If you're at the ground floor of a new medical device startup, it's easy to get caught up in the rush as your company hurtles toward the next product milestone, the next round of investment, and the next steps in getting to market.
However, if you're overlooking the critical details of regulations that permit you to sell your device, you could find yourself swamped in paperwork before you can get to market, or worse, not make it to market at all.
Jon Speer, founder and VP of QA/RA at software firm Greenlight Guru, lists five things to start addressing right from the beginning to ensure your regulatory submissions are ready to go at the same time as your product.
Establish a design history file
Design history files are required by law as part of your firm's quality system. A design history file contains all of the documentation that you generate in regards to the design of your product. The following documents should be present:
- Design controls - documented procedures that describe your company's development process;
- Product user needs - details of how your product will be used, what problems it solves, and what features it requires;
- Design plan - defined responsibilities and milestones for your design process;
- Design inputs - a document describing all of the product requirements for your medical device, including physical, functional and performance requirements; this should be based on user needs
Create a regulatory strategy
Determine where you intend to sell your medical device and determine its product classification in accordance with local regulations - this will tell you exactly what regulations apply to your device and will inform your regulatory submission process later on.
Establish a risk management file
All regulatory bodies for medical devices are concerned with risk management and you should be too. Establish risk management procedures, and define and document a risk management plan for your product's entire life cycle, even through development. Identify any hazards associated with your device, and start a risk assessment - identify any potential harm it could cause, the likelihood of occurrence and what severity could be. Document all of this in a risk management file.
Build relationships with suppliers
Figure out what materials you'll need for your new device and establish a system for choosing suppliers. Base it on price requirements as well as quality. Create a list of approved suppliers for the various materials you need, and keep files on suppliers you may wish to work with in the future. It's important that you fully understand the materials used in your products, and that you trust the companies that sell them to you.
Establish document controls
Document controls may belong at the top of this list. As you create your product, you'll generate plenty of records, and it's important to have a system for organising and maintaining them - they'll later be reviewed by the FDA, ISO, and possibly others to establish your compliance with medical device regulations. The best way to ensure smooth audits and get to market quickly is to maintain great document controls from the outset.
Final word
Getting to market as quickly as possible not only means building a great product that solved a real medical need safe and effectively, but it also means being quick to establish compliance with the appropriate regulations. You may have the best product in the world, but the FDA wants to see that you're organised, diligent, and willing to play by the rules before your product makes it to the shelves. Remember we’re building medical devices. If you can address the five items above, you're off to a great start.
