Startup company Rimsys (Pittsburgh) has launched its its first software solution that helps medical device companies effectively manage regulations around the world.
Delays or blocks to medical devices entering the market can be caused by things like mismanaged information. Rimsys is trying to alleviate that problem with its software by giving them a platform that companies can use to understand regulations that can affect their product pipelines and portfolios.
“Getting a product to market is tough enough from a development standpoint,” said James Gianoutsos, founder of Rimsys, in a press release. “However, complying with each country’s requirements accurately and on-time can make or break its entry. That’s where Rimsys shines.”
Gianoutsos developed the software based on his industry experience and feedback from an advisory board that has top regulatory leaders from a number of global medical device companies. The leaders provided feedback like how often they have to hire specialized consultants to help manage the changing regulations and how their product requirements are affected. The leaders also suggested their their internal teams are not equipped to address compliance issues alone. Rimsys helps address those problems by giving companies an interactive platform that allows team to manage products, countries, regulations, standards, guidelines, accounts, contacts and regulatory bodies.
“Professionals need a way to properly manage this information,” Gianoutsos said. “Regulatory intelligence by itself isn’t of value until your organization applies it. How does this information impact products? How does it impact country representatives? Our system doesn’t allow critical action items to fall through the cracks.”
A recent Emergo Group survey noted that changing regulatory environments will be a top concern for medtech companies this year. About 68% of industry senior managers and executive said that changing regulatory environments is one fo the biggest challenges their company faces. Additionally, only 55% of survey respondents reported only having a basic understanding of the changes occurring.
“We know this isn’t just a medical device industry issue. It’s a general regulatory management issue,” Gianoutsos said. “That said, there is opportunity to expand Rimsys beyond medical devices. However, the company’s current focus is where the biggest need is, and that’s the medical device industry.”