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Before COVID-19 vaccines were made and distributed, medical device companies that could make testing kits were among the first segments of the healthcare supply industry of critical importance during the pandemic. As hospitals began to fill up in hotspot areas, the worried well—frontline healthcare workers among them—wanted to know if they or the people closest to them were infected.
Richard Rew, former senior vice president, general counsel, and chief compliance officer at Luminex Corporation, was right there in the thick of it. The company had the capabilities for making and distributing some of the PCR (polymerase chain reaction) tests, releasing its first shipment in early March 2020 and a few variations thereof in the months that followed.
“The federal government’s emergency use authorization made it easier,” says Rew. The type of test they initially released was the PCR type, detecting the presence of the viral RNA that appear before antibodies form and patients’ symptoms present—which was highly sought after, particularly early in the pandemic. “We had the expertise and respiratory panels, which tests for other respiratory diseases to rule out other causes.”
To be clear, there were bureaucratic issues with the government’s response at that point. Private sector companies such as Luminex, ready and quite willing to go into production ASAP, were stymied then by a lack of coordination between different agencies that are charged with epidemic surveillance and solutions.
So once that was overcome, the company had to ramp up production quickly, facing other sets of regulatory and legal hurdles. Pandemic notwithstanding, it was all in a day’s work for the Luminex legal team.
It helped Rew that this wasn’t his first medical devices company, and it probably won’t be his last. In the summer of 2021, the company was acquired by DiaSorin, an Italy-based, global diagnostics life sciences company, leading to the elimination of his position due to redundancy.
He was intimately involved with the merger—providing counsel to the board of directors, shareholder votes, and the like—and in this international transaction, he also dealt with issues around CFIUS, the Committee on Foreign Investment in the United States. The Committee is how the federal government reviews mergers of this nature as they might affect national security.
Given that Rew lives in Austin, Texas, he’s confident he’ll find his next engagement without having to move. The city has no fewer than sixty-two biotech, pharmaceutical, and life sciences companies based there, all of which exist in the high-stakes—and highly regulated—healthcare industry.
“It helps to like what you’re doing and to like the people you work with. Hard work and the issues you deal with are not so bad if you like the industry.”
The coronavirus wasn’t even the first novel infectious disease he has worked with. The Zika fever epidemic, which first surfaced in 2015, was on Luminex’s radar such that the company performed preliminary research and regulatory work.
As a leader, Rew has a strategy that includes choosing people who “have more talent than me,” as he puts it. “I’ve hired a lot of future general counsel. Not many people will turn down a medical device company job in Austin. The city is booming with lots of sophisticated work. I just try to give them the opportunity to do sophisticated things, to grow their skills.”
Reflecting the size and diversity of the health sciences sector in the Texas capital (and home to the University of Texas), he also notes that the vibrancy of the city is attractive to young professionals, providing a healthy talent pool from which to draw ambitious attorneys.
As for the kinds of things he is able to teach them, he advises, “You have to be a meaningful member of the business.” He’s also served, as do many in the general counsel position, as the corporate secretary—by definition, the person interpreting and recording the decisions in board meetings. “You have to know what legal guidance they [board members and C-level executives] need, and understand the relationships between them.”
But it’s also important in healthcare for the legal team, from top to bottom, to keep an eye on the regulatory environment as they advise senior management. “Keep in mind the Department of Justice prosecutes executives,” he says. Things to watch for include antikickback statutes, anything from the Food and Drug Administration, misbranding of products, and violations relating to the Foreign Corrupt Practices Act.
While many attorneys in healthcare themselves might begin their careers in the health sciences, Rew says it’s not entirely necessary, citing himself as an example. His best advice is to, like him, find an industry that is interesting. “It helps to like what you’re doing and to like the people you work with,” he says. “Hard work and the issues you deal with are not so bad if you like the industry.”
Living in Austin, however, might also help.
