9 Questions to Ask to Create a Foolproof Manufacturing Plan for Your Medical Device

Nothing about launching a new medical device is simple. From the FDA’s regulatory requirements to usability testing, medical device development can seem downright byzantine. Unfortunately, the same thing goes for medical device manufacturing. With so many interdependencies at play, creating a manufacturing plan is itself complex and time-consuming.

Which means that you should never wait until the last minute to hammer out the details of your new medical device’s manufacturing plan. By creating a comprehensive and accurate manufacturing plan early in the development process, you can make informed design decisions, minimize unwanted surprises, and take your medical device to market on time and on budget.

Here’s what you need to know to get started on this important planning document.

Whether You Physically Manufacture Your Device or Not, You Are the Manufacturer of Record

One thing you must understand: In the FDA’s eyes, your medical device company is the “manufacturer of record” for any device you bring to market. What does that mean? It means that you are ultimately responsible for the safety and efficacy of your product. That’s true whether you build everything in-house or subcontract it all out.

For that reason, you’ll need to qualify any manufacturing suppliers you want to partner with before you can begin tooling. The qualification process can be time – consuming — and may involve applying quality management system principles in your company — so you’ll want to account for this time in your project plan.

Your manufacturing plan is a required piece of your design history file — the submission packet you must send to the FDA in order to receive approval to take your device to market. As with many elements of the FDA’s medical device submission packet, there’s no official form or document you must use in preparing your manufacturing plan. This means you’ll need to do your due diligence and craft a plan that takes all the most important factors into account.

When Should You Start Crafting a Medical Device Manufacturing Plan?

When it comes to creating a manufacturing plan, the sooner you get started, the better. Ideally, you should start putting together your manufacturing plan in the earliest strategy phases of a new medical device project. If you wait until after you design your product, you’ll already find yourself behind the curve.

That’s because manufacturing isn’t a standalone operation. Your manufacturing plan is inextricably interwoven with other decisions you’ll make in the medical device design and development process.

For example, knowing your anticipated production run (the number of units you plan to manufacture) will directly impact your target cost per unit. In a similar manner, your manufacturing suppliers’ unique capabilities and equipment may limit your design decisions.

Preparing a manufacturing plan at the outset of your medical product’s development forces your team to think through all of the many manufacturing-related interdependencies before you get started.

9 Key Questions to Ask Before Building Your Medical Product’s Manufacturing Plan

Ready to get started with your manufacturing plan? Be sure to take the following key questions into consideration:

1. Broadly speaking, what does your medical device consist of? Is it a hard good, a soft good, a piece of software, or something else entirely? What are your device’s main components, and what are they made of? The answers to these questions will get you thinking about what sort of manufacturing suppliers you’ll need to partner with, if any.

2. What is your first planned manufacturing run? How many items do you plan to manufacture out of the gate? A ballpark figure will suffice if you don’t yet know the precise number.

3. What is your manufacturing strategy? Will you manufacture your product yourself, sub it all out, or do something in between (for example, complete sub-assemblies externally, with final assembly in your facility)? Do you prefer to partner with any particular manufacturing suppliers? What about overseas versus domestic? And finally, do you need your manufacturing partners to possess other capabilities, such as warehousing?

4. What are your capital equipment needs? What tooling and other capital equipment will be required to manufacture your medical device? And, given your product’s expected time on the market, how long should the tooling last? For example, should it be built to produce ten thousand parts or a million parts?

5. What is your supplier qualification plan? Have you selected your manufacturing suppliers? If so, which of them still need to be qualified in order to produce your medical device? What steps do you need to take to qualify your partners, and how long do you expect the full process to take?

6. What is your plan for manufacturing verification and validation (V&V)? Just as you must verify and validate your medical device, you must also verify and validate your manufacturing equipment. For example, if you are investing in new tooling, you’ll need to perform a moldability review, a tool design review, a first article review, and a molding process validation Your manufacturing equipment and fixtures may be subject to a so-called “IQ/OQ/PQ,” which is a series of installation, operation, and performance qualification studies. These quality control procedures are required for medical device manufacturing. (And they are best practices in manufacturing, period.)

7. What are your labeling and packaging requirements? All medical devices and their packaging include strictly regulated labeling. Which labeling and packaging regulations apply to your device, and how do you plan to fulfill those requirements? For example, there are multiple ways to print serial numbers on a product. You could choose to include a label printer on your production line, or you could buy a roll of pre-printed labels.

8. What about manufacturing documentation? For each medical device you manufacture, you must document your manufacturing process to prove that you have satisfied various requirements. Which elements of your manufacturing process need to be documented? And how do you plan to collect, organize, and store the necessary information?

9. How will you handle reviews and approvals? Finally, consider how your team will handle manufacturing reviews and approvals. Who will need to sign off on your manufacturing plan, tooling, prototypes, and so on? By being as specific as possible in documenting your review and approval process, you can avoid confusion and increase your team’s efficiency.

No doubt about it, medical device manufacturing is complex. But with careful planning, you can pave the way for a seamless production process that goes off without a hitch.

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