Staying at the forefront of the medical device industry takes work - a lot of it, in fact. Communication with R&Q's peers in the industry is in large part how our employees do it, and a big part of that is addressing hot topics in the industry. R&Q's own Client Solutions Advisor Christine Santagate was featured in MassDevice's May 2016 issue of Medical Design and Outsourcing in an article titled, "Everything You Ever Wanted to Know about Starting a Medical Device Company." The publication serves as a fantastic how-to guide for startup companies. Here's what she had to say.

Medical Design and Outsourcing

In the feature, Christine discusses the do's and don'ts of quality and compliance for startups. She reminds these companies to get started early; don't ignore the development of your quality system at the beginning!

“Establish a quality management system that suits the company size and expected growth,” she says. “Make sure that it’s something that the current staff can manage and maintain. When a company institutes a [quality management system] that’s too large, they set themselves up for failure to comply with their own system.”

To plan the regulatory strategy effectively, Christine also mentions some key pieces to keep in mind. First, startups should remember to budget for the testing and related costs associated with regulatory processes. Next, an early consideration of where to gain approval first. In the past, Europe has been a popular location due to less strict requirements as compared to the FDA, but Christine explains this is changing due in part to the updated ISO 13485 standards. If the U.S. is the target, develop a regulatory strategy upfront, identify risks, and plan potential paths. 

“This strategy will assess applicable FDA regulations, device classification options, potential predicate device and product claims, indications and contra-indication options, and potential regulatory risks based on the company’s marketing claims, product requirements, risk analysis, etc.,” Santagate says. “The advantage in working with a consulting group is that they stay up to date on all regulation changes. A group like R&Q has 80+ full time consultants with experience spanning nearly all FDA device classes and they can provide an experienced, independent review.”

Lastly, Christine says a sound regulatory strategy can be an unexpected benefit for startups when it comes to funding from investors.

“Potential investors are able to see that the company has a planned path forward, based on risk. It provides an additional layer of preparedness and overall understanding of the full funding requirements – and how those funds will be used,” she says.

It's always exciting to be included in a publication like Medical Design & Outsourcing. Special thanks to MassDevice for shedding light on startups and for quoting Christine.

Take a look at all the ways R&Q can help your medical device startup on our Services page.

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Check out the full issue of "Everything You Ever Wanted to Know about Starting a Medical Device Company." 

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