increase product supply, and partnering closely

with trade groups including AdvaMed, the Health Industry Distributors Association, Healthcare

Distribution Alliance, National Community Pharmacists Association, National Association of

Chain Drug Stores, and Healthcare Ready to respond to industry-wide challenges. Read more.

Cepheid’s Xpert® Xpress SARS-CoV-2 rapid molecular diagnostic for COVID-19 became the first

commercially available point-of-care test for the disease upon receipt of an EUA from FDA,

announced March 21. The test is run on Cepheid's installed base of over 23,000 automated

GeneXpert® Systems worldwide, with a detection time of approximately 45 minutes. Read the

press release.

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Danaher Corporation: Five Danaher operating companies donated RMB 10 million ($1.4M) of

diagnostic equipment, reagents and other products to hospitals in Wuhan, China to combat

COVID-19. Included in the donation is: Beckman Coulter Diagnostics' hematology analyzers,

Beckman Coulter Life Sciences' flow cytometers, Radiometer's blood gas analyzers, Cepheid's

Xpert® Xpress Flu/RSV assay, and Hach's UV-Vis spectrometers.

ExThera's Seraph®100 Microbind® Affinity Blood Filter has received FDA Emergency Use

Authorization (EUA) for treating COVID-19, the firm reported April 17, 2020. The blood

purification therapy binds and removes SARS-CoV-2 virus/RNA while improving vital signs and

laboratory parameters associated with inflammation and tissue damage, the company explains.

Read more. The device received a European CE Mark in 2019 for reduction of pathogens in

blood, and is widely available in Europe. Read more.

GE Healthcare CEO Kieran Murphy shared on March 6 that the company is accelerating

manufacturing, with plans to rapidly deliver around 1,000 pieces of technology, such as CTs,

ultrasounds, monitors and ventilators, among several other response efforts. Read more. GE

Healthcare announced March 24 that since the COVID-19 outbreak began, the company has

doubled its capacity of ventilator production and has plans to double it again by mid-year to

address unprecedented demand — independent of its recent collaboration with Ford to scale up

supplies of the devices. Read more.

Hologic created a fully automated test that detects genetic material from SARS-CoV-2, the new

coronavirus strain, in under three hours. The test recently was granted Emergency Use

Authorization (EUA) by the U.S. Food and Drug Administration (FDA). Read more.

Johnson & Johnson has earmarked $50M for COVID-19 response efforts, primarily focused on

supporting frontline health workers. This includes product donations in China, Italy, South

Korea, and more, with over $3.7M in personal protective equipment like goggles, protective suits

and masks. J&J is also working diligently to convert manufacturing lines at several facilities

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around the world to produce hand sanitizer in accordance to FDA and CDC guidelines as quickly

as possible that will help protect R&D, manufacturing and distribution employees, and to be

donated to health and community service workers on the front lines of care. Read more here.

Additionally, J&J is working with partners to develop a vaccine. Read more here and here.

The Lilly Foundation contributed $500,000 to United Way of Central Indiana’s Community

Economic Relief Fund. The fund will support human services organizations and the individuals

and families they serve who are affected directly or indirectly by the COVID-19 virus. The Lilly

Foundation is also providing a 2:1 match for Lilly employee and retiree contributions to the fund.

Lilly and AbCellera agreed to co-develop antibody products for the treatment and prevention of

COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will

leverage AbCellera's rapid pandemic response platform and Lilly's global capabilities for rapid

development, manufacturing and distribution of therapeutic antibodies. Read more.

Medtronic continues to make progress in increasing ventilator production worldwide. As of

March 18, the company reported having increased production over 40 percent, and being on-

track to more than double its capacity to manufacture and supply ventilators in response to

COVID-19. Read more. The firm’s partnership with Baylis Medical, a Canadian-based device

company, will also help produce ventilators for hospitals in Canada, Baylis announced April 7.

Read the press release.

