Maximizing Efficiency and Quality: The Meddux Approach to Design for Manufacturability and Critical Parameter Management

Maximizing Efficiency and Quality: The Meddux Approach to Design for Manufacturability and Critical Parameter Management

Navigating the complexities of medical device development requires a delicate balance of efficiency and optimizing quality. At Meddux, we’ve implemented novel approaches to Design for Manufacturability (DFM) and Critical Parameter Management (CPM) to meet these demands head-on. Join us as we dive into how these methodologies underpin our ability to deliver exceptional products at every stage of the development journey.

Understanding Design for Manufacturability

Design for Manufacturability (DFM) is at the core of our strategy for developing cutting-edge medical devices. It’s not just a technical concept; it’s a crucial aspect of our overall business strategy. DFM encompasses a range of objectives, including cost reduction, increased throughput, supply-chain efficiency, and improvements in quality and yield. These objectives are carefully weighed against limited resources, such as time and capital, to ensure that the overall business case is supported and profit margins are achievable.

DFM is pivotal in identifying and addressing potential manufacturing challenges early in the design phase. Making informed decisions based on a clear DFM strategy is essential, as choices to support a minimum viable product (MVP) for clinical trials or pre-market launch can have long-term implications. For instance, initially opting for a less expensive manufacturing process may defer upfront capital investment in tooling and save time on the critical path. However, it could result in suboptimal process capability and quality, locking the company into a higher cost structure that requires substantial redesign to achieve commercial goals.

Balancing upfront costs with long-term benefits is a critical consideration in DFM. While it may seem tempting to prioritize short-term savings, investing in more expensive manufacturing processes initially can lead to greater scalability and competitiveness in the market over time. Therefore, having a well-defined DFM strategy from the outset is critical for guiding decision-making and ensuring alignment with overall business objectives.

The Meddux Approach to DFM Opportunity Analysis

At Meddux, we’ve developed a systematic approach to DFM opportunity analysis that ensures we maximize the impact of our efforts while working within the constraints of time and resources. Our team of seasoned industry experts is adept at conducting comprehensive analyses of existing products, pinpointing areas that can be most impactful to desired goals. We understand the importance of prioritization, focusing on opportunities that align closely with your objectives and the overall product lifecycle. This includes identifying inflection points in the projected market growth of your product, allowing us to time investments in new tooling and capital appropriately.

So, how do we go about identifying and addressing these manufacturing opportunities? It all starts with an in-depth analysis of various product attributes. We dive into opportunities for material cost reduction, pinpoint supply-chain constraints, optimize or change manufacturing processes, implement design for assembly principles, focus on scrap reduction, and embrace lean manufacturing practices. Depending on the priorities, we may focus attention on design changes for performance improvements or even conduct Kano analysis to ensure that the feature set aligns optimally with users’ needs relative to cost.

Through this comprehensive analysis, we identify opportunities for optimization that serve as the foundation for our improvement initiatives. We recognize that time and money are finite resources, so we prioritize our efforts accordingly. For instance, we understand that a significant portion of material costs is typically associated with a small percentage of components (the Pareto Principle, or “the 80/20 rule”). By focusing on these high-impact areas first, we can achieve meaningful results efficiently, ensuring that every investment yields maximum value for our clients.

Meddux Design for Manufacturability

Strategies for Design for Manufacturability

Meddux employs a rigorous DMAIC approach (Define, Measure, Analyze, Improve, Control) to implement DFM strategies. This structured methodology ensures that the objectives are clearly defined right from the outset of the design phase. We understand the importance of accurate early estimates for cost, assembly time, and process variability, which are benchmarks to verify and refine throughout the development process. Our ultimate goal is to achieve consistent cost and quality, explicitly targeting low process variability in steady-state production and across the supply chain.

Let’s explore some examples of DFM strategies and their impact on product quality and efficiency. One common example is the approach to plastic injection mold tooling. Many clients are tempted to defer costs and schedule impacts by opting for 3D printing or low-cost rapid prototype mold tooling. While these options offer the lowest upfront cost and maximum flexibility, they come with limitations in terms of materials, biocompatibility, sterilization compatibility, and process capability. Additionally, the piece part price often exceeds what is acceptable for the product’s Cost of Goods Sold (COGS).

In light of these considerations, we often advise clients to consider MUD base tooling as an alternative. This option strikes a balance between cost-effectiveness and durability, featuring lower cost/lead time and allowing for the use of tool steel core and cavity inserts. This approach enables access to a wider range of engineering thermoplastics, advanced gating options, and ongoing process control. As the product scales to higher volumes, transitioning to high-volume molds with multiple cavitations becomes increasingly viable, reducing piece-part costs and improving manufacturing margins.

Ultimately, the choice between different tooling options hinges on factors such as the stage in the product lifecycle and expectations for cost and quality. By carefully considering these factors and implementing DFM strategies tailored to each project’s unique requirements, we ensure that our clients achieve optimal outcomes in terms of efficiency and product quality.

