This article covers 33 tips and examples from sixteen StarFish Medical experts for Phase Three Manufacturing of medical device commercialization.

Tips for all four phases of medical device commercialization are now online: Phase Zero Product Definition, Phase One Engineering Design and Development, and Phase Two Medical Device Transfer to Manufacturing.

Phase Three Manufacturing topics cover Business Considerations, Supply Chain, Inventory, Quality Control, Assembly, Service and Support, and Working with Contract Manufacturers.

Business Considerations

Consider starting with a minimum viable product (MVP) and getting that to the market to understand the market and earn a revenue stream. When designing a higher volume efficient product, you will have a revenue stream to pay for development.

Understand the window for your return on investment on additional engineering efforts during the manufacturing phase. There are myriad optimization opportunities. Determine cost-benefits and expected duration before making manufacturing process changes.

Set expectations around production readiness and esthetics. For example, how much work should you spend getting defects out of custom parts like injection molded parts? Although not critical to the performance of the device, it might be critical to the device success.

Have a development plan or a scalability plan. Understand your critical and key vendors once you’ve launched manufacturing and are working on commercialization and optimization of your product. It’s important to know the capacity or capabilities of not only critical vendors, but key vendors early on. This is especially true for vendors that you’re financially or technologically locked into working with because they hold IP. Understand their capabilities to scale with you early in the project to optimize your relationship.

Post Transfer Evaluation – Gather feedback from stakeholders, evaluate key performance indicators, and implement lessons learned for future transfers or manufacturing projects. Check for notes added during the course of Phase 2 and update. Improvements, no matter how small, become significant when added up.

Supply Chain

Supply chain materials planning is important during the transfer phase to build a foundation for procurement. A structured BOM directs the production team on assembly priorities and identifies critical parts.

Put a quality plan in place for critical parts related to safety and efficacy of the device.

Include consumables on the BOMs for easier control of the volumes and ordering of those parts. Consumables include stock labels, cable ties, etc. and are sometimes volumetric (for example, a thermal paste). Having all consumables on the BOM allows for better manufacturing controls.

Work closely with suppliers to make sure you understand whether your device design in the next phase, even in manufacturing, is going to be supported by their new products.

Inventory

Understand materials handling requirements up front to prevent material loss. If material comes through the door and a shipper receiver doesn’t understand how to handle it, damage may occur resulting in a shortage. This is also important for biohazardous material health and safety.

Have a strategy for stocking parts. Include nuances like regional versus local, inventory levels, and replace versus repair servicing.

Define inventory and storage conditions and controls. For example, highly optically sensitive tubes must be stored level so they don’t rub each other as that can impact their optical sensitivity. When building these parts, the bin should be in a clean room and stored to ensure overall cleanliness of the assembly.

Check your store! Sometimes parts have limited supply or, worse, become obsolete. Stay up-to-date and make sure you don’t get caught off guard. Keep it rolling!

Establish part yields. In some cases, it’s cheaper to accept a yield loss than to give feedback to the supplier and try to perfect the process. Figure out where you can get additional cost savings and where it’s more efficient to spend time on cost savings. This is particularly important in low volume items.

Quality Control

Test devices thoroughly. What happens when put the device into a different voltage as a localization? What happens if a non recommended power bar is used? Conduct as much QC testing as possible before release. Once devices are released, make sure they can be located, so they can be retrieved if problems are discovered.

Efficiently log any uniqueness of a particular unit. When something goes wrong in the field, it is important to understand if anything is different about the specific unit. Avoid tying yourself in knots with NCRs or other normal documentation protocols. A unit may meet all the requirements to go out in the field but something unexpected may happen. It is important to be able to flag that information for future units which have the same issue and help service engineers trying to troubleshoot in the field understand where to pay attention.

When building an optical device, build it in a clean room, shell out the extra money. If you look for defects in optics, you will find them.

Understand scratch and dig specifications. You can spend a lot of labor and alienate suppliers by not applying scratch and dig correctly.  They are a proxy for a quality metric as much as anything performance related. Be disciplined about understanding what will and won’t impact the optical performance of your device.

