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2023 Regulatory performance report
Today at Rimsys, we unveiled the 2023 MedTech Regulatory Performance Report, a new set of insights into the state of medtech regulatory affairs. Compiled based on interviews with 200 regulatory professionals and executives, the study provides a detailed look into how regulatory teams are staffed, their processes, the tools they use, and ultimately how they perform.
Why did we create this study? There were two driving factors behind the research. The first was a common theme that we heard from a number of our customers: Regulatory leaders don’t have clear data and benchmarks. They don’t necessarily know how long a new market submission should take, and how to plan for or assess the work of their teams. While other studies look at the medtech industry broadly or the state of the regulatory profession, this study tries to build a comprehensive resource for regulatory (and company) leaders.
The second factor was really for ourselves and the team at Rimsys. As a company building solutions specifically for medtech regulatory affairs, we wanted more insight into where companies were successful, where they struggled, and where we can add value.
What did we find? Regulatory teams perform a lot of hero work and rate themselves highly for their accomplishments. At the same time there is a lot of opportunity for process improvements, and companies that invest in digital transformation for regulatory affairs see better performance.
Regulatory professionals are superheroes
Regulatory teams are generally pretty small. Most companies have less than 10 full-time regulatory professionals. These small teams complete an enormous amount of work. Last year on average, RA teams completed 50 license renewals, 50 license updates, and 10 new market submissions. This is impressive output.
Digging a bit under the covers, we found that this output relied heavily on the support of external consultants. 90% of companies use consultants to keep pace with their regulatory workload. Front-line employees also struggle with burnout. They were much more likely to report feeling under-resourced than regulatory leaders.
But process problems persist
A lot of regulatory work remains extremely manual. 70% of regulatory teams spend half their time or more on repetitive administrative tasks. All of this manual work increases the frequency of errors and required rework. 61% of companies reported a major non-compliance incident in the past 2 years.
Manual work also makes it difficult to complete regulatory projects in a timely fashion. Teams completed a lot of projects, but each took a long time. Over half of all companies spend 4 months or more on license renewals, license updates, and new market submissions.
Moving regulatory affairs forward
As regulatory requirements become more complex, there’s a natural question about how teams will work moving forward. MDR & IVDR in Europe have significantly increased the regulatory workload required to bring and keep products on the market. Will organizations be able to keep pace with the same resources, tools, and processes?
No, and the performance report shows that medtech companies are investing to improve their regulatory capabilities. The majority of companies are planning to increase the sizes of their RA teams in 2023, and 40% expect to increase their investments in regulatory software. Companies are increasingly adopting specialized software to better support regulatory processes.
Dig into the survey results
The full survey results provide insights into more aspects of regulatory performance. They show that companies need to take a deeper look into their processes and how regulatory resources are allocated. There are two ways to learn more:
- Visit the survey page to see the full results (the survey whitepaper can be downloaded at no cost)
- Watch the recording of our webinar with PA Consulting. We discuss the survey results in more detail and share our regulatory predictions for 2023
Post-market surveillance for medical devices in the European Union
This article is an excerpt from Post-market surveillance for medical device in the European Union.
Table of Contents
- What is post-market surveillance?
- What classes of medical devices require post-market surveillance?
- Components of a successful post-market surveillance plan
- PMS data requirements
- Post-market surveillance system goals
- Required post-market surveillance reporting
- Embracing post-market surveillance as an integral part of your quality program
- Getting started with post-market surveillance
Post-market surveillance (PMS) is designed to monitor the performance of a marketed medical device by collecting and analyzing field use data. Article 10 of the EU MDR and IVDR requires all device manufacturers to have a post-market surveillance system in place. The main elements of the PMS are laid out in Article 83, and additional details for lower-risk and higher-risk devices are covered in articles 84 and85, respectively.
In general, a PMS system consists of both proactive activities and reactive, or vigilance, activities. While post-market surveillance and vigilance are sometimes used interchangeably, vigilance consists of separate activities that feed post-market surveillance programs.
