The Bigger Picture: Serving life science companies

Most RADAR readers are aware of Emergo by UL’s role in helping life science companies bring medical devices, pharmaceutical combination products and IVD products to market. For years, the work has focused on design history files, regulatory submissions and in-country representation. Long-time subscribers also know that Emergo was acquired by UL Solutions in 2017, which created significant benefits for Emergo’s customer base.

You might ask the fair question, what have been the main benefits?

One of the benefits has been the creative and technical resources to build RAMS, our Regulatory Affairs Management Suite that helps our customers understand and manage the ever-evolving landscape of medical device regulations, compliance and representation. Today, more than 17,000 companies rely on RAMS as a pivotal tool that enables companies to negotiate the twists and turns of selling products worldwide. 

And, there are many more potential benefits for life science companies now that Emergo by UL is part of the broader UL Solutions life sciences business. We’ll summarize them below not for self-promotion’s sake per se, but to let you know where you can turn for support, as needed. 

• Human factors – Our top-notch Human Factors team has helped customers bring literally hundreds of new products to global markets, meeting local regulatory requirements and global standards for human factors. Frequently sought services include early user research, use-related risk analysis, user interface design, usability testing and human factors report preparation. The Human Factors team helps support the development of new products that are safe, effective and satisfying to use. 

• Supply chain – UL Solutions is at the forefront of advising companies regarding material sources in terms of ethical sourcing, material properties and safe handling. In doing so, our Supply Chain Insights team leverages several proprietary software programs that have set an industry standard for completeness and trustworthiness.  

• Sustainability – UL Solutions is also at the forefront of helping companies meet their sustainability commitments, reflected in corporate policies and public messaging. Specifically, UL Solutions helps product developers choose materials, implement manufacturing processes and produce products that are less energy intensive, thereby reducing carbon emissions. 

• Workforce training – For years, the UL Solutions workforce training platform (ComplianceWire®) has been the gold standard in the pharmaceutical, medical device and biologics industries, helping life sciences companies meet government requirements pertaining to document workforce qualification and training (e.g., the US Food and Drug Administration’s CFR 21 Part 11). We have vast experience creating or updating workforce training content that is central to ensuring manufacturing quality and successful audits by governments 

• Safety – The world knows the UL Mark, which for over a century has enabled customers to demonstrate that their products meet applicable safety standards, such as IEC 60601 and IEC 61010, which pertain to electrical safety and much more. Over 100,000 products carry the UL Mark, supporting certification that they meet or exceed standards pertaining to safety and performance of essential functions. Our team also provides custom test reports to support your regulatory submissions. Whether it’s a National Technical Reports Library (NRTL) Mark that you need or an Informative Test Report for inclusion in your Technical File, we can help. 

• Engineering – Decades of product inspection, testing and certification work at UL Solutions has created a tremendous base of engineering know-how that we put to work daily for customers. You can turn to UL Solutions for expert guidance on a tremendous range of topics that may be central to producing a successful product. Here is a small sample of topics on which UL can provide critical guidance: plastics outgassing, lithium-ion battery thermal protection, biocompatibility, electromagnetic insulation and interoperability.  

• Software – Germany-based Method Park was acquired by UL Solutions in 2021 and brought with it extensive expertise in medical device software engineering. Following its highly regarded Stages process, Method Park develops both front- and back-end software for a wide spectrum of medical products serving life-critical purposes. 

Here are some examples of how Emergo by UL and UL Solutions have helped product developers. 

1. Conducted a 90-participant usability test, as required by IEC 62366 and FDA’s guidance to industry, to validate that insulin pen injectors could be used safely and effectively by the astounding number of people worldwide who have diabetes and self-administer their medication. 

2. Supported a medical device manufacturer in entering multiple emerging markets to achieve their global revenue and sales growth targets. On a related note, RAMS SmartBuilder facilitated the compilation of the customer’s regulatory submissions, fostered team collaboration and decreased submission times. The manufacturer has now successfully earned FDA 510(k) clearance; obtained Notified Body-issued CE marking to the EU Medical Devices Regulation (TDF, CEP, and CER); and obtained Registro approval from ANVISA in Brazil. 

3. Broadcasted to hundreds of ComplianceWire software solution customers – mostly working in the life sciences industry – a live discussion of best practices regarding online learning, methods for verifying on-the-job training and establishing compliance with product manufacturing regulations. 

4. For one of the world’s top-ten medical technology developers, implemented UL Solutions Stages software solution. The software solution will help the customer structure and monitor their product design processes, as well as help them maintain compliance to IEC 62304, ISO 14971 and ISO 13485. 

5. Regularly supports manufacturers with expertise and testing to 80+ standards within the IEC 60601 series of requirements, in addition to Laboratory, Nurse Call and Personal Hygiene standards. In addition to Electrical Safety, we have established centers of excellence for EMC/Wireless, global support with country- and market-specific wireless submission, biocompatibility and other standards. 

6. To support manufacturers of connected medical devices and technologies, established the UL CAP medical device cybersecurity certification program to help manage and mitigate evolving cybersecurity risks and vulnerabilities.   

So, now you know more about Emergo by UL and how our services fit in with the rest of UL Solutions. We are part of an accomplished organization of life science industry experts who can help you produce excellent, safe products while reducing your business risk.  

Michael Wiklund is Leader, Life Sciences Industry Practice at UL Solutions.