Taking charge of medical device testing

Developing a new medical device is a long road, and regulatory testing is arguably the longest, most difficult stretch. Even the simplest device requires a range of tests, and a more complex, critical one demands testing so extensive as to intimidate even veteran healthcare professionals. The time and money involved are difficult enough, but when multiple labs are required to perform different tests with their own turnaround times, communication styles, and individual quirks, things can really get snarled into a traffic jam.

However, while regulatory testing and compliance are non-negotiable, the process doesn’t have to be so painful. Finnish company Measurlabs coordinates the entire customer-facing side of testing projects, organizing and streamlining numerous services for device developers through one central hub. Leveraging its partnerships with more than 900 accredited laboratories across the world, Measurlabs manages projects for clients in industries ranging from pharmaceuticals to semiconductors, ensuring the work is carried out by the labs best suited to their testing requirements. After a customer submits a request for the tests they need, Measurlabs’ team of chemists and material scientists takes control, assigning the work to the proper labs and overseeing the project until its completion.

“A typical company can use seven different labs, so they’ve set up seven different accounts into their purchasing,” says Teemu Myllymäki, CEO & co-founder of Measurlabs. “They’ve set seven different NDAs [non-disclosure agreements]. They have seven different sample shipping locations where they send samples for testing. They get seven different types of reports and seven different invoices to pay. When they switch to us, we sell the benefit of having only one NDA, one contract, one source of invoices, and all the testing reports look the same. They’re really easy to interpret once you get used to that.”

This well-oiled machine started as a side hobby for Myllymäki and co-founder/COO Kalle Lagerblom when they were Ph.D. students connecting people they knew at a lab with other acquaintances in need of testing services. Word spread until more companies were coming to the pair requesting help, and in 2017, Myllymäki and Lagerblom decided to make a business out of it. Now their customers include approximately 1,000 companies, and in addition to their Helsinki headquarters, they’ve opened a UK location and – as of early 2025 – a U.S. hub in Palo Alto, California.

Easing, simplifying medical device testing

Medical devices comprise one of Measurlabs’ largest business units, but it didn’t start that way – at first, the company didn’t offer much medical testing at all. When the COVID-19 pandemic hit, however, most existing business temporarily halted as customers tried to figure out what was coming next. Then the phone began ringing with customers asking for face mask testing services. While Myllymäki and Lagerblom hadn’t handled this type of request before, they had enough industry knowledge and connections to quickly find the best labs for the job – soon, Measurlabs was the first company in Finland to offer accredited testing services for face masks. Having successfully taken on one Class I medical device, the company decided to expand its services in the industry.

It’s unsurprising medical device testing has grown so quickly for Measurlabs – while testing is a headache in any industry, even a seemingly simple medical device is heavily regulated. Certifying a blood pressure cuff, contacting only intact skin for a limited time, starts with a chemical characterization, followed by a toxicological risk assessment (TRA), cytotoxicity, and skin sensitization and irritation tests. Those are the most common tests for that type of device, according to Elina Tenhunen, technical sales and project manager with Measurlabs. However, depending on the TRA findings, additional tests may be necessary. A more critical device, such as an implant, requires more thorough testing including hemocompatibility, pyrogenicity, and genotoxicity, just for a start.

A single sensitization test, because it’s in vivo, can take up to 11 weeks to complete, Tenhunen says, so planning ahead is vital. The length of turnaround time is one of the top challenges facing medical device manufacturers in testing, along with cost and lack of regulatory understanding. Measurlabs aims to address those roadblocks, starting with discounts it passes along to customers from the bulk pricing many of its partner labs offer.

“Of course, we can’t do much with turnaround time, but we can help plan the testing so it can be optimized as well as it can,” Tenhunen says.

Planning starts with a biological evaluation plan determining which tests are needed and enabling the creation of a test order. This, along with the TRA, allows Measurlabs to cut out any unnecessary tests, reducing delays and needless animal testing – not to mention cost. When a company has several test purchasers working with multiple labs, it’s easy for wires to get crossed, resulting in unneeded or even duplicate tests. By working with a single, centralized partner, Measurlabs’ clients have seen testing cost reductions up to 20%.

Prioritizing continuous learning, growth

Because it has partner labs in Europe and North America, Measurlabs can also help its clients more easily navigate regulatory differences between the European Union’s Medical Device Regulation (MDR) and U.S. Food and Drug Administration (FDA) requirements. The company is diligent about keeping up to date with the rapidly changing regulatory environment and informing others about upcoming changes through its website and newsletter. Often, Myllymäki notes, clients have said Measurlabs was their first source of news about regulatory changes.

Measurlabs aims to capitalize on its forward momentum with further expansion in Europe and the U.S. The company plans to hire additional talent and possibly conduct some small funding rounds to further invest in marketing and technology development. As it grows, Measurlabs also intends to leverage the knowledge it gathers from each test to improve its future services.

“We aim to aggregate most of the world’s testing services on our platform,” Myllymäki says. “By doing that, we benefit customers who develop different types of green technologies, new types of semiconductors, or safer alternatives for materials that release microplastics or PFAS compounds. When people purchase testing services from us, they don’t only invest in getting these tests done, they also invest in getting better services in the future.”

Measurlabs’ plans also include expanding its network of partner laboratories. By strengthening its connections and broadening its reach within the regulatory industry, the company hopes to make simplified, headache-free yet thorough testing available to everyone.

Measurlabs
https://measurlabs.com