Post-market surveillance systems are used to collect and analyze data not only about the manufacturer’s device but also about related competitors’ devices that are on the market. Data collected through PMS procedures is then used to identify trends that may lead to, among other things, quality improvements, updates to user training and instructions for use, and identification of manufacturing issues.
Note that “market surveillance” encompasses activities performed by a Competent Authority to verify MDR compliance, and should not be confused with the topic of this ebook,“post-market surveillance," which is performed by the manufacturer.
All medical devices marketed in the EU require some level of post-market surveillance, and all medical device manufacturers must implement a post-market surveillance system (PMS). The requirements of the PMS, however, vary and should be “proportionate to the risk class and appropriate for the type of device” (MDR Chapter VII). In particular, the type and frequency of reporting vary based on a device’s risk class.
A post-market surveillance plan (PMS) is an integral part of a manufacturer’s quality management system and provides a system for compiling and analyzing data that is relevant to product quality, performance, and safety throughout the entire lifetime of a device. The PMS should also provide methods for determining the need for and implementing any preventative and corrective actions. A PMS system should include and define:
Surveillance data sources
With the increased focus on proactive risk identification in the MDR, it is important to design post-market surveillance systems that actively acquire knowledge and detect potential risks. It is not sufficient to rely solely on spontaneous reporting by healthcare providers, patients, and other stakeholders.
In addition to information coming from Clinical Evaluation Reports and complaint and adverse event reporting, typical sources of surveillance data include:
• Social media networks: Because many of your stakeholders may be communicating on social media networks, it is important to employ social listening techniques and/or tools to identify issues and concerning trends as they develop.
• Industry and academic literature: Any studies, academic papers, and other literature that addresses similar devices or the specific use cases for which your device is designed should be evaluated. In particular, risk factors and adverse events identified with similar devices should be closely examined. It is also important to identify newer technologies that may affect the benefit-risk ratio and establish a new definition of “state of the art” for the device type.
• EUDAMED: While the European Database on Medical Devices (EUDAMED) is not yet fully functional, it is intended to provide a living picture of the lifecycle of all medical devices marketed in the EU. Manufacturers should take special care to consider information for similar devices made available through the EUDAMED system in the future.
• Registries: Patient, disease, and device registries can provide information that informs the clinical evaluation process which provides input into the post-market surveillance system.
Data analysis methodology
A well-defined data analysis methodology will accurately identify trends and lead to defendable decisions in the application of post-market experience. Once the necessary information has been identified and collected, and potentially cleaned of incomplete or otherwise unusable data, the data needs to be analyzed.
The goal is to identify meaningful trends, correlations, variations, and patterns that can lead to improvements in the safety and efficacy of the device. There are many data analysis tools available that can assist with:
• Regression analysis that will identify correlations between data (e.g. the device location/geography correlates to battery life).
• Data visualization that can be useful in spotting trends in the data.
• Predictive analytics, which can be particularly useful with large data sets, to identify future trends based on historical data.
• Data mining, which is also normally used with large datasets, to organize data and identify data groups for further analysis.
Benefit-risk indicators and thresholds
The MDR requires that medical device manufacturers not only demonstrate the clinical benefit of their device but also quantify the benefit-risk ratio. The benefit of a device must be shown to clearly outweigh the risk for it to gain market approval. Article 2 (24) of the MDR defines the benefit-risk determination as “the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose when used in accordance with the intended purpose given by the manufacturer.”
A PMS system should clearly define benefit-risk calculations and the data used to support them. Post-market surveillance activities are critical in order to re-evaluate and maintain the benefit-risk calculations and determinations of a device throughout its life. Information that is gained through a PMS system can lead to:
• Identification of new risk factors.
• Adjustments to risk frequency and/or severity values based on actual use data.
• Adjustments to established risk calculations based on new “state of the art” technologies becoming available.
• Adjustments to established benefit calculations based on actual use data.
While complaint handling and other feedback tracking are more often described as part of post-market vigilance systems, they play a role in the more proactive post-market surveillance processes as well. A PMS system should define ...
To continue reading this ebook, download the full version.
