PITTSBURGH– Rimsys, the leading provider of Regulatory Information Management (RIM) software for the medtech industry, today announced it closed $16 million in Series A financing led by Bessemer Venture Partners, with participation from existing investors Allos Ventures, Private Opportunities, and Innovation Works. The company also announced the appointment of two industry veterans, Adam Price and Christine Robertson to its executive team, and that Bessemer Partner Andrew Hedin and Pendo Co-Founder Eric Boduch have joined Rimsys’ board of directors.
The Rimsys cloud-based RIM platform helps global medtech companies streamline regulatory processes, strengthen compliance, and get new products to market more quickly. Designed specifically for medtech regulatory affairs, the platform includes an integrated data hub for all regulatory information and documents, ensuring that teams can easily access critical information and put it to use in pre-market submissions, establishing and maintaining market authorization, and proactively managing post-market surveillance.
Growing regulatory complexity is making it difficult for medtech companies to keep pace. In 2020 alone, the FDA issued over 70 guidance documents focused on medtech products, while research from MedTech Europe predicts that as many as 76% of medical devices (including in vitro diagnostics) will be withdrawn from the market as a result of the new MDR and IVDR regulations in the European Union. Companies that have traditionally relied on costly outsourcing and cumbersome spreadsheet-driven processes to manage the administrative burden of regulatory compliance can now increase efficiency and improve compliance through the digitization and automation of their regulatory activities via the Rimsys platform.
“When I led regulatory affairs teams, we were always behind,” said James Gianoutsos, Founder and President of Rimsys. “We struggled to find information, struggled to meet audit requirements, and spent a fortune on consultants as a result. The Rimsys platform was born out of necessity based on those first-hand experiences. The transformations we’ve seen in our customers are incredible. They’re able to improve compliance, keeping products in the market for the patients that need them the most, while dramatically reducing the amount of time spent on manual administrative activities. Our goal is to build a truly comprehensive software platform for medtech regulatory affairs, and we’re now in a position to provide support for a broader set of regulatory activities that will help them even more.”
The Rimsys platform empowers regulatory affairs teams to more proactively manage product registrations, standards, essential principles requirements, UDI requirements, post market surveillance activities and regulatory documents across the product’s lifecycle. It connects regulatory information across the business, making it more easily accessible, and accelerating regulatory activities such as new premarket applications or general safety and performance requirements maintenance.
Rimsys has experienced more than 300% revenue growth so far this year, and counts global medtech companies such as Johnson & Johnson, Siemens Healthineers, CooperSurgical, and Omron among its clients. The financing will enable the company to continue its growth through new product lines and geographic expansion.
The company also announced two new executive hires with extensive medtech industry experience. Adam Price, former Head of Post-Market Surveillance at Philips will lead post-market product management and strategy, helping the company to develop new offerings focused specifically on that part of the regulatory lifecycle. Christine Robertson, former IT Leader and Regulatory Affairs Business Partner at Thermo Fisher Scientific will lead implementation and professional services, bringing best practices for large-scale RIM deployments to all Rimsys customers.
“We are thrilled to partner with Rimsys and support their long-term success,” said Andrew Hedin, Partner at Bessemer Venture Partners. “As healthcare investors, we saw the ever-changing complexity and growing global regulatory pressures that medtech companies are facing. This industry can no longer rely on error-prone antiquated processes and legacy technologies that put product sales at risk. Rimsys is transforming a sector that has been underserved by new technology with their best-in-class, scalable platform that meets the needs of medtech companies of all sizes.”