Medical Device Manufacturer Embody Sets Stage for International Growth
For Norfolk-based Embody, Inc., the six-year process of product development, preclinical testing, and compliance hurdles to get its collagen-based tendon and ligament implant, Tapestry, into the U.S. market helped set the stage for the lengthy international regulatory process ahead.
From the beginning of the product’s development, the team knew there would be a major overseas market for its bioengineered solution. Not only did Tapestry present a stronger, more biologically advanced alternative to currently available implants, it provided an option for areas outside the U.S. that avoid typical tendon repair solutions due to religious objections around the use of grafts based on human or animal tissue.
“Although the U.S. is a leader particularly in medical device technology innovation, the global market plays a key role in the utilization of these products,” said Rob Brown, Embody’s chief commercial officer.
To begin its entry into the overseas market, Embody targeted Europe, which Brown notes is “probably the second-largest consumer of medical device products, particularly in orthopedics and sports medicine.” However, Europe’s medical device regulations had completed a decades-long update in 2021, creating a more stringent process for compliance.
Perhaps the biggest difference between FDA compliance and the process for securing CE marking — which signifies a product’s conformity with European Union health, safety, and environmental protection standards — is that Europe’s medical device regulations allow clinical data only. The U.S. allows for the use of preclinical data to demonstrate a medical product’s efficacy.
“We are gathering clinical data now in the United States, which will be supportive data for when we go to register our device outside the U.S.,” Brown said. He predicts that Embody is roughly two years out from securing its CE marking. That provides two years of opportunity to assess overseas markets and build connections to ensure a robust sales channel as soon as the product is approved for use.
Brown’s history in supporting medical device sales in large organizations and international startups has shown him the importance of building connections early to support future international sales. To this end, Embody reached out to VEDP’s International Trade team for overseas support.
Embody’s leadership had a fair idea of the support available from the state. The technology behind the company had been born in the biomedical engineering labs of Virginia Commonwealth University and has grown at the Innovation Research Park at Old Dominion University (ODU). The Innovation Research Park is home to a range of technology and health companies, a business incubator, and proximity to ODU research expertise, federal labs, and military centers able to aid companies at every point of their development cycle. These resources have helped the company at every stage of its growth.
In 2017, Embody was the first recipient under Norfolk’s “Innovation Fund,” which the city’s economic development authority called the first municipal venture-capital fund in Virginia. The company has also leveraged millions in grants from the Arlington-based Defense Advanced Research Projects Agency, the Virginia Innovation Partnership Corp.’s Commonwealth Research Commercialization Fund, and Virginia Catalyst, which supports collaboration between Virginia research universities and bioscience firms through funding. It only made sense to turn to Virginia resources as the company prepared to enter overseas markets.
Rob Brown Chief Commercial Officer, Embody, Inc.
Being able to capitalize and leverage the resources available through the state of Virginia can help us accelerate not only our plan, but potentially increase the likelihood of success as we start that path of distribution beyond the United States.
“The biggest benefit has been being able to leverage the capabilities of VEDP to make some connections, particularly with market research,” Brown said. VEDP’s team of international research consultants covers more than 85 countries and provides support to Virginia businesses with individual market assessments that gauge opportunity in specific international markets. This might include compiling background information, identifying potential representatives, or even arranging appointments with likely distributors.
For Embody, the first step was an analysis of opportunity for Tapestry in the United Kingdom. “It makes it easier in that [the VEDP team] has been able to bring forward individuals who are immersed in those local markets where we may not have had formative relationships,” Brown said. “They’ve been able to help us make strong connections.”
In January 2021, Embody was among 10 companies selected to participate in the two-year Virginia Leaders in Export Trade (VALET) Program. VALET supports companies with export planning services tailored to meet their international goals. A team of international public and private service providers contributes expertise to help position companies for overseas success.
While Embody is planning its first international trade mission for 2022, VALET has already helped the company gain some exposure to the international scene. With funding support through VALET, Embody exhibited at the American Academy of Orthopedic Surgeons’ 2021 Annual Meeting in San Diego, “probably the biggest meeting in the world for orthopedics,” Brown said, and has plans to return in 2022. “Those kinds of things are helpful for a company in our stage,” Brown added.
This type of exposure is a valuable stepping stone for entering overseas markets and the type of sustainable growth critical for long-term success. “We’re positioning ourselves to be a company that’s not just successful in the United States, but a company that has potential to expand globally,” Brown said. “Being able to capitalize and leverage the resources available through the state of Virginia can help us accelerate not only our plan, but potentially increase the likelihood of success as we start that path of distribution beyond the United States.”
That success, in turn, stands to impact countless more individuals around the world seeking relief from tendon injuries.