We recently hosted a Product Development Seminar at Cambia Grove in Seattle. The event featured talks by Product Creation Studio experts and guests on different aspects of the product development process, as well as the overall ecosystem of getting a product to market.  

Please follow our Product Development Seminar blog series for new content and videos from the event.

Maren Nelson, a PMP-certified, medical device consultant, served as our Quality Management expert during the seminar's Q&A panel. Maren is an experienced professional in the use of risk management and process improvement, as well as the development and regulatory approval of medical devices.

Below are the question and answers pertaining to Quality Management Systems. A video of the session can be found at the end of the blog post. 

At what point should a product startup company establish a quality management system?

As early as possible.

Quality systems are lawful regulations, established on a country-by-country basis. I will be talking about the U.S.-specific quality regulations here, but keep in mind that they can be applied worldwide.

For context, let me give you a quick overview of what medical device regulations are designed to do … and there are more to them than just submitting a 510k application.

The basic role of the quality management system is to document the reason for any decision or change you make in order to argue that it is the correct decision.

How many of you don’t track your changes and reasoning for the sake of just “getting it done”, thinking that you’ll remember and write it down later?  The problem is that you forget about 90% of the sound logic you used to make the decision you did if you wait until after the fact.

Can you give me some examples?

Manufacturing example: If you’re settling on a manufacturing process for your medical device, you need to document the acceptance criteria you’re using to say whether the product is good or not and why your criteria are sufficient.

Design example: Design verification, design reviews, risk assessment, design validation, etc. are all examples of QA process documentation you can submit to describe why you are making the decisions you are.

I don’t have the budget to establish a formal quality management system. What steps can I take now to make it easier in the future?

Most companies tend to wait to establish a formal quality management system after funding, but I’d encourage everyone - from the start of your company - to write down why you’re making the decisions you’re making.

Don’t get hung up on the format of the documents, approval processes, etc. at this point. What you’re looking to capture is the information about why you’re making those design decisions.

If you write it down from the get go, you’ll have a great foundation by the time you have received the funding and are ready to do your first real prototype. It will make the process a lot easier.

What are some general principles of a quality management system?

Quality management doesn’t just define the design of the product, it has a much broader scope that entails how the company operates, the design, the manufacturing, the after-market, etc.

There are three main things to remember when implementing a quality management system:

1. Quality management is about defining why you made a decision and making sure it’s documented.

2. If you decide to outsource an external supplier (for design, manufacturing, etc.), you need to write down the criteria you used to select that company. Even if you use a supplier, it does not remove your accountability as the manufacturer of the medical device … quality management cannot be passed on. You own it as the product owner.

3. The management team is always accountable, no matter what happens. As the leader, it is your responsibility to make sure the people you hire have the appropriate training and skill set for the position you put them in (whether it’s a partner, vendor or employee).

Conclusion

As you’re setting up your company and applying the general principles covered above, you will be well-positioned to adopt the formal procedures later and thus, get your product to market faster.