Arena Solutions and Rimsys announce partnership to offer an end-to-end quality and product-centric regulatory solution
Foster City, Calif., January 12, 2021 – Arena Solutions, a leader providing cloud-based product development solutions for high tech, consumer electronics, and medical device industries, today announced a new partnership with Rimsys Inc., a world-leading provider of a holistic Regulatory Information Management (RIM) software platform designed specifically for medical technology (medtech) companies.
The Arena and Rimsys partnership offers a secure cloud-based, product-centric regulatory solution for the medtech industry. Rimsys seamlessly integrates with Arena’s QMS and PLM solutions by pulling product and documentation information directly into Rimsys to create, manage, and maintain marketing applications such as 510(k), Summary Technical Documentation (STED), and Table of Contents (ToCs).
The Arena product development platform connects product and quality processes allowing dispersed teams throughout the product design and manufacturing process to work together. Rimsys integrates with Arena’s platform by syncing product information so companies can better manage global registrations and selling status at the SKU level. Rimsys has the capability to pull in QMS records and documentation to create and compile regulatory applications from approved documentation. The integration automatically monitors for documentation changes and alerts users when updates occur with additional reporting based on document location ensuring a single and accurate source of truth.
"The seamless and deep integration between Rimsys and Arena solutions reduces the day-to-day regulatory management," said James Gianoutsos, Founder and President of Rimsys. "The administrative burden of compiling marketing applications and the maintenance of product data is completely eliminated, allowing for increased compliance, efficiency, and visibility throughout the organization."
"Our partnership with Rimsys makes it easier for MedTech companies to address regulatory affairs, product registration, and standards management more effectively," said George Lewis, VP of Business Development and Strategy for Arena Solutions. "This new integration streamlines regulatory compliance processes by accelerating the notification of updates to critical quality records and documents."
About Arena Solutions
Arena Solutions helps innovative electronic high tech and medical device companies create products that change the world. Arena unifies product lifecycle (PLM) and quality management (QMS) processes, allowing every participant throughout the product realization process from design to manufacturing to work together. With Arena, teams accelerate product development and delivery to increase profits. For more information, visit ArenaSolutions.com.
About Rimsys
Rimsys is a world-leading provider of Regulatory Information Management (RIM) software for medical technology companies. Built by and for regulatory affairs professionals, Rimsys digitizes, automates, and creates regulatory order to ensure products adhere to changing global regulations. It is the only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software that makes it easy to manage global UDI requirements and navigate the pillars of regulatory affairs, including product registration, standards management, essential principles/GSPR, and regulatory intelligence. rimsys.io
Rimsys releases new automated unique device identification (UDI) module for its holistic medtech RIM platform
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced the release of an innovative and automated solution to address the global Unique Device Identification (UDI) requirements. This enhancement to the Rimsys ecosystem is immediately available to new and existing customers, providing a compliant method for tracking and traceability of UDI data that is fully compatible with global health authority databases.
UDI is a global harmonization effort to provide more consistent data that benefits overall product traceability throughout the medical device supply chain. It aims to adequately identify medical devices from manufacturing through distribution to patient use. Because global markets have different UDI requirements, product data can become a maintenance nightmare, even for the most mature medical technology companies. Data management is further complicated as UDI data is not static and must be updated based on changing regulatory requirements, such as market dates and registration status.
"Rimsys is the first automated UDI solution to fully integrate into a product’s registration lifecycle, ensuring that changing regulatory information is properly captured, registered, and maintained with the product and within government UDI databases like the GUDID (USA) and EUDAMED (EU)," said James Gianoutsos, Founder & President at Rimsys, "The current solutions landscape revolves around creating in-house, custom, and expensive projects with custom-built software or existing ERP software that were not designed to keep up with the fast-paced and ever-changing regulatory landscape."
In order to stay compliant and competitive, medical technology companies need to adapt quickly and flawlessly to the regulatory environment. As UDI requirements are rolled out across the globe, Rimsys’ UDI module seamlessly integrates with product registration data that is already actively managed within Rimsys, resulting in less maintenance, reduced costs, better compliance, and ultimately decreased time-to-market.