Olympus installed endoscope systems into the Wuhan Huo Shen Shan Hospital within 10 days

to treat infected patients. In addition to monetary donations to the Red Cross Society of China

Huanggang, Olympus has donated 15 sets of laryngoscopes to the China Social Welfare

Foundation, and 25 biological microscopes to the Chinese Center for Disease Control and

Prevention, totaling approximately $500,000 in donations.

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PMT Partners announced April 13 that its small, compact, and portable Oxylator® ventilation-

resuscitation device was successfully used to treat a patient with COVID-19. Read more. Earlier

this year, the firm said it had 1,000 emergency ventilation-resuscitation devices available for

hospitals and emergency medical services.

QIAGEN received FDA Emergency Use Authorization (EUA) for its QIAstat-Dx Respiratory SARS-

CoV-2 Panel test, the firm announced March 31. The test can differentiate COVID-19 from 20

other serious respiratory infections and a provide a result in “about one hour,” according to the

company. Read more.

Quidel's Lyra® SARS-CoV-2 Assay for COVID-19 has received FDA Emergency Use

Authorization (EUA), the firm announced March 17. The RT-PCR test is intended for qualitative

detection of nucleic acid from SARS-CoV-2. Read more. The company subsequently received an

expanded EUA for use of the test on additional platforms and with expanded specimen types, as

well as CE Mark approval and Health Canada authorization for marketing overseas, the firm

announced March 25. Read more.

ResMed CEO Mick Farrell stated March 23 that over 7,500 ResMed employees are working

diligently in over 140 countries with government officials and health care workers to maximize

production and delivery of essential ventilators and other respiratory support devices. The

company is looking to double or triple ventilator output, and scale up ventilation mask

production by tenfold. Read more here. Earlier this year, the firm reported sending over 100

ventilators from its facility near Shanghai to Wuhan, with plans to send hundreds more and

thousands of masks. Read more.

Roche announced on March 13, 2020 that the U.S. FDA has issued an Emergency Use

Authorization (EUA) for the cobas® SARS-CoV-2 test for qualitative detection of the virus that

causes COVID-19 disease. Additionally, Roche has donated medical supplies and financial

support for China's affected region. Read the company's statement.

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Smith+Nephew has been working to support its employees and customers in China. They are

liaising closely with the local authorities, supporting urgent cases and donating product, in

particular from their Advanced Wound Care range, and cash via the Red Cross, in aggregate

worth approximately $250,000. Chief Executive Officer, Roland Diggelmann, shared the

following statement, “Smith+Nephew has been responding to the COVID-19 outbreak for many

weeks, first in China, and now in countries across the world. Our focus is to protect the health

and well-being of our employees while continuing to serve customers. The commitment of our

employees has ensured we have kept our products and services flowing. We stand together

ready to offer assistance during this unprecedented and challenging period.” Read more.

Stryker released a statement on April 6, 2020 that the company has increased production of

hygiene, disinfecting and surgical protection products, as well as hospital beds, stretchers, and

defibrillators. This shift in manufacturing priorities reflects the company’s global dedication to

helping customers so they can focus on taking care of patients.

Additionally, Stryker has developed a low-cost, limited-release emergency response bed to

quickly aid healthcare providers with efficient care during the COVID-19 pandemic. They are

also exploring the viability of decontaminating N95 respirator masks for emergency use in

healthcare settings through their expertise in sustainable solutions. Read more.

Terumo BCT announced April 10, 2020, its receipt of an EUA from FDA for use of its Spectra

Optia Apheresis System combined with Marker Therapeutics’s D2000 Adsorption Cartridge to

reduce pro-inflammatory cytokine levels in adult ICU patients with COVID-19 in cases of

confirmed or imminent respiratory failure. The devices work together to filter cytokines from a

patient's blood. Read the press release.

Varian has donated 1 million RMB to the China Red Cross. View the press release.

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The medical technology industry recognizes its crucial role in our nation’s health care system,

particularly during an unprecedented public health emergency such as the COVID-19 pandemic.

