Symbiosis at Smithers: Testing firm rounds out services with new lab

With the planned 2021 opening of a new, 1,200-square-foot 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.

"If the device contains a spring, our experts can test to ensure the spring will perform as intended when the device is in use," Peron said. "We can also test for functions such as dose accuracy, ensuring an accurate dose each time it is deployed."

The functional testing lab can glean axial-rotational, tensile testing and other data, including the penetration force and depth of a syringe or needle; forces exerted by springs or other components; the speed and stopping point of plunger movement; volume of drug substance delivery; and more.

Additionally, Smithers can perform endurance testing to determine the lifespan and durability of a product, Peron said.

Customers often bring their devices — from pen, jet and auto injectors to pre-filled syringes, transfusion and IV sets, smart patches and patch pumps and metered dose inhalers — to Smithers seeking each type of testing.

"Many modern drugs come in liquid form and need to be injected into the patient," Peron said. "More and more, devices are being launched to market to help patients administer drugs to themselves without the assistance of a doctor. Smithers conducts physical and analytical testing for many of these devices."

To gather a completely different set of parameters, Smithers' analytical chemistry labs re-create harsh environmental conditions that can accelerate potential reactions between the device and drug product, via extractable and leachable assessments.

These assessments are conducted to identify potential impurities that may migrate into a drug solution from container closure systems, processing equipment or packaging — or the medical device itself.

Extractable studies involve the process of exposing a given material to a variety of environmental conditions to understand what substances can come off the material.

In a leachable study, the drug product is studied for changes in chemical makeup after exposure to the device or packaging materials under specific conditions, he said.

"In both cases, the levels of substances from the studies are then compared with regulatory guidance on maximum allowable limits of these substances," he said. "This is extremely important for the safety of the patient and adherence to regulatory requirements, as this allows us to determine whether any degradations or migrations may occur that could enter into the drug product and cause harm to the patient."

Smithers' on-site, symbiotic capabilities are evidenced by tests on an epinephrine injector, for instance, which is intended to deliver a specific dose of a drug to a patient.

Smithers' analytical chemistry team would assess the materials of construction of the injector to determine any unintended chemical reactions with the drug substance, and the functional testing team then might test the injector to determine whether it functions as intended, Peron said.

A very different example might be a menstrual cup, which makes constant contact with the body while in use, posing its own challenges.

"Our analytical chemistry team could test the cup to determine whether the materials may interact with the body in such a way that leads to chemical compounds being exposed to the user," he said. "This team can also measure whether any elements of the menstrual cup's packaging could impact the properties of the cup and expose the user to unintended substances.

"Our functional testing lab then could test the cup's tensile properties to determine whether the cup could stand up to repeated folding, pulling and other movement and manipulation while in use."

In addition to its analytical chemistry and new functional testing labs, Smithers has years of experience in package and distribution testing for medical packaging.

"We can help ensure that the device will arrive safely at a doctor's office or the patient's home, fully sterile and secure," Peron said of the services offered through its Lansing labs. "We also have nearly a century of experience with polymer material testing and characterization (at the company's analytical chem labs)."

These services can assist developers in choosing the right polymers for construction of their device or delivery system, according to Smithers.

"This complementary in-house testing expertise is unique in the medical device testing industry," Peron said. "Adding the new functional testing lab rounds out our full service offering in North America and expands our total global capacity in combination with our labs located in the U.K."

Smithers earlier this year announced the formation of the Medical Device Testing division, established in response to thriving medical device and combination drug product industries. The new functional medical device testing lab is the first of multiple planned expansions under Peron's leadership, Smithers said.

"The regulatory landscape for medical devices is constantly changing," he said. "Our investments are determined by the needs of our customers. Currently, we are investing tremendously in container closure integrity testing at the request of our customers in both Europe and North America and we will continue to explore other related areas of testing that can create more of a 'one-stop shop' experience."

One might assume that Smithers has been buoyed by the demand created by the coronavirus pandemic, as other companies certainly have, however that would not be entirely accurate.

Smithers early on was deemed an essential business, implementing safety measures to protect its staff and customers.

"We are incredibly proud to be part of this global effort to keep people safe and healthy," Peron said. "But the decision to open the new functional testing laboratory in Akron was made as part of our long-term business strategy and was not informed by the COVID-19 pandemic. Our mission is to help pharmaceutical companies develop and bring great medical products to market. Our investments in this mission are determined by ... how future legislation may affect testing needs.

"Because pharmaceutical and medical device development are highly regulated, both critical activities before and during the pandemic, we continue to see strong demand for testing and verification services."

Outside of the medical space, Smithers, founded in 1925, supports the transportation, packaging, materials, components, consumer and energy industries. The company maintains 14 testing facilities around the world, including facilities in Shanghai and Suzhou, China.