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September 25-27,2024 | SWEECC H1&H2

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Finished Medical Device Assembly—A Medtech Makers Q&A

The pandemic has caused many to re-examine processes and protocols they are engaged in as well as those performed by their service provider partners. While many are thrilled to be putting the challenges from this time behind them, they are carrying lessons learned forward to improve their overall performance and gain advantages not previously realized.

One such aspect that hadn’t always received the attention it should have was finished medical device assembly. This “end of the line” step can be optimized if considered early in the product development lifecycle. As such, gains can be achieved with regard to costs and time to market.

Speaking to the lessons learned from the pandemic, ways to improve the finished device assembly process, and important considerations to keep in mind is Carl Lider, chief operating officer at MRPC. In this Q&A, he offers insights on ways his company helps customers gain advantages during this step and what decisions they need to make before they arrive at it.

Sean Fenske: Looking at finished medical device assembly, what changes were created over the last two years due to the pandemic?

Carl Lider: MRPC reacted quickly to develop strategies as an essential business to meet the requirements of market demand, but our priority was for the safety of our teams. The FDA guidelines for manufacturers was the default resource, but we also sought practices within industry associations that supported our business continuity strategy. MRPC put emphasis on tools and technology for remote collaboration, skill depth and competency, production oversight, and optimization of cleanroom environmental systems.

As remote working increased and company travel curtailed, MRPC launched two enterprise systems that improved productivity. The first was cloud service for document collaboration integrated with video conferencing, and the second was a new enterprise resource planning system with online workflows and a manufacturing execution system (which included real time production and process monitoring). In addition, we added cameras to our access control system for remote process oversight.

Product mix changed at the onset of the pandemic from elective surgery products to those supporting testing and treatment of COVID-19. Following the onset, the market demand for product groups became unpredictable and supply chain challenges soon followed, leading MRPC to work with customers to streamline the requalification of processes with alternate materials. It is ideal to qualify critical, alternate materials up front, but this does require additional resources and customer support.

MRPC was able to navigate the supply chain process fairly efficiently. Having over 100 years in business allowed us to build up a list of valued suppliers. Access to multiple sources for the materials used to support our client initiatives was an extreme benefit in supporting their medical manufacturing needs during unprecedented times.

With some uncertainty of the workforce, a versatility matrix has been instrumental in creating depth and competency for essential production cells and low-density skillsets. This also led to job classifications supported by a pay-for-skills type of structure.

MRPC optimized air exchanges and positive pressure through the HEPA filters within our cleanrooms to reduce contaminants. We have employed sensors to monitor cleanroom parameters in real time and can now review data sets for trends.

Fenske: Are there best practices to be learned from these changes or were they temporary solutions for a challenging time?

Lider: Some practices are suited for future risk mitigation and, thus, documented within our business continuity plans. However, most of the practices complimented our manufacturing excellence journey and systems were institutionalized for all three of our locations.

That said, one of the learnings our clients took away from the pandemic was the importance of a total solutions partner. Our clients were able to contact us and quickly receive a complete picture of the status of their program, simplifying the supply chain.

Fenske: Are you seeing increased interest in automated solutions for finished medical device assembly? Lider: Yes, MRPC has ramped up its investment in automation and we continue to partner with new integrators. Time to launch automation has been longer due to integrator capacity, but primarily due to the lead time of critical components. Incorporating automation with new product introductions becomes part of the normal process; OEM support for resources can be a challenge where requalification is required.

For the low volume/high mix products, our strategy is to deploy small, modular, flexible, and re-deployable automation. For this reason, we have employed many cobots, which have smaller footprints and can safely function alongside the workforce. For high volume-low mix the automation solutions can be complex, but a focus remains on standardization for interchangeability of components and lower complexity to ease the learning curve in servicing the automation equipment.

Fenske: How does automation solutions compare and contrast with human labor? Lider: MRPC automation targets include monotonous, repetitive, and error prone tasks, but also where operator variation exists. On the other hand, we value skills that human team members can bring in, such as problem solving, training, deductive reasoning, and creative thinking.

Continued advancement has enabled MRPC to incorporate multiple technologies into our automation solutions. For example, MRPC has employed vision systems to prevent a suspect condition from being passed on to the next process. We will continue to seek to improve by leveraging technology to prevent making a suspect condition.

Fenske: Is there a benefit to working with a partner that can handle all aspects of the medical device manufacturing process, including assembly (e.g., a full-service manufacturing partner)?

Lider: Working with MRPC to achieve a complete finished medical device solution reduces complexity in the supply chain and reduces resources needed for supply chain oversight, such as audits and validation requirements. This process starts with the design for manufacturing process, which is integrated into our product introduction processes.

Once series production is achieved, speed and flexibility are a benefit of the combined value stream. MRPC optimizes value streams by using lean techniques to maximize flow and minimize waste. Where it makes sense for high mix, MRPC will employ a late-stage conversion process where common SKUs are maintained until it is determined what products are needed and when.

Overall, we focus on offering clients device assembly, packaging, and sterilization management of finished medical devices. As a result, our clients typically experience a shortened and simplified supply chain, reduced time to market, total control over the program, and improved quality of their medical devices.

Fenske: What aspects do medical device OEMs overlook or neglect to consider when it comes to finished assembly?

Lider: Solutions are often more successful if the OEM can provide a detailed scope of work and a design failure mode effects analysis at project inception. This allows the design for manufacturing process to achieve requirements and specifications, reduces the need for follow-up engineering change orders, and maintains a confident process of traceability. With MRPC’s manufacturing execution system, we can trace a finished assembly product’s serialized bar code to all major resources of the production process to include the specific lot of raw materials to the finished assembly.

Fenske: Do you have suggestions for finished medical device assembly when components are coming from different regions, some of which may be delayed? How is that handled?

Lider: Completing a comprehensive risk assessment of the supply chain allows the opportunity to mitigate risks. Categories such as performance to product quality or delivery performance are typical but recent events have placed emphasis on the magnitude and likelihood of occurrence of business disruptions to specific geographic locations. Manufacturing site location is a critical aspect in supplier selection. Other techniques such as employing stocking agreements can help mitigate risk for short-term interruptions, but may not be the best countermeasure if a known risk is evident.

Fenske: If working with a manufacturing partner (or multiple partners), do you have any suggestions for selecting the final assembly location? Is there a “best choice” as to where the process should take place?

Lider: There are certainly cost considerations, but continuity of supply is best served when there is less dependency on overseas shipments. MRPC follows this thought process, with the intent of three geographically dispersed manufacturing locations.

Another key aspect to consider is the literal location of the assembly process. The vast majority of our assembly processes take place in a controlled, certified cleanroom environment. This includes the molding, inspecting, assembling, testing, and packaging of the components. When the entire process is handled in the room, it eliminates the chance of outside contamination.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?

Lider: While finished medical device assembly may not be at the forefront when planning out a medical device component or device, thinking about it early in the process can positively impact your overall program. Improved quality, simplified supply chain, and minimized pitfalls and risks are a few of the benefits. These, in turn, can lead to reduced cost for your project and quicker time to market.

Article source: Medical Product Sourcing