Understanding Critical Parameter Management (CPM)

CPM is a cornerstone of our approach at Meddux. It ensures that manufacturing processes remain in a controlled state to guarantee product quality and performance. We utilize a systems engineering approach, starting with identifying Critical Functional Requirements (CFRs) that directly impact device safety and performance. We then identify and link Critical-to-Function (CTF) attributes from a top-down perspective. The overall objective is to implement robust manufacturing process controls that ensure consistency across various levels, including system, subsystem, component, and manufacturing process.

At Meddux, we have developed a comprehensive approach and concise documentation that trace these high-level requirements to ongoing quality controls in manufacturing. This documentation is a lifecycle management tool, delineating requirements for component inspection, process validation, test method validation, and component qualification throughout the manufacturing process and supply chain. Every step of the way, our approach is risk-driven and tailored to the specific needs of each project and customer.

CPM is an essential part of our quality assurance efforts, ensuring that critical parameters are meticulously managed throughout the product lifecycle. By implementing rigorous controls and traceability mechanisms, we uphold the highest standards of quality and reliability in every device we manufacture.

Critical Parameter Management

The Meddux Approach to the CPM Process

Our CPM process identifies, controls, and monitors critical parameters throughout the manufacturing journey. Critical Functional Requirements are central to this process, which are essential design parameters derived directly from Design Inputs and Risk Management. However, we focus solely on the “critical few” to ensure that our resources are directed where they matter most.

Once CFRs are established, we cross-reference them for interactions at the sub-assembly and component levels. If a sub-assembly or component is strongly associated with a CFR, one or more Critical-to-Function (CTF) parameters are identified. These parameters become the focal point for our engineering resources early in the design phase. We conduct additional analyses and evaluations to ensure a robust design, such as tolerance stacks, computational analysis (FEA), and reliability stress tests (HALT/HASS).

As we progress through the development phase, these same CTF parameters guide us in defining inspection criteria, test method development, and validation strategies. We statistically sample process capability in early production stages to baseline the CTF parameters. Based on the Cpk sampling results, we select an appropriate process control strategy to improve or maintain process consistency.

This systematic approach allows us to be explicit with our suppliers regarding process validation and component qualification requirements. By continually monitoring and controlling critical parameters throughout the manufacturing process, we ensure that every device we produce meets the highest standards of quality and reliability.

Integration of DFM and CPM at Meddux

We recognize the intrinsic link between DFM and CPM and understand that optimizing design and manufacturing processes requires a cohesive approach. While DFM and CPM are distinct efforts, they are deeply interconnected in our methodology.

Incorporating CPM principles into the design phase is integral to our DFM strategy. Tolerance limits established through the CPM process are precisely defined and embedded into the design, ensuring that manufacturing processes can achieve the desired consistency within specification tolerances. It’s crucial to strike the right balance here; over-constraining the design can have detrimental effects on cost and yield. Every DFM decision we make involves a series of trade-offs and compromises aimed at achieving the desired cost, quality, and throughput objectives.

Integrating DFM and CPM at Meddux is about harnessing the collective power of design and manufacturing to deliver superior products to market faster and more efficiently. We stay at the forefront of innovation by aligning these efforts and leveraging their synergies while maintaining our commitment to excellence.

Benefits of the Meddux DFM and CPM Approach

With decades of experience bringing innovative products to market, we understand the pitfalls many programs face during the transition from early market entry to steady-state commercial production. Our expertise in applying the CPM process allows us to focus on what matters most from the outset, making intentional and targeted decisions that positively impact DFM throughout the product lifecycle.

Quality, Cost, and Schedule are always a trade-off decision. If you have ever heard the mantra “Quality, Cost, Schedule – pick two,” it is a very appropriate statement. The key is to understand your objectives and be uncompromising on what is essential. Everything else is a trade-off decision. Quality, by definition, is about compliance, conformance, and the reduction of variability. At Meddux, we put a lot of emphasis on the latter, and this keen focus on process variability drives everything else.

Our approach improves overall product quality and results in substantial cost savings. We achieve this by identifying and addressing manufacturing challenges in the design phase itself, which helps streamline production processes and minimize rework. By doing so, we minimize manufacturing costs, enabling our clients to maximize their return on investment.

Another key advantage of our DFM and CPM approach is accelerated time-to-market. By optimizing both design and manufacturing processes, we minimize delays and ensure that products reach the market faster. This competitive advantage is invaluable in today’s fast-paced business environment, allowing our clients to capitalize on emerging opportunities and stay ahead of the competition.

Conclusion

The importance of a DFM strategy at the outset of any design endeavor cannot be overstated. It is fundamental for success, setting the stage for a robust product design that can be scaled while concurrently achieving business objectives for cost and quality. By integrating best practices such as CPM, organizations can ensure that their products meet and exceed performance expectations.

Our expertise in these areas enables us to drive innovation and deliver superior outcomes for our clients. Moreover, we’ve seen firsthand the transformative impact that engaging with and independently reviewing existing designs can have. By focusing limited resources on what matters most and laying out a strategy for success, we help teams confidently navigate the complexities of product development.

With DFM and CPM as guiding principles, we take a holistic approach to the entire product lifecycle, supporting our clients from market launch to maturity. By leveraging our expertise and proven methodologies, we empower organizations to overcome challenges, seize opportunities, and ultimately achieve their goals in the dynamic landscape of medical device development.

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