Assembly

Keep the assembly site safe. Clean and tidy up day in and day out. Maintain tools and keep equipment calibrated.

Use gap analysis to look at the existing process and determine if it is scalable to produce in larger volumes within a reasonable time frame. Things to consider are what is the likely reject rate? What is the yield?

A test or assembly step that works when the Engineer performs it because they can adjust and create a unique solution to make it work is very difficult to make work in manufacturing. It requires a deep knowledge of the device that is difficult to duplicate across the entire assembly team. The process is not capable, producing a lot of scrap and rework that makes the device not commercially viable. This is a common trap for early transfer projects as prototypes built by the engineer function giving a false sense of maturity that the device is ready for manufacturing.

Conduct drills or simulated builds before going for Pre-Production Units (PPU) builds. PPU requires documenting everything. Note the level of any deviations and errors made during the PPU builds. A drill will give you an idea of how things move physically on the floor, and whether you need extra storage bins for handling the materials. It also gives an overall picture of the assemblies, the final assembly and shipping. It opens windows for improvements, so you do not need to go back and add details to work instructions and documentation later.

Don’t lose sight of the commercialization process after transfer to manufacturing. Initial volumes are usually very low. The process of Design for Manufacturing (DFM) doesn’t stop. It’s an optimization of manufacturing, especially in the early stages of post-release into manufacturing, because we don’t know what we don’t know until we start getting into volumes. These little things can be incrementally improved. Like the lean startup process it is a constant cycle, a constant PDCA cycle. That continues throughout volume as well, but it is especially important in early manufacturing.

Sometimes things overlooked either in the design or in the transfer phases, can become big bottlenecks in manufacturing. Take, for example, Loctite loaded screws. If a certain amount of Loctite on a screw must be applied for an assembly, it adds assembly time. Instead, buy them patched so you don’t have to apply Loctite.

Service and Support

Once units are in the field, requests for field support service will begin. Don’t use top R&D engineers flying around all over the place, getting frustrated because that’s not what they signed up for and often not doing a great job. Many new companies get caught up in this situation.

When the device goes out to the field, that’s when the rubber hits the road. You don’t want your device to fail in the field. Make sure you’ve done all the end of line testing that you can. Try to anticipate what your end user is going to do to and try to prevent them from doing it incorrectly. Define all your use cases and what happens when it does break down the field. Have a game plan for that.

Make sure the devices have great traceability and you can find where they are. Are they at the distributor, the clinic? Be able to find where devices are quickly.

Working with Contract Manufacturers (CM)

Making one of something work is a difficult process. Making a thousand exactly the same is an equally different, difficult process. It can take longer to perfect that process than the development time. Just because you’re done with the design doesn’t mean you’re done and into production.  A lot of clients have done the first part, but they don’t realize how much effort is still left to get the second part done.

A gap analysis should always be conducted by your manufacturer to assess the readiness of your device. If it is not ready for manufacture, they can explain the minimum needed to get you to readiness. There should be a back and forth on how you’re going to move forward.  If you are new to transfers, reach out to a hybrid design and manufacturing company (like StarFish) to conduct a gap analysis. They will give you a really good idea of whether you are in the right ballpark to start manufacturing.

Involve your CM in development as early as you can. They will have tips on how to put the device together, how to improve assembly, how to improve manufacturability.

Client milestones should guide the contract manufacturer. For example, is a ramp up plan tied to part of your business plan, funding plans or possible future commercialization plans?  Your manufacturer should understand how much they should do (spend) to meet your milestone(s). Client milestones should guide what they focus on to deliver the best results for you.

Work with your CM to understand their capabilities so you can create a process together by which all your parts come off the line and meet the design specs. They will need to know your criteria to determine whether a unit is a good unit or a bad unit. Passing that knowledge on to a CM so that everything that comes off the line is a good unit, is a key part of design transfer.

When you’re planning to go to transfer and production, make sure to include additional development in your timeline and budget.