Here’s a story not often been heard in 2020: A company starts the year with about 50 local employees and by the end of the year its ranks swell to 100. And it’s projecting about 20 percent growth for fiscal 2021.

That’s the case at Columbia-based Ambu Inc., a medical device company that manufactures a range of single-use endoscopes, including the new duodenoscope, marketed as the Ambu aScope Duodeno.

This is just one local example of the progress, professionally and financially, that’s ongoing in the medical device manufacturing industry, which continues to thrive in the face of the pandemic.

Wild Growth

For the layman, duodenoscopes are used for visual examinations of the duodenum and play a key role in the diagnosis and treatment of conditions like gallstones, pancreatitis, tumors and cancer in the bile ducts and/or the pancreas.

In the U.S., duodenoscopes are used in an estimated 600,000 procedures annually.

Ambu plans to market more than 20 new models of the devices during the next three years.

“The quality of the new single-use duodenoscope and other devices are improving dramatically due to improvements in the lens technology that is also used in cell phones,” said Jens Kemp, Ambu vice president for marketing, “as well as other components that are made much more inexpensively than they were 10 years ago.”

The concept of re-useable devices is much different today that the old paradigm in the world of innovation.

“There used to be new models of devices manufactured every several years,” Kemp said. “Today, we create new versions of our products as soon as the latest product is released.”

As its technology has improved, Ambu has grown exponentially, adding more than 1,000 employees globally and 300 nationwide, including about 50 more in Columbia for a local total of 100.

The growth in employees led to the addition of 9,000 square feet to its facility, which now totals 24,000 square feet. However, it hasn’t been able to move in yet, due to COVID-19.

Not surprisingly, all of that good news is showing up on the company’s bottom line. For recently concluded fiscal 2020, Ambu posted nearly $580 million in revenue, which was up 256 percent from fiscal 2019.

“Today, we’re investing heavily in research and development in our quest to be no 1 in the world in what we estimate will be a $2.5 billion market by 2024,” Kemp said.

Seeing Smiles

Another area company that has garnered worldwide attention is The Clear Mask, a product of the Columbia-based Maryland Technology Development Corp.’s (or TEDCO’s) mdPACE program.

Invented in late 2017, The Clear Mark received Food and Drug Administration (FDA) clearance about a month into the COVID-19 shutdown and promptly sold more than 12.5 million units.

“Due to the pandemic, we made the decision to roll out two product lines (a lower-priced consumer/non-medical version, with the medical/FDA cleared model) in April due to the desperate need for masks,” said Alyssa Dittmar, president. “We wanted to make available consumer masks that were more affordable, especially for schools and small clinics, which could be used in other environments in addition to health care.

The firm has expanded from the original four co-founders to more than 250 staff. Like Ambu, The Clear Mask, which is headquartered in Baltimore, runs manufacturing and fulfillment operations domestically and overseas, and is working with several national government and regulatory concerns.

While the product is about safety, it’s just as much about communication.

“It calms anxious patients through a visible, reassuring smile at the hospital; connects educators and child care professionals with their students and children; and provides critical accessibility to the 48 million Americans who have hearing loss,” said Dittmar, who is deaf, “including older people, those with dementia, veterans and many more.”


Other local companies are involved in the sales and marketing side of the medical device industry, such as Arnold-based DJL Medical Technologies. Once involved in genetic testing technologies and telemetry systems for hospitals, it now markets COVID-19 lgG and lgM Rapid Serology Fingerstick Antibody Test Kits.

The antigen version is approved for point-of-care use (while the antibody test is not). It offers reliable results in 10 minutes that remain valid for 20 minutes. “The antigen test is taking off, since it does not have the requirement of lab testing,” said Jim Laite, principal.

“We’ve been selling [the kits] to hospitals and to doctors’ offices and we’re now talking to airports,” he said. “United Airlines is starting to do testing before any European flights and we hope to talk with Maryland Aviation Administration officials soon.”

While the antibody test is not selling as well, Laite added that DJL is also marketing a mass telethermograph, which is a temperature scanner that can check several people simultaneously as they enter an office building and has “a 99.5 success rate within one-tenth of a degree.”

Maryland Rates

As these companies and many others help anchor a solid sector in Maryland, concerns in other parts of the U.S. have noticed.

While the Midwest and Mountain states are often considered the top regions in the country for the medical device industry, Larry Gigerich, executive managing partner for Fishers, Ind.-based site selection firm Ginovus, added, “We also consider the mid-Atlantic a very attractive market.”

Maryland, Gigerich said, is positioned “very well for life sciences concerns,” since it’s home to such institutions as the National Institutes of Health, the Johns Hopkins network, Fort Detrick and boasts an educated workforce. “In fact, we’re seeing a shift from New York and New Jersey to, in some cases, Maryland and Virginia, which offer less expensive real estate and talent.

He said, “The personal income tax hikes coming online in New York and New Jersey are pushing companies out of those states,” noting that Maryland Gov. Larry Hogan “has done a great job of putting the state back on the radar for economic development.”

And that’s all good for companies like The Clear Mask and Ambu, which are making huge strides in the face of, and not because of, COVID-19.

What Ambu does is “about not having to transport the endoscopes for cleaning. That helps the health care workers,” said Kemp. “While COVID-19 has brought more awareness to cleaning protocols, more hospitals are seeing the value in going the single-use route.”

By Mark R. Smith | Senior Writer | The Business Monthly | December 2020 Issue