Emergo by UL: Five Core Business Segments Accelerate Medical Device Market Entry and Set Benchmark for Global CRO Excellence

The COVID-19 pandemic has driven strong demand for nucleic acid testing kits, with numerous medical device and in vitro diagnostics (IVD) companies striving to bring their products to market as quickly as possible while ensuring safety and efficacy. A typical representative in this regard is Hybribio, a leading enterprise in China’s nucleic acid molecular diagnostics sector.

During the application for EU certification of the 2019-nCoV nucleic acid detection kit, Hybribio and the Emergo by UL (hereinafter referred to as “Emergo”) team jointly prepared materials and responded rapidly, collaborating concurrently with Emergo’s expert teams in the Netherlands, Japan, and the United States across three time zones. Under Emergo’s remote guidance and technical support, both parties completed the preparation of all technical documentation for CE certification and submitted the application within just four days, thereby establishing a fast-track pathway for COVID-19 nucleic acid detection reagents to support global epidemic prevention and control efforts.

As a supporting partner, how does Emergo leverage its professional expertise to deliver rapid-response global services? To address this question, VCBeat has reviewed Emergo’s development history, team background, and core business operations.

Emergo by UL was formerly known as Emergo Group.

Emergo Group was founded in 1997 by René Van De Zande. Headquartered in Austin, Texas, in the southern United States, the company was established to help U.S. medical device companies export their products to Europe. Under René’s leadership, Emergo has grown into the world’s largest medical technology regulatory affairs firm, with offices in 25 countries worldwide, offering a comprehensive range of compliance and market access services.

In April 2017, UL, a company primarily engaged in safety standards testing, announced the acquisition of Emergo, and Emergo Group was officially renamed Emergo by UL.

UL acquired Wiklund Research & Design in 2012. Over the following six years, its consulting business grew by more than 400%, reflecting strong demand in the market for regulatory compliance consulting services.

René van de Zande, President and Chief Executive Officer of Emergo, pointed out: “Many small and medium-sized manufacturers worldwide simply lack the resources and expertise to navigate complex regulatory issues.”

“UL and Emergo share a common goal of positively impacting medical device compliance and safety,” said Upayan Sengupta, Global Vice President and General Manager of UL’s Health Sciences division. “This acquisition enables UL to provide value-added services to medical device manufacturers as they enter emerging markets.”

The integration of UL and Emergo’s services will also help medical device manufacturers significantly improve efficiency, broaden global market access channels, and accelerate time-to-market for their products. UL plans to retain Emergo’s Austin headquarters and its global offices. Emergo’s President and CEO, René Van De Zande, along with more than 200 employees, will continue to serve within the company.

Today, Emergo by UL is a global compliance consulting firm specializing in the overseas regulatory requirements for medical devices and in vitro diagnostic (IVD) products. With operations spanning more than 20 countries and regions across Asia, the Americas, and Europe, it has provided one-stop market access solutions to over 1,000 medical device and IVD companies worldwide. These services include product registration, local representation, human factors engineering and usability study design, and cybersecurity for digital health technologies.

In addition, they assist companies with global regulatory strategy, device registration, quality management system compliance, clinical trial consulting, domestic regulatory representation, and distributor qualifications. Emergo’s senior regulatory technical team boasts an average of over 10 years of experience in medical device research and compliance. Actively engaged in standard committees both domestically and internationally, the team effectively provides professional and actionable strategic advice for market expansion overseas to medical device and IVD enterprises.

Emergo’s founder, René Van De Zande, holds master’s degrees from Radboud University Nijmegen and Johns Hopkins University. For 20 years, from 1997 to 2017, he served as Chairman and Chief Executive Officer of Emergo.

In April 2017, after Emergo was acquired by UL, he served as a Director and General Manager. At the end of 2019, René resigned from all his positions at Emergo to shift his professional focus to other areas. Currently, he is the head of Zeeland Ventures, a venture capital firm that specializes in facilitating management buyouts and mergers and acquisitions.

Following René’s departure, Michael Van Der Woude assumed the role of General Manager. Mr. Van Der Woude holds a master’s degree from the University of Groningen and possesses extensive experience in financial services and management. Prior to the acquisition of Emergo by UL, he served as Chief Operating Officer (COO) of Emergo. Currently, in addition to his duties as General Manager, he also serves as Director of Operations.

Jaap Laufer is the current Vice President of Emergo. He also graduated from the University of Groningen with a Ph.D. in Pharmacology. He joined Emergo in 2005 and has over 30 years of experience in medical device regulatory affairs to date. He specializes in submissions for implants and high-risk devices, FDA/QSR compliance, as well as the approval and compliance of clinical studies. He is also responsible for Emergo’s regulatory and clinical affairs.

Currently, Emergo’s business is primarily composed of five major segments: Clinical Research (CRO), Market Compliance Consulting, Human Factors Research and Design, Digital Health and Cybersecurity Consulting, and Business Process Services.

