Company Snapshot
Hologic is a medical device manufacturer specializing in innovative technology for detecting, diagnosing, and treating women’s health conditions. Founded in 1985, Hologic has long been trusted by healthcare professionals to treat their patients with precision, certainty, and confidence. The company’s commitment to sustainability runs deep, with comprehensive initiatives related to environmental performance, serving the global community, and responsible sourcing throughout its entire supply chain. For example, during the COVID-19 pandemic, Hologic was on the forefront of developing and supplying diagnostic testing equipment.
Meeting the PFAS Challenge Head On
The unprecedented rate of new restrictions and regulations on per- and polyfluoroalkyl substances (PFAS) has made the use of this family of chemicals a make-or-break issue for manufacturers. But it’s not just about new reporting requirements — thanks to increased legal liability, chemical companies like 3M are pulling out of PFAS manufacturing, triggering major supply chain disruption risks.
For Hologic, the current regulatory environment made PFAS a top priority. The company’s Senior Manager of Chemical Compliance, Joe Langton, describes it as a perfect storm of risks: “Everything PFAS came out all at once… the EPA announcement [on TSCA PFAS reporting], PFAS restrictions in the EU, the 3M announcement about discontinuing PFAS, state-level laws in the U.S.”
PFAS are often considered “essential use” for many medical devices, such as implanted devices, catheters, and tubing. For example, PTFE can prevent wear and corrosion while improving flexibility, reducing the risk of medical complications. While these uses are protected under product compliance regulations, Hologic still faced several urgent PFAS risks:
- Identifying which parts and processes contain PFAS, and which uses are covered by essential use exemptions
- Phasing out non-essential PFAS use to keep up with emerging global restrictions and customer demands
- Finding sustainable sources for essential parts containing PFAS that wouldn’t be disrupted by shifting PFAS regulations
- Having defensible data for PFAS reporting requirements and to back up essential use claims
- Identifying which parts or products are impacted by obsolescence risks, should a company stop producing the necessary chemicals or parts due to PFAS restrictions
Choosing a Proactive PFAS Partner
Hologic was already using the Assent supply chain sustainability management solution to streamline product compliance requirements for regulations such as the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation and conflict minerals reporting, so it was a straightforward decision to implement Assent’s PFAS Identification solution.
Because PFAS requirements are complex and evolving rapidly, Assent’s expert regulatory guidance was also an important deciding factor. “With Assent, I can pick up the phone and talk to someone about how to best respond to a customer, or help me plan for issues I don’t have resources to deal with. It’s not possible to be an expert in every product regulation — but that’s where I can rely on Assent’s team,” Langton explains.
With Assent, Hologic’s compliance team gains the supply chain visibility it needs to pass business intelligence to its executive team for proactive risk management and keep the company ahead of rapidly evolving PFAS requirements.
Guarding Against PFAS Parts Obsolescence
Just because regulators consider a specific PFAS use case to be essential, it doesn’t mean that parts containing PFAS will always be available. Increased scrutiny on PFAS manufacturing has caused a domino effect across global supply chains.
“When 3M announced it would be pulling out of PFAS manufacturing, my phone was ringing off the hook. My executive team needed to know if we’re still going to be able to source the parts we need to build and ship products,” recalls Langton.
Hologic needed to identify all the parts in its supply chain that contain PFAS, giving them strategic insights to assess their parts obsolescence risk. Furthermore, it needed to verify whether anything it sources from 3M contains PFAS, which would indicate a major disruption risk.
Using Assent’s PFAS Identification solution, Hologic was able to automatically survey its suppliers and centralize all submitted PFAS information into digestible dashboards. Hologic identified hundreds of PFAS uses in its operations and then armed its procurement team with actionable data.
“With this knowledge, we’re able to engage our suppliers to understand if they’re reengineering their products or eliminating PFAS from their products. If not, we can then evaluate if we need to find replacement parts or redesign,” explains Langton.
Proactive PFAS Compliance as a Competitive Edge
For Hologic, keeping up with PFAS requirements isn’t just about avoiding disruptions — it’s also good business. Langton says having rapid access to compliance data is a market differentiator that drives sales: “Customers expect you to go beyond the regulatory bare minimum and often add their own custom requirements to contracts. To win, you need to show you can respond to data requests quickly and confidently. Having a program [like Assent] is often the foot in the door you need to make the sale.”
Implementing Assent’s solution has also helped the Hologic chemical compliance team reframe its contributions to the company’s overall performance and bottom line. The compliance team can now more easily communicate data with the engineering and procurement teams, helping inform smarter decision-making in responsible sourcing and product design.
Customers are placing increasing importance on buying from companies with proven sustainability programs, and Hologic has made itself a market leader, using defensible data to grow its business even further. Hologic’s annual sustainability report not only highlights its exceptional internal and external ESG performance — it calls out its supply chain risk management efforts that are fueled by Assent’s platform.
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