The scope of work required to make a medical device manufacturable varies significantly, and will depend on technology maturity, cost targets, and company strategy relating to ongoing manufacturing. This blog expands on 5 identified themes that precipitate from inquiries related to the genre of ‘making it manufacturable’.
Making a medical device manufacturable is a common scope of work here at StarFish. Devices that are easy to manufacture do not happen by accident, and it is important to consider this throughout the development cycle. There are many pitfalls associated with architecture (where all the pieces go and how to access them), vendor selection, and details like specifying the correct coating on a part that come with the territory.
Here are my top 5 ‘make it manufacturable’ suggestions with some great advice from colleagues:
1. ISO 13485 – Medical Device Companies often utilize facilities that are ISO 13485 certified to manage the rigors of extensive quality control procedures, site visits, and vendor education. This extends from PCB fabricators, injection mold houses, simple machined parts, and a host of additional items.
Tip #1 is Maintain a comprehensive list of Approved Vendors for a large breadth of manufacturing processes. StarFish is certified to ISO 13485 for our own in house assembly, fabrication and testing. We collaboratively work with external vendors to ensure that acceptable quality standards are continuously met, easing the already busy life of a medical device company. Here is a recent press release detailing some of StarFish’s credentials in this area.
2. Manufacturing Transfer – So you have a complete set of engineering drawings, a verified and possibly validated device, have made a few devices to iron out the major wrinkles, and want to order more on a continual basis, great! Now is the time to formalize assembly procedures, invest in jigs/fixtures, and have a team of dedicated assembly technicians ready to do so.
Gearing up to transfer before the device is fully vetted is also possible.
Tip #2 is talk to a manufacturing company so they understand your constraints and can collaboratively determine the best course of action. Dave Dobson highlights some of the key things to look for in contract manufacturers and why a large CM might be the right (or wrong) decision for you. Knowing when you’re ready can be a challenge, and Jason has provided a great perspective on some of his experiences with his blog post.
3. DFM/A/T/S Audit and Improvements – Design for Manufacture / Assembly / Testing / Serviceability, or DFX. This boils down to ensuring that the device can be put together repeatedly, efficiently and also maintained in a cost effective manner. This includes items such as:
- Having common failure elements easily removable (seals or delicate electronic components)
- Strategic a connection points for FATs (subassembly functional tests, test points or functional headers for PCBAs)
- Foolproof assembly (Poke-Yoke)
- Appropriate tolerances for a process with consideration to CTE, applied coatings, etc.
- Common fasteners
This is not a comprehensive list, and each device will likely have some special considerations and trade-offs associated with it – for example, disposable components need not worry about serviceability.
Tip #3 is Work with a company that also manufactures medical devices in house as well as designing them for the synergy that is available when engineers engage with experienced assembly technicians and manufacturing engineers to better understand the impact of design decisions. A more in depth look at one component of DFM for tooled parts is included in Boyd’s blog.
4. Cost Reduction – The further into a design cycle, the more difficult it is to make significant savings to your BoM costs, however, there are always options. Four top tips for cost reductions include:
- Focus on high cost items first. Draw a pie chart, and align subsequent cost reduction efforts accordingly.
- Engage with vendors. Often handcuffed by current manufacturing processes, vendors sometimes won’t ask for small capital expenses to reduce part costs. It’s also important to ask about quantity price breaks, projected sales, and alternative manufacturing processes that will impact your bottom line.
- Don’t forget about the little things. Labels, stainless steel fasteners (where zinc plated would suffice), high end casters, high tolerance resistors and capacitors, and surface finishes can easily add 25% or more to a BoM cost. Ask yourself what is driving component selection and finish. For ‘because it’s cool’ items that come up (probably specified by an overzealous engineer), be ruthless, unless they relate to DFX or key product requirements.
- Always consider the perceived value to the customer. This applies to both patient and practioner used devices. For example, refining the ergonomics and adding barium sulphate to an injection molded piece can increase the perceived value of a handheld device, and also decrease its cost, win-win! Marginal cost increases may allow you to charge more for your device and increase your margins. Be mindful of this when analyzing cost reduction exercises.
5. Device Integration – When the heavy lifting on the core technology of a device has been proven out, important work remains. Tip #5 includes things such as injection molded outer casings, carts, PCB layout, GUIs, or even brining two pieces of independently tested components together (such as microfluidic flow paths and novel sensor technologies). Working with a medical device contract manufacturer generally reduces your exposure to the many pitfalls of device integration, resulting in faster time to market.
The key items for this tip are risk mitigation (patient and project) and regulatory compliance. They typically require a fully integrated Alpha and Beta prototype. Vincent has two great blogs providing further insight on the topic.
Mark Drlik is a Mechanical Engineer and Project Manager at StarFish Medical. He uses the Pathfinder Process (TM) instead of the less successful “what doesn’t kill you makes you stronger” approach to making medical devices manufacturable.