You are the leader of a team developing a new medical device. Till recently, the project was running smoothly. You have an excellent, yet lean, team of talented engineers and scientists. The prototype worked well in initial trials.
The manufacturing process is really coming together. But now, many months into the project you feel like you’re in a quagmire. Recently discovered flaws in the product are proving to be more than an annoyance – they are holding up hitting some crucial milestones. The stakeholders are getting restless.
How did you get here?
I would answer that question with another question: did you implement Design Controls early in the development process? If the answer is “not really” or “kinda sorta,” or “partially” – you are not alone. Reasons for putting off Design Controls are plentiful and common: “we lack the resources;” “things are going so fast we just don’t have the time;” “it’s just a bunch of paperwork, we can finish that later.”
All of these reasons overlook a fundamental truth about medical device product development: the planning and discipline outlined in Design Control methods can help ensure the success of your development project and get your product to market with the minimum expenditure of time and money. In other words, Design Controls are not just a regulatory requirement – they are good business practice. Here are 5 ways Design Controls will help you get your product to market:
1. Design Controls Require User Input, thus Creating a Customer-Focused Product
One of the pitfalls of medical device design is the concept of innovation for innovation’s sake. Just because a product is innovative and exciting does not guarantee there is a market for it. Before putting forth the substantial efforts to develop a medical device, a company needs to determine that the end user wants and needs what the product will provide.
To facilitate this, Design Controls emphasize the drafting of User Needs. User Needs reflect the desired performance and functional characteristics of the product from a user perspective. Collecting suitable User Needs will ensure that your product truly has a place in the marketplace, and will help focus the development team’s energy on designing the right product.
2. Design Controls Save Time and Money
The FDA Guidance document for Design Controls states: “It is a well-established fact that the cost to correct design errors is lower when errors are detected early in the design and development process.” Design Controls help keep costs down by imposing a disciplined approach to defining and evaluating design elements throughout the development life cycle.
It also requires the development team to complete certain design milestones (documented in Design Reviews) before moving on to the next milestone. This helps to avoid the cart-before-the-horse phenomenon which so often trips up cash- and/or time-strapped development teams. I will be focusing on some of these milestones in more detail in future articles.
3. Design Controls Practically Create a Project Plan for your Development Team
Whether you are in a start-up or a large corporate environment, management wants to see a project plan with milestones and budgets. The wrong way to plan for a development project is to pick the date you want to finish and then back-calculate how much time you have to complete each milestone.
This is bound to fail and waste time and money in the process (see #2 “Design Controls save you time and money”). By knowing all of the activities that are required during the development process, one can reasonably forecast the timing and financial budget. This is why it helps tremendously to have an experienced staff who knows how long it takes to complete each of the milestones.
4. Design Controls Ensure that your Finished Product Works to Meet all of its Design and Customer Needs
I already mentioned that it’s important to identify your customer’s needs before designing a product. It is equally important, once you have designed it, to confirm that the product actually meets your design and user requirements. Design Controls force you to prove this using objective evidence.
This may seem like a lot of extra work, especially when the project seems to be almost over the finish line, but it’s better to find out now that an aspect of your device is insufficient then it is for customers to find out in the field – a very expensive and risky prospect. This is yet another example of how Design Controls save you time and money.
5. Design Controls will make your Regulatory Life Easier
Design Controls are a regulatory requirement, it’s true. The FDA reported that in 2014 Design Controls accounted for 13% of all 483s, behind only Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC).
But don’t be too glum about it, there’s a positive side to this story.
Imagine the following scenario: With a limited budget and resources, and with hard work, dedication and boot-strapping, your product received 510k clearance or CE mark. The product has been on the market for a while with minimal to no customer complaints.
Congratulations! However, skip forward a few months when the auditor shows up and asks to see the Design History File (DHF). It is uncovered that, in the company’s haste to get to market, some of the DHF elements had not been completed. The intent was always to go back and fill them in, but somehow it never happened.
The risk of receiving audit observations has now substantially increased. The amount of extra work it takes to fill in the blanks retrospectively is very time consuming, making you wish you had done it in the first place.
But, beyond that, there is another key issue: the fact that your device is working well even though you took some Design Controls short cuts only means you got lucky! The next time might be different, when design problems are discovered by the customer.
Lastly, there is always the risk that some design issues slipped through the cracks to bite you later – issues that very well would have been discovered during a robust Design Control process.
Coming Soon
In the coming weeks and months, I will be outlining some of the key details Design Controls. Hopefully this will help your product development projects deliver better products, on time and on budget while also meeting regulatory requirements. Remember: Design Controls are not just a regulatory requirement… Design Controls are good business practice!
