Regulatory Strategy as a Competitive Advantage
This article is an excerpt from the Regulatory strategy as a competitive advantage ebook.
Table of Contents
- The regulatory revenue opportunity
- Regulatory responsibilities
- Limitations of the "cost-center" approach to regulatory affairs
- Regulatory as a revenue function
- Competitive advantage #1: Faster time to market
- Competitive advantage #2: Cost avoidance
- Competitive advantage #3: Out-pacing competitors
- Why invest in regulatory/revenue alignment?
- Getting started - 3 steps to move towards a revenue-aligned RA team
It is well known that medical technology (medtech) companies are highly regulated, given the potential risks their products present. Understanding and complying with the complex regulations in each country is, therefore, a necessary part of marketing and selling medical devices. To realize any revenue from a medical device, it must not only demonstrate compliance with all applicable regulations, it must also receive and maintain market clearance from each country in which it is to be sold. No market clearance means no revenue. Given the key role regulatory compliance plays in revenue attainment, regulatory teams, tools, and processes present a significant opportunity for differentiation for organizations willing to invest in them.
For the majority of medtech companies, however, regulatory departments have traditionally been treated as operational cost centers, with departmental improvements focused on cost reduction and efficiency improvements. Limited investment in people and tools, and limited interest in digital transformation, have left regulatory teams across the medtech industry underfunded and under-resourced.
This has led to great resourcefulness within the RA community, where most members can point to heroes within their team who worked long hours to meet a submission deadline, headed off a disaster by uncovering a pending expiration, created ad-hoc systems to organize information and streamline communication between the RA and QA teams for smoother audits, or have otherwise gone above and beyond their typical responsibilities.
Regulatory teams, however, have the potential to be a revenue-driving competitive weapon for companies that are willing to look at them a little differently and invest in regulatory performance above regulatory cost-effectiveness. Well-supported regulatory teams can provide a true competitive advantage by providing the resources and direction to:
- Capture market share by being first to market with novel devices.
- Avoid lost revenue by effectively tracking and planning for registration renewals/updates.
- Out-pace competitors and grow market share by adapting to regulatory changes more quickly and taking advantage of competitors’ non-compliance or inability to enter a new market.
We believe we are entering a new era for regulatory affairs within the medtech industry. One in which RA teams have a seat at the table when go-to-market, competitive positioning, and strategic decisions are being made.
In the medtech industry, regulatory affairs (RA) teams have a broad range of responsibilities across the product lifecycle:
Premarket regulatory strategy
Obtaining market clearance for a new medical device is the primary activity typically attributed to RA teams. It is not unusual for a regulatory team to be given market entrance projects with little warning, but ideally, the RA team would be brought in as early as possible to contribute to go-to-market discussions.
Premarket regulatory strategy, at a minimum, involves:
- Determining the most appropriate pathway to market approval. For example, a 510(k) or PMA submission in the U.S.
- Working with quality, product, and other teams to gather information needed for market submission.
- Establishing communication with applicable regulatory bodies and third-party approved auditors.
- Compiling and submitting required documentation for market approval. This includes managing follow-up activities, questions, and requests for additional information throughout the approval process.
Forward-thinking organizations often look to bring in RA teams even earlier in the process. As regulatory experts, RA professionals can provide unique insight into product development plans. In consultation with R&D teams, can help to refine product strategies, and steer development in areas that will reduce regulatory hurdles when new products are ready to be commercialized.
Maintaining regulatory compliance for existing products
While the primary focus of regulatory teams is often considered to be new market submissions, the majority of their time is actually spent on maintaining compliance for products that are already in-market. Even in situations where market registrations do not expire, constant vigilance is required to ensure that devices remain compliant with current regulations. These efforts take a considerable time for a typical RA team because information is often spread across disparate systems, where it can be difficult to find and confirm.
Maintaining regulatory compliance for approved devices includes:
- Staying on top of changing standards and making changes as required to existing technical files and other documentation.
- Submitting appropriate documentation updates when there is a change made that could potentially affect the efficacy or safety of the product, such as a material switch or facility change.
- Understanding pending regulatory changes and proactively addressing any that have an impact on devices currently in-market.
- Tracking registration expirations and preparing for timely re-submissions to ensure there is no lapse in market clearance.
Post-market activity
Post-market surveillance and vigilance activities are required by most countries and should involve the cooperation of the quality and regulatory teams. Ensuring that changing post-market reporting requirements are understood and complied with is an important regulatory responsibility.
Regulatory teams typically play a role in:
- Post-market surveillance of adverse events, complaints, and any issues associated with a device in the field.
- Assembling and submitting any required periodic safety reports to country/regional health authorities.
- Post-market vigilance and reporting of serious events to the appropriate regulatory agencies.
- Any required communication with regulatory authorities regarding adverse events or concerning trends in product quality.
Ask any RA professional, and they are likely to tell you that they work long hours and are often scrambling to meet looming deadlines...
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™."