(Graphic by VCBeat)

CRO is a critical step to ensure product safety and efficacy, enabling it to achieve its intended use. Emergo’s CRO team specializes in pre-market and post-market clinical studies for medical devices.

Emergo’s CRO expert team has long focused on the medical device sector, boasting decades of extensive experience,Conduct clinical studies for medical devices in compliance with regional regulatory requirements, providing pivotal CRO solutions—from site selection to data analysis—to manage all aspects of post-market clinical studies for medical devices.

Currently, Emergo's CRO business mainly includes the following aspects:

Emergo partners with medical device manufacturers to design CRO solutions for medical devices and manage clinical trials, ensuring their smooth execution. Emergo’s current business footprint spans Israel, India, China, Japan, and Canada, with collaborations established with hundreds of medical device companies worldwide.

Emergo’s CRO management team possesses extensive experience in the medical device sector, having managed numerous projects involving high-risk cardiovascular, orthopedic, and combination products. Emergo’s ultimate objective is to shorten clients’ trial timelines while minimizing costs to deliver positive outcomes.

Medical Device CRO Review is an independent audit of clinical trial data and results, aimed at ensuring that data collection, analysis, and reporting are conducted in accordance with the study protocol, Good Clinical Practice (GCP), and applicable regulatory requirements.

Emergo’s specialized teams in the medical device clinical field across Europe, Japan, China, India, and the United States can perform services such as SOP audits, database audits, and process audits to ensure that trial results comply with all requirements outlined in the clinical study protocol.

Nowadays, regulations for medical devices are continuously updated, making it essential to maintain compliance through post-market clinical follow-up studies. Furthermore, medical device manufacturers increasingly need to conduct post-market clinical follow-up studies to gather more data on product sales performance.

Emergo’s post-market clinical follow-up services for medical devices feature local consulting teams in the United States, Europe, and other regions, assisting companies with various regulatory compliance matters, including planning, assessment, and market research.

Regulatory authorities in most medical device markets require registrants to fulfill post-market surveillance (PMS) obligations to maintain compliance. However, PMS regulations may vary across different markets and regions, necessitating that manufacturers develop tailored market compliance strategies.

Leveraging its expertise in post-market surveillance requirements, Emergo can serve as a long-term compliance advisor for medical device companies after market launch, helping them design and implement PMS systems that meet the regulatory requirements of different markets.

For market compliance consulting on medical devices, Emergo has also developed an app—RAMS.

The RAMS software platform was developed by Emergo regulatory experts,Designed to help medical device companies stay abreast of the latest global regulatory developments, and to prepare application documentation for FDA 510(k) submissions, coordinate registration and updates, and facilitate the review process.

RAMS Key Features

(Image source: Emergo official website)

Ludwig Herrmann, Regulatory Manager at MAVIG, wrote in his evaluation of RAMS: “With RAMS, our small team can now easily manage a large volume of registration information and related licensing certificates, allowing us to focus on bringing new products to market.”

Human Factors Engineering is a vital engineering discipline that studies the interaction and optimal integration between humans, machines, and environments. It aims to design machine and environmental systems that align with human physiological and psychological characteristics, thereby enhancing efficiency, safety, health, and comfort in production.

When the company was still known as Emergo Group, it already had a team dedicated to research-related services. After rebranding as Emergo by UL, its Human Factors Research & Design (HFR&D) division has built an even more specialized team to help clients bring products to market and ensure optimal user experiences.

Adhering to the design philosophy of “adapting products to meet user needs and preferences while providing intuitive solutions,” Emergo offers the following services in its Human Factors Research and Design division: human factors user research for medical device and IVD companies, human factors analysis for medical devices, human factors design and prototype development, medical device and product evaluation, and medical device usability training and consulting.

User research can help companies gain a deeper understanding of the factors influencing the quality of user-product interactions. Emergo conducts user research through various methods, including in-context field observations, user diary studies, and telephone interviews, to collect product-related feedback from users. The insights gathered on user needs and preferences are then integrated into user-centered design solutions.

Conducting a comprehensive risk analysis related to product use is central to developing a safe product. Emergo’s human factors experts perform targeted analyses that help companies design products that are safe, effective, and compliant with regulatory requirements for human factors engineering.

Emergo has already conducted services such as risk analysis related to the use of medical products and consumer goods, benchmark usability testing, and interviews with trainers and users in the field of human factors engineering analysis for medical devices.

Users interact with medical devices through their user interfaces, which can range from large systems such as MRI scanners to small components like the displays, controllers, and other touchpoints on blood glucose meters. Regardless of the device type or the scale of its user interface, poor design is a root cause of potential hazards and use errors.

Emergo determines design requirements through extensive user data research and balances functional goals with aesthetic objectives.

Emergo’s services in medical device user interface design include: medical device design and prototyping; label and Instructions for Use (IFU) design and evaluation; and user interface design for medical devices or in vitro diagnostic devices.

