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Orthopedic devices are highly engineered marvels that restore mobility and improve the lives of millions of people each year. The journey from concept to realization is no easy accomplishment, oftentimes taking years to go from concept to market. At the heart of this journey is the iterative process of design optimization for manufacturability, where getting it wrong can significantly impact realization with delays, excessive costs, or worse, a device that may never reach the patient.
One of the most effective ways to achieve such optimization is through a collaborative relationship with a contract manufacturing partner (CMP). More than just manufacturers, CMPs are strategic collaborators who bring decades of experience to use at your disposal. Partnering early in the design phase, orthopedic device engineers will find their concepts avoid pitfalls and can be produced more efficiently and cost effectively, providing benefits to both organizations.
Let’s explore the benefits of working with a CMP and provide insight into the process of optimizing device design through this unique partnership.
Framing Your Relationship as a Partnership
The relationship between a medical device OEM and a contract manufacturer should extend beyond a mere transactional exchange. While the print submission/quote/purchase order approach can work for legacy products without further input or interaction, this approach has the potential to cause strain and friction between a supplier and customer. Oftentimes, it can lead to disappointing results when working on a new product launch.
Framing the relationship with your contract manufacturer as a partnership taps into the real value that can be provided throughout your entire development process. A partnership mindset allows for an open dialogue that supports and encourages access to a full range of specialized processes. Leveraging a CMP’s expertise in manufacturing complex devices can facilitate optimized production workflows that result in successfully navigated project timelines to meet key milestones.
One of the additional benefits of working with CMPs is their ability to offer a fresh perspective on device designs, which is rooted in their deep industry knowledge. Their experience of working with a diverse range of projects with other medical device OEMs allows them to bring innovative solutions and best practices to the table—all for the benefit of your product.
The Collaborative Manufacturing Approach
When establishing your product’s project timeline, the earlier the collaboration process starts with your partner, the more impactful the relationship can be to your overall timeline. Evaluate your relationship with your selected partner and lay out a framework for your project with the following considerations.
• Consistent, Clear, and Timely Dialogue—Communication is at the heart of a dependable relationship. Establishing a baseline of consistent and unambiguous dialogue between organizations provides an alignment of stakeholders, sets expectations, and ensures each side’s input is valued. Maintaining regular communication with specific feedback loops is crucial for identifying and addressing challenges and incorporating respective solutions. The timeliness of communication is something that cannot be overemphasized. Getting the necessary information out in the open allows both teams to proactively collaborate on a resolution.
• Cross-Functional Teams—For more efficient communications, try pairing members from respective functions across both organizations. Representatives should include members from areas such as engineering, manufacturing, and quality. Involving project champions from the management team ensures both the visibility and legitimacy of the project’s direction are understood.
• Manufacturing Capability Identification—Each project will have its own unique needs and challenges. These will require the appropriate manufacturing capabilities identified to bring your product to fruition. Your CMP can provide you with an understanding of how each of the processes required impacts your product’s manufacturability, quality, and timing. Consider those with vertically integrated processes as they can more effectively control quality and timelines.
• Manufacturing Capacity Allocation—For large-scale projects with tight deadlines, securing capacity is, perhaps, the most crucial component of a successful product launch. Identifying these constraints early on with the help of your CMP provides an opportunity to mitigate the risk and opens the possibility of investment in new capacity resources or alternatives. CMPs with multiple sites and capacity structures can provide the unique option of expanding capacity within their internal network.
• Collaborative Workshops—In-person visits to your CMP make it possible for members from both teams to conduct brainstorming and problem-solving sessions. These visits can provide both organizations with a chance to exchange ideas and explore effective solutions. Print and process reviews while concurrently walking the team through the process on the floor can bring to light both issues and opportunities.
The Design Optimization Process
Design optimization is a critical phase in the development process. This involves refining and improving device designs to enhance their performance, manufacturability, and cost-efficiency. Engagement with your CMP in the early stages of development, particularly before the design has been finalized, has a tremendous return on the time invested. Bringing in a CMP’s perspective during the design optimization phase helps focus your combined efforts on fine-tuning your product. It is a mutually beneficial relationship as your partner’s feedback bridges the gap between engineering objectives and manufacturing reality, ensuring designs can be both innovative and feasible. To effectively leverage your partner’s expertise, consider some of the following enhancing elements.
Design for Manufacturability
Design for manufacturability (DFM) is essential in optimizing orthopedic device designs, as the purpose is to ensure devices can be manufactured in an efficient and cost-effective manner. These DFM principles consider matching the appropriate process with each feature of your product with the goal of ensuring repeatability and manufacturing efficiency, ultimately keeping timelines and costs in check.
Your CMP can offer valuable insights and expertise in identifying potential manufacturing challenges and proposing solutions that maintain your design’s functionality while increasing manufacturability.
Additionally, while it is one thing to have the capability to manufacture a part or specific feature, it is another to know it was made accurately and within specification. Selecting the appropriate inspection method is just as important as the selection of the manufacturing method. Your CMP can guide you to inspection methods that best suit each feature, whether it be variable hand measurements, CMM inspection, or feature-specific gaging. Confidence is best gained through the assurance each part meets requirements.
Process Development and Prototyping
A priority should be made to add process development and iterative prototyping to your project timeline. This is particularly important when pushing the envelope of manufacturing capabilities. While DFM efforts help reduce or minimize the unknowns in manufacturing, it is still wise to ensure the selected processes produce the required results. Process development coupons or analogs should be completed before moving to your validation phase, where the design is frozen and changes can be more difficult to implement.
Post-Production Support and Continuous Improvement
Once your product is launched, the opportunities for improvement are not over. The partnership with your manufacturer extends beyond just the initial design, manufacturing, and launch phases outlined above. In fact, ongoing post-production support and continuous improvement efforts are the hallmark of a partnership that is built on trust and cooperation.
Evaluate Your Process or Partnership Opportunities
Adopting a collaborative approach with contract manufacturing partners is fundamental to enhancing the efficiency of product launches for orthopedic devices. Encouraging and fostering this partnership mindset will unlock the full potential CMPs have to offer.
As you reflect on your current design process, consider how early and consistent engagement with your CMP can bring invaluable insights into your projects. Evaluate whether your existing partners are providing the comprehensive manufacturing capabilities and capacity needed to support your product launch. If you find your current partners are falling short, it may be time to seek out a CMP with a proven track record of delivering high-quality, cost-effective solutions and the ability to scale capacity as needed.
Take action to assess and optimize your design process and explore ways to leverage your relationship with your CMP to achieve successful product launches. The right partner can make all the difference in bringing innovative orthopedic devices to market efficiently and effectively, ultimately improving patient outcomes and driving business success.
Chad Ryshkus has over 20 years of experience in engineering and commercial roles within the contract manufacturing space for medical devices, particularly in the orthopedic and spine markets. He combines technical expertise with a strategic mindset to achieve commercial success for his customer-partners.
