Top 10 Questions to Ask Your Prospective Medical PCB Manufacturer
Whether you’re looking to change supplier or are outsourcing for the first time,
you want to know that the company you are partnering with has the right experience and expertise.
So, what should your key criteria be for selecting your medical PCB manufacturer?
Here are ten key questions to ask that will help you to easily make comparisons:
1. What will my order cost? What are your lead times?
Cost and lead times are going to be the primary factors in your decision – in our industry everyone’s looking to get best value for money and has deadlines to keep to.
But don’t look at these in isolation – it’s important not to sacrifice quality for speed. Make sure you strike the right balance between quality, value and delivery.
2. What regulatory approvals do you have?
A manufacturer doesn’t have to have medical-specific regulatory approvals such as ISO 13485 if they’re only producing the PCB that is integrated elsewhere.
However, if they do have a quality management system (QMS) in place, you can be sure that the entire process of purchasing, producing, handling and testing PCBs is highly controlled and highly repeatable. Looking for a PCB manufacturer with these approvals will give you extra security and protection.
3. Do you have a process validation procedure?
Some subcontract PCB manufacturers will produce straight from your bill of materials, others validate their processes before they start. Process validation is a way of ensuring high yields before manufacturing starts as opposed to having to rework boards that fail.
What you need depends on factors such as which markets you are selling in to. E.g. if you sell your device in the USA, your process will need to be validated to FDA standards. As a critical part of the device, the FDA may want to audit your PCB supplier.
4. What level of traceability will my PCBs have?
Traceability can range from critical parts to full component level and the level of traceability needed depends on the class of your medical device. For a low-risk Class I device you may only need the critical parts to be traceable and if these aren’t on the PCB your manufacturer may not need any traceability at all.
That said, it is worth considering the balance between what is required by regulation and what makes sense to protect your business and your customers in the future.
On the subject of suppliers it’s always good to dig a little and find out where a manufacturer sources components from to ensure that their suppliers are reputable and able to handle demand.
5. What’s your capacity? Could you handle increased orders as I grow?
Your manufacturer may be able to produce the volume of PCB’s that you need now, but will they still be suitable in future?
You need to consider whether you want to go through the process of knowledge transfer, re-training and re-validating when your volumes increase or whether you would rather select a manufacturer that can grow with you.
You should also ask your manufacturer how flexible they are. Do they insist on minimum order quantities? What fixed forecasts will they hold you to? Could they still meet lead times if you double your order quantity?
6. Can you meet our device-specific requirements?
If your device has any specific requirements such as flexible PCB’s, multi-layer boards or uncommon storage conditions, don’t assume that every PCB manufacturer has these capabilities.
If you find a near-perfect fit but they don’t have everything, ask if they would be willing to invest – this is also a good test of their commitment to you as a customer.
7. What do you have in place for ESD protection?
Electrostatic Discharge, the sudden transfer of electricity from one object to another, can damage components. The smallest amount that can be felt by a human (when you touch something and feel an electric shock) is around 2000 volts, but sensitive electronic components can be damaged by as little as 20 volts of static electricity.
There are a multitude of measures that a PCB manufacturer can put in place to mitigate the risks of ESD damaging your boards and they should be able to demonstrate them to you.
8. Can you provide supply chain management?
Can your manufacturer take on value-added activities such as supply chain management? There are more burdens in this area than you might think, examples include auditing suppliers, negotiating prices and RoHS compliance.
If your business isn’t geared up for sourcing and handling components you may be better off outsourcing this to your manufacturer too. Plus, they will already have good relationships with component suppliers so might be able to get preferential terms.
9. What is your critical parts inspection protocol?
According to the requirements of ISO 13485, if your critical parts list includes components on your PCB, these need to be inspected at goods-in and recorded by the manufacturer. A specialist medical device PCB manufacturer will have this built in to their process, whereas a general Electronic Manufacturing Services (EMS) company may not.