During the research and development process, effective design evaluation is central to product design and a prerequisite for ensuring a positive user experience. There are numerous methods for evaluating products; the optimal approach depends on the stage of product development and available resources, such as time, budget, or team capacity.

Emergo’s evaluation methodologies include expert design reviews, heuristic analysis, cognitive walkthroughs through use-case discussions, preliminary usability testing, and validation usability testing. Tailored to different stages of product development, Emergo’s evaluation services also encompass early-stage, mid-stage, late-stage, and post-market assessments.

Medical device companies must integrate human factors engineering activities with risk management processes to ensure compliance with stringent regulatory requirements and standards.

Emergo’s medical device usability training and consulting services are primarily delivered through workshops, regulatory affairs guidance, and competitive gap analyses.

Emergo’s digital health team boasts years of extensive experience in medical devices, cybersecurity, and usability, enabling it to manage connected device systems including Medical Device Data Systems (MDDS), Software as a Medical Device (SaMD), and Internet of Medical Things (IoMT) devices.

The Company’s digital health and cybersecurity consulting services are primarily divided into three segments: cybersecurity regulatory compliance, security in medical device development, and cybersecurity organizational processes.

Cybersecurity regulatory services primarily help medical device companies address issues related to cybersecurity, data privacy, and interoperability risks, ensuring compliance with regulatory requirements.

Emergo asserts that all participants in the medical industry, including hospital administrators, healthcare providers, and medical device developers and manufacturers, bear the responsibility to enhance the security of connected medical devices to address the threat of cyberattacks.

In ensuring the security of patient data, developers and manufacturers must do more than merely meet minimum regulatory requirements. They need to comprehensively assess and address potential cybersecurity risks associated with their products, not only during the product development phase but also throughout the product’s expected service life.

In recent years, regulatory authorities worldwide have begun to establish regulatory requirements for cybersecurity and data privacy to ensure that connected medical devices are not only safe and effective but also capable of effectively managing cybersecurity risks.

Emergo’s services include organizing privacy and security workshops to lay a solid foundation for enterprises; providing gap analysis services to identify non-compliance issues early in the design phase; and offering consulting services to assist enterprises with regulatory submission and ensure compliance with necessary cybersecurity requirements.

Secure Development Lifecycle refers to the practice of simultaneously considering safety risks associated with medical devices throughout their design, development, maintenance, and decommissioning phases, which is the optimal approach to ensuring the safety of medical devices.

Medical device manufacturers need to embed these factors into their research and development processes. Emergo can assist enterprises in managing the safe development lifecycle by reviewing, evaluating, and advising on their products, as well as designing a comprehensive solution.

An enterprise must establish a properly structured hierarchy and management procedures; therefore, it is essential to formulate appropriate regulations within the organization to integrate cybersecurity into the research and development lifecycle of medical devices.

Emergo helps enterprise organizations build cybersecurity capabilities to effectively address regulatory requirements and market challenges by reviewing, assessing, recommending, and developing corporate cybersecurity guidance content focused on topics such as supply chain policies for cybersecurity governance structures, as well as incident management, response, and communication processes.

Through its business process services, leveraging professional expertise, technology, and years of industry insight, Emergo enables clients to operate their companies efficiently without sacrificing opportunities. This allows clients to focus on their core competencies—such as the design, commercialization, or procurement of medical devices—while accurately anticipating and rapidly responding to their regulatory needs.

Emergo’s business process services primarily focus on the following areas:

Medical Technology—Build efficient and agile internal operations, enabling enterprises to focus on customers and core competencies while partnering with world-class providers of regulatory, quality, and clinical business process services.

Health Tech—Help clients build scalable RA/QA core capabilities by leveraging external business process services, which will design, implement, and operate essential RA/QA processes critical to the healthy functioning of client companies.

Incubators and Accelerators—Shared services designed for incubators and the startups they serve provide a more effective way to help early-stage companies gain access to world-class RA/QA capabilities.

Health and Wellness Retail—Managing compliance, quality, and safety risks requires specialized expertise. Emergo establishes dedicated business teams to focus on emerging healthcare ventures and leverages third-party service providers with extensive experience in this field.

Emergo Business Process Service Content

(Image source: Emergo official website)

According to Emergo’s official website, Emergo has an office in Guangzhou, China, and primarily provides market compliance consulting services across China.

In the global fight against COVID-19, Mr. Gu Guiguo, General Manager of Emergo by UL Asia Pacific, stated: “Emergo is always ready to support pandemic control efforts. Although the current global situation remains challenging, many companies both in China and abroad have stepped forward courageously. Leveraging its global expert resources, Emergo by UL is committed to providing comprehensive support and standing alongside these frontline responders by delivering fast, professional, one-stop market access solutions, thereby ensuring the safety, efficacy, and timely availability of their products.”