Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three Manufacturing. This article covers Phase Two Medical Device Transfer to Manufacturing tips and examples from our employee experts.

Solid Foundation Required

For Phase Two Medical Device Transfer to Manufacturing to go well, Phase One also needs to have gone well. If you end up in Phase Two and fundamental things aren’t compatible with the expected volumes or the manufacturing technologies needed for launch, it likely means these areas did not get addressed properly during the design cycle.

A strategic decision could be to not address certain areas earlier to save money early on. If you must revisit those areas closer to transfer, it will be more expensive and more time consuming,

Allow time for process development. Process development is a phase and a requirement for a smooth transfer. Otherwise, you will try to iron out the bugs after transfer, which is always more costly.

Before transfer, a manufacturing engineer should become part of the design team making the decisions with you. When the time comes for a transfer, they have been part of building the product from its earlier phase. That makes the transition to Phase Two much easier.

Documentation should be done as you’re working and iterating on the device. A manufacturing engineer can begin understanding resource allocations and shelf space needs and start putting that data into the manufacturing system. They will also understand whether the product will need extra manufacturing resources.

Training a manufacturing tech can be arduous, especially for a complex device, but if they’ve seen prototype builds several times and gone through iterations with hands on experience in the design phase, transfer becomes very easy.

Make sure everyone is on the same page. Share the information to stakeholders and the handover acknowledged. A design transfer is something like a floodgate. The team is trying to mitigate all the concerns that might happen in the manufacturing during the design transfer.

Keep drawing updates and minor revisions in your device master record (DMR). You will want to do multiple rounds of implementation. Leave some agility in the ability to update your documents and time to implement those changes before each round of builds. Using old documents or references isn’t going to help your progress.

How to build?

Clearly defined Assembly/Test Procedure and Work Instruction documents are your best friends. Capture as many details as possible, even if it seems obvious.

The more photos, the better! Photograph builds in phase two. Especially with cell phones, it’s easy and saves a lot of time.

Document what you’ve done instead of having to go back and build a dummy device to write work instructions later.  Record how long it takes you to build it.

Have a standard Medical Device Transfer to Manufacturing checklist to help your team check and meet deliverables in the order needed.  Maintaining a checklist helps reduce some repetitive day-to-day work. For example, in design transfer it’s easy to repeat things like documentation. Different groups are working on different things like software, electrical, mechanical, etc. Updates to the DMR, where different groups are working on the same documentation, might require releasing the same documentation many times repeating the work.

Iterative change and not jumping into major revisions are important. Make room for agility during Phase Two Transfer. Map details to the device master record (DMR), but don’t rush into a major release of the DMR. There’s a lot of value in minor revision validation builds to update the DMR before freezes. Taking time to slow down and conduct iterative reviews can result in a faster timeline reduced workload.

The first part for design transfer is design tweaks. Do not start the design transfer until there is a design freeze.  Once you start design transfer, check, and confirm suppliers can produce the parts in large quantities, are able to handle the packaging and shipping requirements for large quantities, and can provide the certificate of conformity, or CoC, and other requirements that are important for each project.

Supply Chain

What’s important for the supply chain during Medical Device Transfer to Manufacturing? You should have a formal BOM with all the part numbers, manufacturing part numbers. The custom parts should be defined. The suppliers should be evaluated before the transfer to confirm they have the capability to be the manufacturer for manufacturing.

The supply chain team will need time to work through the manufacturing vendor list.

Often vendors are chosen in development because they can get parts fast, even if they can’t get parts in high volume. Production vendors are the reverse. They need to get parts in high volume, but they often can’t get parts fast. Schedule time with production vendors to ensure that they can meet quality, timing, and volume requirements.

There are key parts and there are critical parts. Critical parts are parts that are related to safety and efficacy of the device. They are qualified against the third-party audits and internal QC tests. Have a quality plan that highlights this process. Evaluate suppliers’ capabilities based on your quality requirements.

Predict or forecast the number of devices to be manufactured before you start conversations with suppliers. Select suppliers and make agreements before starting the design transfer phase. Ideally, all the supplier evaluations and prototypes or builds will happen at an earlier stage (before Alpha Gate) or at completion of the design and design controls phase.

Between phase one and two, make sure your distribution channels for key off-the-shelf components are established and reliable. They may not be prepared to deliver larger quantities of the pieces that you need or may not be able to supply those pieces for a sufficiently long enough time. Engage your supply chain early.

Consider prototype molds for injection molding. Compare the initial run of your device and the total available market for your device. Sometimes a few thousand units are all that’s needed. You can avoid the cost a production mold for injection molding. For example, prototype optical molding for a very large medical device manufacturer was approved by their contract manufacturer and much cheaper than the layout for making production molds.

The nature of this step in medical devices is quite different than other industry standard practices. One of the primary reasons is because it isn’t known if products will have success until they’re out in the market.  Expectations for a medical device need to be honed down to what is critical. The first launch of the device needs to be out in a way that’s not overburdening.

