Medical devices are being pushed out the door in the hopes of serving more people. However, these devices must PROVE to be lifesaving and effective, or else they won’t see the light of day. And although today’s technology has made it easier to crank out devices, it’s still important to consider the fact that easily-manufactured devices don’t happen by accident, and must be carefully considered throughout the development cycle, not just at the end of production.
With that in mind, here are 5 common things to remember to ensure that a medical device is manufacturable:
- Make Device Certifiable To ISO 13485
“Medical devices have to be certifiable to ISO 13485,” says Kathleen Arena, a content marketer at UKWritings and Revieweal. “This allows medical device companies to better manage rigorous and extensive quality control procedures, site visits, and vendor education.”
Such facilities include:
- PCB fabricators
- CNC machine shops
- Injection mold houses
- Label makers, AND
- Any other facilitative entity needed to fabricate a product
To achieve ISO certification, you must keep a comprehensive list of approved vendors with quantified performance metrics for manufacturing processes.
- Share The Right Information
Contract manufacturers will (and should) ask you for your Device Master Record, meaning that you’ll have to bid the project out, and they quote it. During this process, you’ll have to provide them with the right information on site. If you’re a new Medical device company, you might not have a Device Master Record built yet; but you still have to let manufacturers about that.
As you share information to prospective manufacturers, talk about the following:
- Any previous process validations
- Design requirements (provide different options to get higher yields)
- Your manufacturing space
- Pricing and volume expectations (so they can know a set point and determine expectations for you)
- Focus On Cost Reduction
Cost reduction is extremely important when developing a medical device. However, the further down the road that you go into a design cycle, the more difficult it is to make significant savings to your BoM costs.
But not to worry! You have options! With that said, here are some objectives to keep in mind:
- Focus on high cost items first by charting it to align subsequent cost reduction efforts accordingly.
- Talk to vendors about costs, along with quantity price breaks, projected sales, and alternative manufacturing processes that might impact your bottom line.
- Focus on the little things, too (i.e. labels, stainless steel fasteners, high end casters, high tolerance resistors and capacitors, and surface finishes), which can easily add 25% or more to a BoM cost.
- Always name value based on consumers (i.e. patients and practitioners). In other words, what do consumers want from your medical device, when it comes to costs?
- Ensure Fabrication And Assembly
“During the final stages of conceiving a medical device, you have to have a complete set of engineering drawings, along with a verified and possibly validated device,” says Daniel Knight, a business writer at Eliteassignmenthelp and Best Essay Services. “Once you have all of those things, you’ll need to iron out the kinks by ensuring that fabrication and assembly are done in a timely and correct manner. Therefore, it’s important to communicate this to your manufacturing company, so that they understand your constraints, as well as come up with the best solutions to complete the fabrication and assembly processes.”
- Make Device Integration Possible
Device integration has to do with risk mitigation (patient and project) and regulatory compliance. During these processes, it’s important for everyone involved to exhibit strong compliance and implementation of all components of a system. Compliance and implementation from everyone involved allows faster production, along with faster time to get the device to market.
Now, as you can tell, manufacturing a medical device is more than just creating something that has the potential to save lives, and better doctors and practitioners in their profession. Plus, manufacturing is more than just the monetary aspect of it (i.e. the costs of manufacturing, distribution, marketing, etc.). You have to pull your own weight in the product, and work with people and manufacturers to make it a reality. Although the scope of the work required to make a medical device manufacturable varies significantly (depending on technology maturity, cost targets, and company strategy relating to ongoing manufacturing), it’s still important to keep these 5 things in mind when making your medical device “manufacturable.”