AKRON—With the planned 2021 opening of a new, 1,200-sq.-ft. medical device functional testing laboratory in Northeast Ohio, Smithers will become one of the first independent testing and consulting firms to offer both analytical chemistry and functional medical device testing in both North America and Europe.
The new lab, to be operational by the first quarter of 2021, will be part of more than 4,000 square feet of medical device lab testing space in North America, and will complement additional, similar testing facilities in Leatherhead and Shawbury, England. The lab will be built adjacent to the company's analytical chemistry testing lab at Smithers' Akron headquarters, built in 2017.
"Smithers has been a partner to the life sciences industry for many years, and we are constantly seeking feedback from our clients regarding their testing and validation needs," said Gael Peron, vice president of medical device testing at Smithers. "Our North American clients have asked for a functional and mechanical device testing laboratory in the United States with the same capabilities and expertise as our established lab in the United Kingdom. This expansion of our global portfolio will result in faster turnaround times and more efficient product development processes for our clients here in North America."
The capital investment for the lab was not disclosed by the privately owned Smithers.
Peron said Smithers has hired a lead engineer for the new Akron lab and is recruiting four additional people for positions there. More positions could be added in the future, he said, and the lab has room to expand on site. Smithers has 800 employees globally, with more than 50 focused on the life sciences market.
The device testing lab—which focuses on ensuring that a medical device functions properly by evaluating the performance properties of its components—is intended to fill a portfolio gap for Smithers, especially for North American customers, Peron said.
Smithers, which also maintains North American (Lansing, Mich.), European and Asian laboratories that conduct materials, packaging and distribution testing, began aggressively pursuing testing capabilities in the life sciences several years ago. Its analytical chemistry testing lab in Akron came first, offering evaluations for the chemical interactions between the medical device's construction materials and the drug substance itself within the device.
The two types of labs, along with Smithers' capabilities in distribution and testing of packaging materials (medical or otherwise), complete a unique "one-stop shopping" experience for Smithers' customers.
"The analytical chemistry lab and the functional testing lab both help companies bring great medical products to market," Peron said. "These laboratories are part of a suite of service offerings that allow Smithers to help our clients understand their products from concept through design, prototype, regulatory approval, batch release and delivery."
Functional vs. analytical testing
As mentioned, functional device testing measures performance indicators of a device, such as those of an epinephrine injector or asthma inhaler.