This crisis has united us all as Americans in a global fight. The patients our industry serves have

always been our No. 1 priority, and we are working around the clock to meet their needs. We are

committed as medical technology innovators and manufacturers to working with federal, state,

and local authorities to ensure our nation’s disaster planning efforts are coordinated, efficient,

and effective. For weeks now, the medtech industry has been mobilizing to this global cause,

and we are committed to the following guiding principles in our efforts to conquer the

coronavirus.

• We will continue to increase manufacturing capacity and support policies and industry initiatives

to ensure patients have access to critical medical technologies, partnering with manufacturers

inside and outside our industry.

• We will continue to support our employees and their families in staying healthy so they can

continue to pursue their mission of serving patients and keeping the health care system strong.

• We will work with the administration to provide timely product availability information to health

care institutions and the public, partnering with GPOs, distributors, and hospitals.

• We will leverage our industry’s substantial investments in diagnostics to continue deploying tests,

support our nation’s laboratory infrastructure, and develop point-of-care tests to make rapid

testing widely available to patients.

• We will continue our work with government agencies, health care providers, and payers to

expand patient access to medical technologies, including telemedicine, and to assist with remote

training among medical professionals.

MEDTECH ON THE FRONTLINES: ADVAMED PRINCIPLES

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By Andrew Fish

April 6, 2020

In 2017, 76% of hospitals in the U.S. were connecting health care providers to patients – not to

mention health care providers to fellow providers – via video and other forms of telehealth

technology. It saves time and money, while providing the same, if not better, levels of care

satisfaction.

But in today’s health care reality, as we battle an unprecedented global COVID-19 pandemic,

telehealth has become more than just a convenient, cost-effective supplement. It has become

mission critical. It’s keeping contagious people safe in their homes, thus reducing stress on

hospitals and protecting health care workers from infection.

That’s why, as part of its coronavirus response strategy, the Trump administration has been

focused on lifting barriers to telehealth for Medicare patients: 44 million people across the

country. Rules that limited payments for telehealth visits have been removed. Regulations that

blocked the use of popular applications like FaceTime and Skype have been suspended. Thanks

to these actions and others like it, telehealth is more accessible than it’s ever been.

But to continue to see the benefit of that accessibility, even after this pandemic is under control,

it’s important lawmakers consider a few additional, more permanent steps.

First, as lawmakers expand Medicare beneficiaries’ access to telehealth, they should also expand

Medicare’s existing benefit structure. Medicare’s current benefit structure largely reflects the

time Medicare was created – 1965 – well before smart devices, algorithms, and apps had

entered the public health lexicon. For that reason, many digital medical technologies, including

telehealth technologies, do not fit clearly into existing Medicare benefit categories, posing

significant challenges to gaining coverage and payment. Once Medicare’s outdated benefit

OP-ED REAL CLEAR HEALTH: COVID-19 SHUTDOWN REVEALS TELEHEALTH IMPORTANCE

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structure is modernized, patients will see new technologies available to them, and Medicare will

see cost savings from improvements in care delivery and reductions in inefficiencies.

Second, lawmakers should remove geographic restrictions imposed on Medicare coverage of

telehealth services, so all patients, regardless of their zip code, have the access to telehealth

they deserve. Right now, only patients living in specific rural health professional shortage areas

can take advantage of telehealth services, and most of those patients’ homes are not considered

covered sites. Instead, patients must travel to a clinic, hospital, or health center to receive their

telehealth care, which often eliminates the convenience patients sought in the first place.

Without these unnecessary obstacles to telehealth, all patients – rural or urban; from home or

from a doctor’s office – can benefit from telehealth care.

Finally, just as many states are allowing licensed out-of-state medical professionals to practice in

their communities during the COVID-19 crisis, medical professionals in one state should be

allowed to provide telehealth care in other states during the crisis and beyond. Such a simple

solution could help relieve the strain of specialist shortages across the country. Another

solution: invite all health care providers into the telehealth community. Right now, telehealth

services covered by physical therapists, occupational therapists, speech audiologist, and other

specialists are not covered by Medicare. It’s a huge hindrance for people looking for specific

care.

