Are you unsure about when to introduce a quality management system for your early-stage medical device venture? Perhaps the step seems daunting and you’re putting it off?
Nicolle Cannon, founder of Cannon Quality Group, will be addressing this topic in an upcoming webinar on March 7. (More information here: https://bit.ly/2Wraz1y)
Some see it as the classic Goldilocks principle – if you start too early with installing your quality management system, you may run the risk of handcuffing your development process with rigid standard operating procedures and rules and thereby dangerously slowing your pace when what you want most of all is to get to market fast.
Or, if you start too late, you may have to backtrack and fill in gaps – possibly even retrace some steps and repeat some actions just for the sake of documenting them properly.
So when is the Goldilocks moment for medical device development?
It all depends on the company goals and milestones to market. What are the financing milestones? Feasibility Study, first in man, CE Mark? What kind of financing are you looking to have? Venture Capital, friends and family, strategics? Each of these items will drive the priority and the goldilocks moment.
At the end of the day, we are all here to improve patient’s lives and innovate health care with safe effective solutions. In this sense, no matter the end goal, having the documentary foundation of your design process will serve you well.
Early on in the process, when it’s just you, or just a few of you working nights and weekends, keeping track of the threads between user needs, how that informed design decisions, how that played out in the design outputs, and how you are testing that can be done with fairly simple off the shelf tools like spreadsheet apps and can play dividends in the long run. Before long, as you get closer to getting your design locked in, you’ll want to consider bringing on professional quality management resources.
“That doesn’t have to be a full time employee or even an inevitably increasing cost center,” says Nicolle Cannon. “In fact, in many cases, resources are deployed early on to get initial QMS needs established, then the ongoing quality activities can be fairly modest and stable for some time as you hammer out your final design. After which the next phase of your QMS can be implemented as it aligns with the company goals.”
This curve can wait to ramp up again until the flurry of activity around certifications and submissions.
Given the up and down nature of the quality activity, some startups are better served by outside contracted resources than employees. It’s a good investment for a number of reasons:
- Having a quality voice at the table helps you to avoid big (expensive) mistakes;
- It preserves cash and flexibility compared to an employee;
- It builds credibility with critical constituents like the board, investors, and early clinical supporters you’ll need on board;
- It increases your chances of a successful exit if your quality management system has been designed from the beginning to be “strategic partner friendly”.
For more on this topic, tune in to Nicolle’s live webinar on Thursday, March 7th at 10 am Pacific by registering here: https://bit.ly/2Wraz1y
About Us: Cannon Quality Group provides outsourced Quality Management System solutions to startup medical device companies that are engineer focused and compliant. Cannon’s number one priority is delivering QMS solutions that make sense for the stage and goals of its clients’ business. Cannon Quality Group’s mission is to be the Change in Quality. www.cannonqualitygroup.com