"We have already seen how our system has helped world-leading medical technology companies, such as Johnson & Johnson, Omron, and Terumo, digitize, automate, and navigate the global regulatory landscape,” said Brad Ryba, Chief Technology Officer at Rimsys, "As these requirements and demands continue to evolve, we are committed to ensuring that regulatory professionals can leverage the data integrations within Rimsys to more proactively manage their regulatory information."
Interested customers can schedule a preview of the new UDI module.
Rimsys named 2020 top technology company finalist by Tech 50 awards
Rimsys has been named a Finalist in Tech 50’s 2020 awards program hosted by the Pittsburgh Technology Council. The awards program, which was held November 12, 2020 at a virtual gala event, announced the winners and finalists. Rimsys was nominated as Innovator of the Year in the MedTech category, along with Sentact, Philips, and TeleTracking Technologies. In addition to the Company’s nomination, Rimsys’ Founder and CEO, James Gianoutsos, was nominated for CEO of the Year.
The awards program honors technology innovation in the region. Rimsys Inc., provider of the only holistic Regulatory Information Management (RIM) software for medtech is headquartered in Pittsburgh, Pennsylvania and was proud to be among the 2020 nominees. Rimsys was named a finalist this year, as Sentact, a provider of healthcare technology solutions for the patient care journey, walked away as the winner. Barbara VanKirk, CEO of IQ Inc., won this year’s CEO of the Year award.
"Rimsys is honored to be a finalist in both categories. Thank you to the Pittsburgh Technology Council for highlighting all of these innovative companies, and congratulations to this year’s winners," said Gianoutsos, "Rimsys is already used and trusted by leading companies, including Johnson & Johnson and Terumo, and we look forward to the near future where Rimsys’ automation of the global regulatory landscape is commonplace for medical technology companies and regulatory affairs professionals."
James Gianoutsos founded Rimsys in 2017, recognizing that while regulatory management platforms existed for pharmaceutical companies, medical technology companies face an entirely different set of challenges and requirements. Equipped with the expertise and drive to give regulatory affairs professionals a better way, he developed Rimsys: a RIM software built 100% for medtech companies.
Rimsys consolidates all the major functions of regulatory affairs on a 100% secure, cloud-based software, making product registration, standards management, essential principles/GSPR, and regulatory intelligence easy. Its newest integrated module manages global UDI requirements.
"It’s been an unparalleled year with unthinkable challenges," said Audrey Russo, President & CEO of the Pittsburgh Technology Council, "The COVID-19 Pandemic has tested everyone’s mettle in ways never imagined. This year’s Tech 50 is a testament to the fortitude, creativity, and innovation that exists across our industry, membership, and in every Tech 50 winner and finalist."
For a full list of finalists and winners, visit the Pittsburgh Technology Council’s website.
Rimsys secures $1.5 million to accelerate growth of its leading medtech regulatory information management platform
Rimsys Inc., provider of the leading Regulatory Information Management (“RIM”) software designed specifically for medical technology (“medtech”) companies, announced today it closed a $1.5 million investment round, led by Allos Ventures. The financing round will support Rimsys’ penetration of the medtech RIM market through planned expansions of its product offering, sales, and marketing execution. Rimsys serves an expanding list of enterprise customers, including industry leaders such as Johnson & Johnson and Terumo.
"Complex regulatory challenges create barriers that delay product time-to-market, stall revenue growth and increase exposure to compliance risks for even the most experienced medtech companies," said James Gianoutsos, founder & president of Rimsys. "Regulatory teams are in need of digital solutions that provide more efficient and compliant ways to stay on top of a constantly changing regulatory environment"
Rimsys’ solution seamlessly integrates with medtech manufacturers’ existing quality management systems, product lifecycle management systems, and sales and distribution software systems. Rimsys’ robust digital platform, with its intuitive user interface and global intelligence, enables its customers to meet market entrance requirements and grow internationally. John McIlwraith, managing director at Allos Ventures will join Rimsys’ board of directors.
