ITL Insights: How to Ensure a Smooth Manufacturing Transfer
It’s one thing having a product or device designed to perfection, but ensuring your device gets to market on-time and within budget is highly dependent on the transition between design and manufacture.
Volume manufacture is a complex part of the process and getting it right (first time) will help determine your chances of commercial success.
The following steps offer a guide to help ease the transition between product development and full-scale manufacturing, but remember, this is not the complete story and it’s vital that businesses consider the whole production cycle in their planning.
1. Ensure your quotation package is in order
When you are ready to enlist a contract manufacturer it is vital that the documentation you provide is fully representative, and comprehensive enough to enable an accurate quotation.
The documentation should include an accurate Bill of Materials (BOM) with full part details and suppliers together with any information on parts or components that are either critical or technically challenging. It may be that your device relies on a particular supply chain or key vendors, and this must be understood at the earliest stage.
Furthermore, if you have already agreed pricing for custom or key components with your elected supplier, make sure that you inform both the manufacturer and the supplier that the other exists. This avoids confusion later on when the manufacturer’s price does not match your own because the supplier was not aware of any relationship.
2. Have a realistic timeline
In order for a contract manufacturer to quote on a device, they will need to cost the BOM accurately, and this may take time depending on the supply chain response, again the more accurate and descriptive your BOM is, the faster the process will be. Also, most contract manufacturers will be handling multiple clients at any one time, and have to share limited resource amongst multiple needs. This means that each individual quote may take a little longer depending on how busy they are when you reach out.
The sub-contract manufacturer will also have to calculate the manufacturing time for the device to include the correct labour costs. This can be aided by having a clear set of instructions or assembly drawings available. Importantly here are things such as test procedures – both at PCB and module level but also at system level. These all take time and need to be costed accordingly. If you don’t have test procedures, make this known to your chosen supplier at the time of quoting. If you do, make sure you have provided all the test information they will need to accurately cost the time required.
3. Finalise the documentation package
The final documentation package for a medical device needs not only to be accurate and descriptive, but also compliant to the appropriate regulatory standards.
There are requirements for Design Transfer in both ISO 13485:2016 and FDA 21 CFR Part 820, however the requirements allow the manufacturer to define their own process.
The end result should be a Device Master Record (DMR) for the FDA or Medical Device File (MDF) for Europe. Both requirements are very similar and any DMR or MDF may come under scrutiny during an audit or FDA inspection.
Certain documents are essential such as manufacturing instructions, test specifications and labelling specifications.
4. Manage the Design Transfer Process
Communication at a professional and technical level is crucial to ensure that any ambiguities are ironed out, as this can be a costly exercise after making the transfer from design to manufacture. It is vital to look carefully at the whole process, including:
- Parts, from specified or critical vendors
- Incoming inspection criteria for critical parts or assemblies
- Special environmental conditions
- Does the manufacturing process use dangerous substances?
- Printed Circuit Board specifications in a transferrable format i.e. Gerber files
- Details of test jigs or fixtures
5. Validate the process
Before any devices leave the manufacturing environment it is critical that both the individual devices and the process under which they were built is validated. The extent of the validation can depend on the complexity of the device or the process. It’s worth validating the following to ensure a smooth transition;
- Specific Tools, Jigs or fixtures needed
- Software Installation
- Critical Parts / Suppliers
- Environmental Conditions
- Process operating procedures
- Build Processes
- Test Specifications (PCB, Module and System level)
- Specific Training Needs
- Instruments subject to validation
6. Minimise change
Requirements sometimes change through a products development but always aim to create a stable footing for the design to be based upon, rather than a quicksand approach where things are constantly changing. Making changes throughout the development process can incur serious delays, therefore it’s always best to provide a contract manufacturer with a fully finalised DMR.
Whilst most contract manufacturers will have an Engineering Change Process or similar for handling these changes, they can cause additional costs in both manpower and also in parts if it happens after an order has been placed and raw materials ordered.
Get the full-service picture
ITL Group have a full knowledge of the production cycle, with skills and expertise built up over 40 years as a contract full service design and manufacturer of medical, diagnostic and analytical devices. Wherever you are in the product development life-cycle, our team can help. We continue to push the boundaries and utilise the latest technology to produce world leading med tech devices. ITL are seamlessly able to handle all your device needs, taking your idea from initial concept to full scale commercial production.
Chat with a member of our team today to find out more, contact us.