Transferring design to production is a process that can be fraught with risk for medical device developers. How can you be sure no one in your supply chain drops the ball as they assume control of the product you’ve taken so long to design and develop?
What do the FDA and ISO 13485: 2016 say about design transfer?
Both requirements are short and to the point:
The FDA says:
“Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.” 21 CFR 820.30(h)
While ISO 13485:2016 states:
7.3.8 Design and development transfer
The organisation shall document procedures for transfer of design and development outputs to manufacturing. These procedures shall ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements.
What can go wrong in device design transfer?
If your manufacturing team or partners don’t have access to approved and verified designs at the right time in your process, it can lead to error stacking, delays, wasted materials, increased costs and sub-standard products rolling off the production line.
How can you ensure you avoid the mistakes that lead to non-conforming products and wasted effort at this critical part of your route to market?
Here are 3 steps to meet the regulation, keep your timelines intact and ensure you get maximum value from your manufacturing partners:
1. Think about transfer to manufacturer from the start
Developers need to be thinking about DfM (design for manufacturability) throughout the design and development process - and definitely (as ISO 13485 demands), before final production specifications are in place.
To ensure your planning reflects future design challenges you should:
- Factor risks around design transfer into your initial risk management matrix - so they are addressed in your design control and validation planning.
- Ensure manufacturing requirements gathering happens as standard within your design control process.
- Loop manufacturing specialists into iteration cycles - so your designs are scrutinised by experts for viability and can be optimised with DfM in mind at every stage.
If you have these design controls in place before you begin, you could save yourself major headaches later on. Among other things, they can help you ensure:
- Bills of materials are checked by experts for parts availability and obsolescence.
- Designs are checked to ensure tolerances are acceptable before you begin production.
- Manufacturing processes are optimised for efficiency and compliance.
2. Collate required documentation as you work
Both the FDA and ISO 13485:2016 require you to compile the ‘technical documentation’ as a definitive instruction manual for your production process. The FDA calls this the Device Master Record:
- Design specifications
- Production Processes
- Equipment specifications
- Packaging and labelling specifications
- QA procedures
- Maintenance and servicing procedures
- Acceptance criteria
But if you’re going to collate this documentation effectively and get the right people to review it at the right stage - you’re going to need the document controls in place to make it happen.
Using Google Drive to assemble all this information is going to be hard. You need to have a plan for systematically generating it all, and the tools for sharing without data becoming lost or corrupted.
Choosing a document control system (DMS) in which you can create digital templates for the collection of this documentation will be invaluable. These systems will let you automate the steps required to generate specific files, and then have them approved by the required stakeholder as part of a phase-gated design process.
They will let you send documents securely to third-party suppliers to append comments, or even ask them to add their own documentation for your review, without losing control of the files in prolonged email exchanges.
A good DMS should let you develop and update packages of documentation like the Device Master Record in real-time. And it should automatically collate them in a single location as you work, preparing them for fast and effective transfer to manufacturers in the future.
The alternative - retrospectively pulling files together from different digital locations - as many developers will attest, can be a painful process that risks confusion and mistakes.
Read this blog for more information about the process of creating a Device Master Record.
3. Define and follow requirements for design transfer
Finally, you need a documented and controlled process for transferring your final designs to your manufacturing partner. And you shouldn’t rely on email, One Drive or We Transfer to help you do it.
Mistakes happen. E-mails don’t get delivered. Attachments and recipients are omitted. Files are mislabeled. System security can be compromised.
Dedicated document management software can help you mitigate these risks. If you’ve not got the workflows in place to manage required design files and funnel them into specific folders for review before release, it’s all too easy to send the wrong version to the wrong people.
An ‘extranet’ solution can help you collate your DMR in one place as you work, then open up a secure part of your system for suppliers with permission to download the required package.
With the right tools you can track who has downloaded what and when, so you can be sure your supplier has accessed the details you have sent them.
The FDA and ISO 13485 requirements for design transfer are short and to the point. Achieving compliance really depends on how you've previously structured your document and design control process within you QMS,
If you’ve got a compliant document control system in place you will be able to:
- Collect DfM requirements as part of your design process
- Share required documentation securely with your manufacturer
- Ensure the accuracy and integrity of the design data you share
- Template, replicate and automate the process for the future
And. what’s more, you’ll have all the evidence stored in a single place to prove that you’ve done so to future auditors.