Thema, a CompLife Italia Group company, is a medical device consultancy located in the Northern Italian town of Imola, in the Metropolitan City of Bologna. A visit to Philadelphia in November 2023 by a four-person delegation led by Thema Founder and CEO Marisa Testa resulted in the company’s first U.S. expansion.

The journey to our region began with a conference and an introduction to the Chamber of Commerce for Greater Philadelphia (the Chamber) from the Pennsylvania Department of Community and Economic Development (DCED).

“We got in touch with Pennsylvania and Philadelphia by chance because I attended a medical device event in Mirandola, near Modena, here in Emilia-Romagna,” Testa said. There, in Italy’s biomedical district, she learned of a partnership between Emilia-Romagna and Pennsylvania.

“This was the right moment for us because we did a market analysis in the U.S. and established that the eastern part of the U.S. was very interesting to us,” Testa said. “The important thing for us was to find a well-established location with many medical device companies.”

Testa connected with Pennsylvania’s representative in Italy, located in Bologna, who worked with the Chamber’s Manager of Business Attraction & Expansion, Lindsey Hover, to arrange a visit to the Greater Philadelphia region. Hover, in tandem with DCED and the City of Philadelphia, got right to work with an itinerary for the Thema delegation’s two-day tour, which included meetings with the state’s Office of International Business Development, the City of Philadelphia Department of Commerce, Life Sciences PA, and local immigration attorneys.

“We were so surprised about the organization and also how useful the visit was,” Testa said. “They scheduled meetings with advisers and brought us to see possible locations for our office. Also, the Italian Consul was there to meet us. It was so useful.”

The Chamber, along with City of Philadelphia and Pennsylvania representatives, also invited the delegation to a networking event at Venture Cafe Philadelphia to make contact with potential prospects, “and it was amazing,” Testa said.

Establishing Thema’s U.S. HQ at B+labs

“So friendly,” is how Testa described her first impression of Greater Philadelphia. “There is a complete trust of people. They are very connected one with the other. And they really do want to network,” she said.

“We fell in love with Philadelphia because there is a great hub there of healthcare companies,” Testa said, and an atmosphere that is “interesting and sparkling.”

“We decided to establish our company in Philadelphia and we located an office in B+labs in the Cira Centre, and we are trying to develop our business from there.”

In February 2024, Thema signed their lease, establishing the company’s U.S. office at the B+labs science incubator, a partnership between Chamber investor Brandywine Realty Trust and member the Pennsylvania Biotechnology Center in the region’s Schuylkill Yards innovation development. From its U.S. home base at B+labs, Thema will work with clients to boost market growth, ensure compliance with the regulatory standards for their medical and in vitro diagnostic devices, and support market registrations in the U.S., European Union, and worldwide.

“When I got the notice that Thema signed the lease with B+labs, I was overjoyed, and I can’t wait to get them integrated into the region,” Hover said.

Thema’s Beginnings

Testa founded Thema in 2007 after earning a law degree and gaining experience working in the medical device industry. She developed a passion for the regulatory side of the business, born from a desire to help patients.

“The compliance, and putting into the market safely-made devices, make me feel as if I am contributing to the health of people. I want to promote and improve that, and this is the way I can accomplish my mission and vision for that,” she said.

“I saw at the time that regulatory affairs and compliance were not only documents, but there was something more, and I found my values inside that,” Testa said of the field that requires legal, technical, interpersonal, and soft skills. In 2021, her successful consultancy was acquired by CompLife Group, which is headquartered in Milan with facilities in Europe and abroad. The company offers testing services in the cosmetic, medical device, nutraceutical, and pharmaceutical industries, which matched withCompLife’s desire to explore the medical device industry through regulatory affairs consultancy.

Testa said the partnership allowed Thema to grow. Thema now has a growing team of 25, supported by CompLife, which employs 250 individuals.

Thema currently handles all of the services connected with compliance – regulatory affairs and quality affairs – for medical device and in vitro diagnostic companies. “We have a global approach, so we can support companies to enter into the markets not only in Europe, but also in the U.S., in Canada, South America, and Australia, and the major countries of this world,” Testa said.

The company’s strategic plan this year is to have two to three people in Philadelphia. Thema will lean on the structure already in place in Europe with CompLife Group, including support from its marketing team, which will help Thema build its brand awareness in the U.S.

“We decided to enter into the market, not with big investments, but step-by-step, and try to understand how things develop in the future,” Testa said. That includes building relationships, becoming a member of the Chamber and Life Sciences PA, and organizing events and webinars. “We will start with Philadelphia because we are located there,” she said. “We will try to make the local market grow and we want to understand if we can contribute. This is our target.”

For information on locating or expanding your business in Greater Philadelphia, contact Lindsey Hover, Manager, Business Attraction & Expansion, at [email protected]. The Chamber’s Select Greater Philadelphia website includes a site selector property-search tool to help you find your office or industrial space. To learn more about B+labs, a life science incubator that offers high-quality innovation, collaboration, and research space, as well as direct access to talent, the region’s cell and gene therapy and health care epicenter, and transit, visit www.brandywinerealty.com/blabs.