"The maze of global regulations covering medical technology is growing more complex and frequently results in dead ends and delays that can greatly impact commercialization of these products," said McIlwraith. "This financing round will enable the company to further accelerate its momentum with large enterprise customers."
For more information on Rimsys, please visit www.rimsys.io.
Rimsys announces new brand identity for world-leading regulatory information management (RIM) software
Rimsys, a world-leading Regulatory Information Management (RIM) software platform for medical technology companies, announced a new brand identity and tagline. Rimsys, the only holistic RIM software on the market designed specifically for medical technology companies, with functionality for the pillars of regulatory affairs, rebranded to accurately reflect its novel and advanced offering through a distinct, modern brand identity and messaging platform.
The new visual identity, including logo, color palette, graphic elements, and iconography mirror the trusted, relatable, and modern personality of Rimsys. The colors, which feature a vibrant purple and dark blue, were strategically chosen to differentiate Rimsys from other RIM solutions on the market. The visuals are accompanied by a new mission statement, “to digitize, automate, and create regulatory order for the medical technology industry,” and messaging platform that conveys its value propositions:
- Used and trusted by the world’s leading medtech companies
- Built by and for regulatory affairs professionals in medtech
- Easy to start and simple to scale as your company grows
"We’re pleased to announce this rebrand to our customers and partners, with complete confidence that the new identity and messaging accurately reflect our enterprise software solution," said James Gianoutsos, Founder & President at Rimsys.
Rimsys consolidates all the major functions of regulatory affairs on a 100% secure, cloud-based software, making product registration, standards management, essential principles/GSPR, and regulatory intelligence easy. These functions, plus soon-to-be-released features, were formally messaged in the rebrand, including superior server security, system compliance, and simple integrations with many leading enterprise QMS and ERP/PLM software systems.
"With successful implementations in some of the world’s leading medical technology companies including Johnson & Johnson and Terumo, we already know Rimsys has the power to modernize medtech companies of all sizes and scales," said Gianoutsos. "And now, with a brand that mirrors our capabilities, we’re even better poised to reach out and help more."
Components of the rebrand can be seen on rimsys.io, and the full rebrand will be revealed on a new website that is currently under development.
Announcing the release of Rimsys 3.0: Rimsys Insight
Rimsys Regulatory Management Software, the leading and only Regulatory Information Management (RIM) system platform designed specifically for the medtech industry, has just released Rimsys 3.0, which includes its much anticipated regulatory intelligence module, Rimsys Insight.
Rimsys 3.0 now offers curated regulatory news along with changes to laws, regulations, and guidances that are timely and linked to customers’ specific products, markets and the other customizable filters available to each company. Additionally, the integration of market entrance requirements for the top 50+ global markets, further strengthen the already powerful Rimsys Registrations workflow which manages medical device and IVD registrations at the SKU level.
"Information is meaningless unless you can apply context to it as it relates to your company and products. As regulatory professionals ourselves, we know the specific pain that is experienced by our customers. The user experience should be seamless, fully integrated, and intuitive enough that, regardless of how long that person has been in the industry"
Rimsys was built for and by regulatory affairs professionals, enabling teams to digitize and automate otherwise disjointed, paper-based and manual processes. Rimsys has spent the last year working with customers from some of the world’s leading medical device manufacturers to develop the requirements that seamlessly integrate their business processes with its existing ecosystem of cloud-based regulatory affairs software solutions. This includes global product registrations, submissions management, standards management, essential principles and more.
"There’s simply no other holistic and vertically integrated solution quite like Rimsys out in the marketplace. Our initial features were focused on bringing MedTech companies together to collaborate and connect with each other internally. Built on this solid foundation, our latest release truly empowers and connects them to the entire global regulatory ecosystem"
Rimsys is a holistic approach to modernizing, digitizing and automating regulatory affairs activities for the MedTech industry by providing a single source of truth. Rimsys is now aligned and positioned to continue its growth and mission to "digitize, automate and createregulatory order for the medical technology industry™."
