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In the year ahead, we’ll feature orthopedic suppliers with advanced capabilities that enable OEMs to create and launch differentiated products.
Here, ECA Medical, Lincotek Medical and Cretex Medical | QTS discuss Design for Manufacturing (DFM) services and the ways they partner with OEMs to speed time to market, as well as the real-life benefits that DFM brings to device development projects.
ECA Medical
James Schultz, Vice President of Sales and Marketing
OEM Collaboration. We like to get involved as early as possible in a project and are typically the manufacturer of record for commercial products, owning the Design History File, IOVV and all product and process validations. We partner with OEMs to create optimized and tailored instruments and sterile packs, surgery-ready kit solutions and provide economic value to the surgeon, O.R. team and patient.
As clinical and materials experts, including polymers, we support the design and development of legacy and new standalone instruments to complete procedural kits for the full range of orthopedic surgeries, including trauma, upper and lower extremities, sports medicine, spine, CMF and large joints.
Guiding the Process. During the concept or initial development stage of a project, we hold labs, cadaveric studies and sawbones training with our OEM customers and key surgeons to dial in the right configuration, process flow and stack up tolerances to meet functional, ergonomic and economic targets. During this phase, we prove out unique material selections and demonstrate that the product meets requirements with the necessary design margins and use cases to reach a design-stable level.
Our single-use, sterile and surgery-ready solutions must meet the rigorous demands of the intended procedure. Most importantly, they must be optimized and tailored, designed to meet demanding requirements at a price point that the market will bear.
DFM is critical because we want to ensure efficient and streamlined manufacturing steps to make thousands to tens of thousands of sterile instruments and surgery-ready instruments or kits per production run.
Prototype to Production. Design iterations and product innovation are infused in our four-step development process: concept and prototypes; voice of customer labs and design stable/freeze; verification and validations, including final multi-surgeon labs, reports and documentation; and design transfer and production.
Often, we engage at the feasibility stage of a customer’s implant concept and create options and recommendations for the best instrument set configuration for prep and fixation. We focus on developing instrument and kit prototypes of various types and materials — including 3D-printed, metal injected molded machined and molded components — to arrive at a solution that will differentiate our customers’ products and procedures from the competition.
Rapid Iteration. We do the heavy lifting and have a large library of “standard” products that allow customers to adopt them in their kits. This accelerates time to market and reduces development costs, including validations.
There are a lot of commonalities in instrument sets across various surgeries and indications. We can leverage our decades of work and expertise to significantly reduce time and cost and deliver complete sterile kits to market with all packaging, labels, validations and customer-specific branding within six months from the start of a project.
Proven Results. One case involved the optimized design of a single-use inserter for an absorbable intramedullary nail designed for hand/wrist and foot/ankle trauma surgeries. Using Finite Element Analysis software, we developed a 100% polymer solution with a design margin that not only reduced cost but also allowed for simpler manufacturing steps and kitting of the final product.
Another example involved a full suite of instrumentation for sacral joint implant prep and fixation surgery. The instrumentation design needed to withstand significant stresses and loads, including mallet strikes to drive a working channel and inserters to the joint area. We designed and developed hybrid instrumentation that combined stainless steel and polymer materials to achieve the necessary robustness and cost targets in a minimally sized sterile pack footprint.
Lincotek Medical
Troy Walters, Product Development Director
OEM Collaboration. Engagement for concept and feasibility varies, depending on the specific project and customer’s needs. Some projects come to us as early-stage ideas that must be developed into viable concepts and functional prototypes. Others arrive as working prototypes that require refinement, such as improvements for manufacturability, mechanical robustness or ease of clinical use. Our experience enables us to effectively support projects at any stage of development.
Guiding the Process. Our team asks a series of key questions to guide the product development process: What is the intended use? What are the mechanical requirements? What production volume is anticipated? Is there a target cost of goods sold?
We take the time to understand our customers and their answers, and align them with the customer’s broader market strategy — such as whether additive manufacturing is a priority — to facilitate the appropriate selection of processes, materials and cost structure.
Prototype to Production. It’s important to recognize that nearly any design can be produced as one or two prototypes. However, that does not mean the design is scalable for production, particularly when cost considerations are involved. Understanding the intended production volume is therefore critical.
