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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.
When you are ready to enlist a medical device manufacturer for your project, it’s vital that the documentation you provide is fully representative and comprehensive enough to enable an accurate quotation.
Your design package should include an accurate Bill of Materials (BoM) containing full component details and suppliers together with any information on parts that are either critical or technically challenging. It may be that your device relies on a particular supply chain or key vendors, and this needs to be understood at the earliest stage.
If you have already agreed on pricing for custom or key components with your elected supplier, ensure that you inform both your manufacturing partner and the supplier that the other exists. By doing so, you avoid confusion further down the line when your manufacturer’s price does not match your own because the supplier was not aware of any relationship.
In order for a contract manufacturer to quote on a project, 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 projects at any one time and have to share limited resources amongst multiple customers. 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 project to include the correct labor costs. This can be aided by having a clear set of instructions or assembly drawings available. Importantly there are things such as test procedures – both at PCB and module-level but also at a 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 quotation. If you do have test procedures in place, make sure you have provided all the test information to accurately cost the time required.
The final documentation package for a medical device needs not only to be accurate and descriptive but also compliant with the appropriate regulatory standards. Certain documents are essential such as manufacturing instructions, test specifications, and labelling specifications.
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.
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 and components 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 (PCB) specifications in a transferrable format, i.e., Gerber files
– Details of test jigs or fixtures
Before any device leaves production, it is critical that both the device itself and the process in which it was 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 guarantee a smooth transition;
– Specific tools, jigs, or fixtures needed
– Software installation
– Critical components/suppliers
– Environmental conditions
– Process operating procedures
– Build processes
– Test specifications (PCB, module, and system-level)
– Packaging
– Specific training requirements
– Devices subject to validation
Requirements sometimes change through a product’s 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 significant delays; therefore, it’s always best to provide a contract manufacturer with a fully finalized 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.