Watch: When Is It Time for a Quality Management System for Your Early Stage Firm?
Starting up a medical device company takes a lot of time, money and effort. In addition to the research, fundraising, product development, clinical trials, etc., the FDA and other regulatory agencies require a quality system to be defined and maintained. But when is the best time to implement a quality system in your medical device startup?
On March 7th, Nicolle Cannon, CEO of the Cannon Quality Group hosted a live webinar in cooperation with Propel PLM. Nicolle provided guidance and best practices to quality systems implementation and answered questions from participants.
“I always hear from founders that this is an unknown area for them on when do we start that quality focus and when do we start the quality system implementation” Nicolle said at the opening.
“We don’t come with a black and white solution but we first take into account the stage of your business and help you get your product to market with that in focus.”
Nicolle described the approach with early stage organizations of helping them see their milestones and making sure they don’t take on too much burden with their quality system too soon.
“You can get started too early and it can handcuff you and you can spend way too much money too soon, or you can get started too late and again you can spend way too much money catching up and possibly delay launches.”
Nicolle says that for founders, a good rule of thumb is that as you move toward putting more money in the business, you want to systematically put some controls in place to reduce risk to your investment.
“When you’re funding a clinical that’s going to support a submission, supporting a claim, that’s a lot more money, so you want to be sure that design has some control around it.”
You can watch the webinar in its entirety here: https://bit.ly/2SRJ2mX