For high-volume applications, can the parts be molded or cast? For low-volume needs, can the parts still leverage existing, validated processes? A diverse manufacturing portfolio enables our team to quickly and efficiently align each product with the most appropriate manufacturing strategy.
Rapid Iteration. There are several ways to manage rapid design iterations, depending on the product type, including using additively manufactured parts even when the final production process will not be additive. They also include developing multiple design prototypes, in which two or more concepts are prototyped in a single development cycle as parallel paths, helping to shorten overall development timelines.
Proven Results. We routinely see meaningful product improvements through DFM efforts. In one case, a simple change of adding or modifying a few radii on a milled spine spacer enabled the use of standard tooling instead of complex 3D contouring. This adjustment alone reduced machining time by nearly fifteen minutes per part.
In another case, a DFM review of a knee implant identified an opportunity to replace multiple tight-tolerance features with a single, datum-driven feature. By consolidating these requirements, the number of machining setups and inspection steps was reduced.
This simplification shortened production lead times, improved quality and allowed the product to move into validation and production more quickly without compromising performance or quality.
Cretex Medical | QTS
Ethan Meyers, NPI Manager
OEM Collaboration. We believe packaging development starts with thoroughly understanding the OEM’s goals and intentions for the project. Packaging design decisions can have a major impact on time to market, overall cost and end-users’ experience.
Our team can achieve our customers’ goals more effectively when we spend time to understand the device’s intended use and use environment, the OEM’s project goals, their sterile packaging strategy and where they are at in the design process when they engage with us.
The types of design inputs that we provide vary based on the needs of the project. In some cases, we are brought in early and consult with customers on their entire sourcing strategy, from component suppliers to package design assistance and which sterilization modality to use.
Other projects come to us fully specified, and we simply ensure manufacturability through our processes. We must listen to customers early on so we can understand their needs and goals and how we can best help them.
Guiding the Process. Decisions around manufacturing processes and package material selection also need to be heavily driven by an understanding of the OEM’s goals. For example, if a customer’s priority is to adopt new SKUs or alternate component suppliers to their product line in the future, then including a validated final cleaning process at our facility may simplify their overall cleaning and sterilization validation plan.
When reviewing package materials, we always look at what validations are available to leverage. OEMs can sometimes benefit from using our pre-validated packaging system for sealing and real-time aging. Other times, the best solution may be material on which the customer has already performed their own validations.
With a lower-volume project, we may be able to leverage our stock package program to avoid the high costs of low-volume package material runs, while improving speed to market. On higher-volume projects, the downstream cost savings of optimized custom packaging might outweigh the up-front investment.
Prototype to Production. Bringing a sterile packaged medical device to market is a significant endeavor, and extensive testing is usually required between prototyping and production.
Different devices have different testing requirements, both for end-of-line process validations (cleaning, packaging, sterilization) and in terms of device bench testing, clinical studies and useability evaluations.
Our project managers work closely with OEMs to manage this testing during the new product introduction process. We understand the exact level of production each sample needs to be at for each test. Then we work with suppliers to identify opportunities to accelerate timelines by making use of their pre-production or first-off samples when appropriate for a given test.
Rapid Iteration. Sacrificing traceability is not an option in our system. We only use inventoried and traceable components, including during test sample builds. Because we are very familiar with the need to move quickly and use pre-production samples during NPI, we created a process to get “engineering test sample” materials into inventory quickly with internally generated documentation.
We also ensure absolute segregation from production-level parts. This allows every material used on any test sample build to be traced the same way as in production. Every material used is always tracked by lot number in our ERP system, and the lot number leads back to a receiving document. This ensures that even when multiple items on the Bill of Materials are in a pre-production state and are rapidly changing, we can always trace exactly which version of a given material was used for any test sample build.
Proven Results. We worked with one customer to re-design the packaging for a gauze product that was similar to fiberglass insulation. Their predicate end-of-line process was to cut the gauze, scoop it with a spatula into trays, put a retainer on the tray to secure the gauze, load the tray into a pouch and seal it.
We redesigned the process flow and the packaging. By designing a backer card that could also be used as the tool for loading the product and designing a custom pouch that would hold the product and backer card with exactly the right amount of retention, we were able to validate a 10-pack that had a similar packaging footprint as a single unit of the customer’s original design. This dramatically reduced material, labor, shipping and sterilization costs, while enabling us to build in scalability by design.
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