A lot of time is spent on tooling. parts and establishing a manufacturing process that’s good enough to get a safe and effective device on the market. If it is exactly what people want, you ramp up production. Or you may need to have a fast follow release because the device is missing a significant section of the market due to missing functionality. Or it needs design changes in manufacturing because of findings from the product launch. This is often uncomfortable for people in manufacturing who like things to be baked and optimized, but it’s hyper critical for the medical device industry.

Large acquirers are interested in a scalable supply chain, particularly after Phase Two. Startup companies doing an early launch, typically want to launch a little soft.  Companies seeking a good exit price must be further along. How do you bridge from early manufacturing to optimizing exit value? Have a scalable supply chain in place that’s not going to fall over when they tackle their volumes, and you get a major discount. They must make allowances for spending a pile of money on inventory.

Logistics

Predefine the market placement for your product so you understand the regulatory and localization requirements. It’s very difficult to get compliance documents after you’ve already ordered your material for a transfer. Have the compliance documents or at least an understanding of the market that you’re trying to sell into before you buy your transfer material.

Think about translations. Often projects are delayed waiting on translations of labels or user guides. As an example, Brazil has some very specific requirements for labeling and for power cords that can cause a lot of delays when creating the localization kits for that country.

Don’t forget packaging! If you rush packaging in the transfer phase, crate design may suffer, costing more money in shipments. This is a very important design requirement.

“Do not underestimate labels”. The number of delays due to labels is just staggering. Not all countries are the same, and even though they might be in a particular union like the EU, there are still differences that you have to figure out. Often packaging, labeling and localization get left until the last and it can be time consuming and cause delays.

Consult your logistics team when designing your shipping materials and your crate to understand the size and weight envelopes for the different price ranges. This is not done for many projects, and it makes a huge difference in the shipping costs.

Think about your strategy for stocking parts. There are nuances about regional versus local, how much inventory to carry, etc. versus trying to repair.

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

When the device goes out to the field, the rubber hits the road. You don’t want a device to fail in the field. Conduct all the end of line testing that you can. Anticipate what the end user is going to do. Define all use cases and what should happen when the device breaks down the field? Have a game plan. Make sure devices have great traceability so they can be located quickly.

Log any uniqueness of a particular unit. When something goes wrong in the field, it is important to understand if anything’s different about that specific unit. but you can really tie yourself in knots with NCRs or other normal documentation protocols. A unit may meet all the requirements to go out in the field but if something unexpected happens it is important to be able to flag that information for future units which have the same issue. This helps service engineers to troubleshoot in the field and understand where to pay attention.

Servicing units and problem solving in the field are part of the DMR and very easy to forget. Field support service begins as soon as units are in the field. Avoid using top R&D engineers flying around getting frustrated because that’s not what they signed up for and are often not doing a great job. Many new companies get caught flat footed in this type of situation.

The sales team must understand what taxes are related to each Harmonized System (HS) tariff code that defines your device in other countries. These hidden costs are important to understand.

Where to build? The location must consider the quantity and frequency of manufacturing, not just the floor layout.

Consult your manufacturing arm early. Engineers can get focused on the details of how they’re going to solve the problem technically and lose sight of cycle time and yield and things that are important for production.

Look at flow requirements, resource requirements, and the number of people needed to determine and prioritize manufacturing needs. Forecasting feeds floor requirements for the level of clean air, continuous clean air power sources and all that should be addressed in terms of manufacturing or operation’s needs.

Understand the window for return on investment in manufacturing process changes. People will say you’ve got to optimize this, that or the other. But understanding the window for your return on investment in the additional engineering efforts is key.

Any sort of optimization of your manufacturing process is going to result in better margins. Figure that out before any sort of exit calculation.

Who will build? Train and certify the people who will put the pieces together and create your masterpiece and thousands of its duplicates, consistently. Treasure their feedback and improve.

When making design choices, engage with the people who are going to building the device because they will point out things the designer does not think about in terms of how to assemble things, where to put walls, and what makes sense from a manufacturability standpoint.

Design for assembly early in the process, and that means involving manufacturing. Designed for manufacture is one thing. Design for assembly is also a thing and it is equally important to get the experts involved.

Optimize for touch time to keep manufacturing as lean as possible. Figure out if an action or task in the manufacturing process is going to require a lot of touch time and then optimize and automate it as much as possible. Start with the largest touch time by talking with the manufacturing engineer to figure out which thing somebody’s going to have to fiddle with or sit on a computer and click 100 buttons for. Automate that first and then keep cutting it down until your costs meet budget requirements.

Determine how much work you should spend getting defects out of custom parts like injection molded parts. Setting expectations around production readiness may not be critical to device performance, but it might be critical to the device success.

Work with a design engineering partner that understands the transfer of medical devices to manufacturing. In other words, use a partner who understands the Medical Device Transfer to Manufacturing tips shared in this article and integrates them into their practice.