The coronavirus pandemic has made it increasingly clear: telehealth is the future of health care.

But in order to usher that future in efficiently and effectively, the telehealth regulatory system

needs improvement. We hope that the steps the Trump administration has taken in recent

weeks are only the beginning, and that real, meaningful, permanent reform is on the way. We

stand ready to help make it happen.

Originally published at RealClear Health

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April 9, 2020

WASHINGTON, D.C. – New clinical evidence produced in recent weeks has shown the benefits

of non-invasive ventilators for use in less severe cases of COVID-19-related respiratory

problems, which constitute the majority of cases nationwide. In a series of white papers,

published evidence, and case studies from both China and Italy, experts say many coronavirus

patients with less-severe respiratory distress could benefit from non-invasive ventilation

therapy, thus freeing more invasive ventilation devices for the most critically ill patients

nationwide.

“This could be a game changer in the race to get as many ventilators in the hospitals as we

possibly can,” said Scott Whitaker, President and CEO of AdvaMed. “A large majority of COVID

patients could benefit from these respiratory devices, easing pressure on our critical care system

in hospitals and offering another lifesaving option for tens of thousands of people suffering

from respiratory problems.”

According to the Centers for Disease Control and Prevention (CDC), patients with mild

symptoms of COVID-19 may not initially require hospitalization; however, their symptoms could

worsen and require oxygen supplementation, which can be delivered through non-invasive

ventilation (NIV). NIV is a form of mechanical ventilation where air is delivered to the patient

through a mask or mouthpiece. Invasive ventilation is used when sufficient ventilation cannot be

achieved using non-invasive methods, so oxygen is delivered through a tube inserted into the

trachea either through intubation or tracheotomy. As governments and health administrations

around the world respond to the global demand spike for ventilators, many have now issued

guidance documents on the use of bilevel or BiPAP devices that deliver NIV in patients with

confirmed or suspected COVID-19.

PRESS RELEASE: NON-INVASIVE VENTILATORS OFFER LIFE-SAVING TREATMENT FOR LESS SEVERE COVID PATIENTS

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“There is an increasing amount of clinical guidance coming out of China, Europe, and the U.S.

that positions non-invasive ventilation and invasive ventilation as appropriate, along the

spectrum of patient presentation and care,” said ResMed Chief Medical Officer Carlos M. Nunez,

M.D. ResMed is one of seven AdvaMed member respiratory manufacturers. “These limited

numbers of invasive ventilators can be reserved for the most severe cases by using non-invasive

devices to care for those with less acute respiratory symptoms and findings,” continued Dr.

Nunez.

“With the extraordinary demand for ventilators, both for immediate needs and for future

pandemic planning, our industry’s increased production and delivery of non-invasive ventilators

is already helping to match available supply with the clinical needs of patients,” said Hillrom

President and CEO John Groetelaars, another AdvaMed member company. “This form of

respiratory therapy is ideal for treating patients with mild to moderate respiratory distress

across various acute care settings, including the emergency department, med-surg and post-

ventilator weaning support.”

Wherever hospitals’ capacity and available equipment is insufficient to meet demand, it’s

important to support as many patients as are clinically appropriate on NIV devices. The U.S

National Academy of Medicine indicated that the use of NIV therapy could be a way to forestall

the need for intubation and reduce days on a ventilator. As it is with all clinical decisions,

providers considering NIV therapy for COVID-19 patients must ensure that the appropriate

design mitigations are in place to minimize spread of the disease. Recommendations from the

WHO and the CDC include using negative-pressure isolation rooms for patients, and gloves,

gowns and masks for caregivers.

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A survey of AdvaMed ventilator manufacturers recently found the member companies combined

could produce, on average, 60,000 NIV devices per week by the middle of the second quarter.

This estimate represents an increase from approximately 14,000 per week manufactured

presently, due in large part to the less complex design of the non-invasive construct.

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Original press release available at AdvaMed.org