Quality systems might be the last thing on a start up’s mind. There are other activities that might be perceived to add either more value or more meaning to the start-up’s goals. However, it is not a good idea to overlook the development of your quality system.
“I think it is a good idea to put process and product planning in place right from the start, simply because once things get going, they get going fast,” says Timothy Lozier, director of marketing for ETQ. “You’re might be too worried about R&D, product and supply-chain, and then market approval to think about compliance. But it will come to you, and you don’t want to get caught off guard.”
Implementing and maintaining a quality management system (QMS) is a crucial part of regulatory compliance. The medical device quality system is primarily concerned with production and post-production. FDA 21 CFR Part 820 defines the quality regulations for the U.S. market. Otherwise, ISO 13485 can be used to build a quality system for global markets.
The process of establishing a total quality management system is time consuming and expensive. But building that quality system need not be as challenging as it sounds. The key is to build the quality system as you develop, focusing on the relevant aspects of quality and ignoring the others until they are needed. “You have to find something you can scale with,” says Lozier. “There are systems out there that let you start off small-scale and simple (yet effective), but as you grow you can grow the solution with your business.”
Start-ups can add in some quality and compliance in the development phase. The principles companies should focus on first are design controls, risk management, document control and record management, and supplier management.
Not only are design controls essential for a quality system, they can actually help with the design process by capturing key aspects of medical device product development to prove your product meets user needs and is safe and effective. Likewise, risk management works with design controls to create documents and records throughout product development to demonstrate you have considered the risks and are doing something about it. Document management is the process that helps those pieces of the puzzle stay together.
“The concept of planning and gaining control over the process is that as you grow, you’ll always have them to lean on,” says Lozier. “People can follow a process, but if it’s not documented, then you run into issues.”
Lozier emphasizes centralizing documentation, process and product planning. “Too often, companies make that first step towards documenting their processes, but it resides in spreadsheets, file systems, and other, more decentralized, often manual methods. Having a system that is able to manage and track these things, as well as serve as a central resource is important to ensuring consistency in the operation. One source of the truth outweighs the risks associated with errant copies floating around the operation.” The FDA’s guidance documents can provide further detail for design controls.
Lozier says there are tools that can offer free or scalable methods to handle compliance events, issue actions, and launch CAPAs. ETQ, for example offers traqpath, which is free to download. The company also offers VERSE, a cloud-based quality management system that brings in document control/training, and CAPA. In addition, both tools have a supplier component to them, which can help start-ups send actions and CAPAs to suppliers through secure external assignments.
Many vendors have programs that are specifically designed to help companies scale compliance. “These are not expensive tools, but are built for the startups in mind,” says Lozier. “The benefit is that, if you are a startup and you’re looking to just put the pieces in place, you can do that for a low cost to your business, or even for free. That way, you’re not ignoring it, or factoring in major investment on something you may not need now.”
Investment in compliance is a futureproofing investment, says Lozier. “You are going to have to meet the compliance standards and regulations as you grow, and, just like documenting your processes and controlling and tracking your Quality and Compliance operations, you don’t want to be caught in growth mode and playing catch-up.”
