When thinking about new product introductions (NPI), the phrase “two heads are better than one” comes to mind. Two designers are better than one when working on a new project. Expanding that out, two development teams are better than one. And bringing that out even further, two companies working on a new product are better than one. With NPI, this is the frame of mind all designers should have if they will be eventually working with a service provider partner.
When a medical device company designs a product solo and then reaches out to a manufacturing partner with which they plan to work, numerous advantages can be lost. By involving the partner early in the development process, the design can be optimized for specific materials and manufacturing protocols the company may want used. While the medical device OEM may be the expert on the clinical aspect of the device, the manufacturing partner is likely more of an expert on the creation of it.
To further espouse on the advantages that can be realized from bringing a manufacturing partner into the mix early in development of a new medical device are a pair of engineers from Paragon Medical. Justin Allsop is an engineering manager at the organization’s Smithfield, Utah location, and fellow engineering manager, Brandon Borgman, calls the Bloomingdale, Illinois facility home. In the following Q&A, they share their thoughts and insights on the importance of working with a service partner during NPI.
Sean Fenske: When it comes to working with a service provider, we always hear it’s important to get them involved early. Why is this so important?
Justin Allsop: We seek more than a “build to print” relationship with our customers. Successful manufacturing is so much about solving problems, and problems are usually best solved as close to their origin as possible. Countless different inputs and expertise must come together along the path of taking an idea or concept all the way to the patient. By partnering with our customers early, we can provide that manufacturing expertise as the design is in development to prevent and solve problems sooner rather than later. A part design that lines up well with its manufacturing process capabilities will run well on machines, have very high quality, and allow for predictable deliveries at a great value.
Brandon Borgman: Partnering early with our customers and discussing part and assembly features before chips are cut almost always allows us to suggest subtle changes that do not impact form, fit, or function, but can improve price and efficient delivery of the product. We often find that our customers’ design engineers are open and interested in making these subtle changes to make the overall product more manufacturable. At Paragon Medical, we have a diverse and experienced group of manufacturing and quality engineers who value the opportunity for early input to offer that experience to our customers when it matters most to ensure long-term success.
Fenske: With a new product introduction, at what point does the customer come to you? Is it with the “napkin sketch” or once they have a more concrete idea in mind? Does it matter?
Allsop: At Paragon Medical, we collaborate with customers at every stage of new product introduction. Our seasoned and committed NPI teams, equipped with effective processes, stand poised to partner with our customers at any point in their journey. Our dedicated program managers oversee multi-site opportunities, while site-specific project managers, quality engineers, manufacturing engineers, and programmers come together to form cross-functional teams. These teams are adept at addressing all facets of the project and product, ensuring a comprehensive and successful collaboration.
Borgman: Within Paragon Medical, we utilize Innovation Centers and prototype cells dedicated to product innovation, rapid prototyping, and process and equipment development to support our customers in the early stages of design. Developing prototypes in-house enables our multi-site teams the ability to seamlessly transition into production when needed, utilizing strategies and solutions from the prototyping process. Once we’re production ready, Paragon Medical is well-positioned to provide supply chain continuity through its ability to dual-source internally. Early involvement gives both our team and the customer room to maneuver in making changes, aligning drawings with manufacturing processes and inspection methods, acquiring raw materials, as well as capacity planning.
Fenske: When working with a service provider on an NPI project, what are some considerations orthopedic device OEMs fail to consider?
Allsop: It’s important to consider support after the launch of product. As a supplier builds out production post-launch, opportunities for improvements in the process often emerge. Depending upon the type of change, customer approval may be necessary through a Supplier Change Request process (SCR). It is then important for the OEM to have a rapid and robust process for handling these SCR requests, providing support, and delivering feedback as efficiently as possible. The time it takes to provide feedback on SCRs is an opportunity for improvement that can benefit both the OEMs and the suppliers. Lastly, I recommend aligning print tolerances with manufacturing capabilities and inspection methods. When these three items are aligned, predictable and efficient manufacturing results, which is good for both the OEM and supplier.
Borgman: More recently, we have found customers are surprised to learn that we offer additive manufacturing of titanium (and soon, cobalt chrome). This 3D-printing capability, combined with Paragon Medical’s ability to perform a comprehensive array of secondary operations, opens the door to manufacturing options that can give our customers a competitive edge that simply isn’t available from other manufacturing partners.
Fenske: Paragon Medical has been active of late with M&A, and anodizing services seem to have been of specific interest. How does this service capability fit into the equation for NPI projects and customers in general?
Allsop: We are excited about the addition of Industrial Anodizing Inc. (IAI) and Whimet Inc. to Paragon Medical. Both have been long-time suppliers to Paragon Medical and have a proven history of providing excellent service and support. IAI is located just a few miles away from the Paragon Medical Smithfield site and supplies both type II and type III titanium anodize. The Smithfield site has developed a close partnership with IAI as a result of our dedicated bone screw cell, which sends orders to IAI for titanium anodize every day. The partnership has now evolved to that of co-workers. The addition of IAI and Whimet will bring on the expertise of their staff and will benefit our customers in more efficient problem solving, lead times, and pricing for metal finishing activities.
Borgman: Outside services are often the uncontrollable element that can add uncertainty to estimated lead times and can sometimes result in less efficient delivery. By adding anodizing services to our comprehensive portfolio of capabilities, we can better control our priorities at every level, fully understand our capacity across the entire manufacturing process, and confidently deliver more competitive pricing and lead times to our customers.
Fenske: Within the orthopedic realm, can you share some examples of the types of NPI projects in which you’ve been involved? Any challenges that stand out and how they were handled?
Allsop: I like this example as it was a recent and successful NPI launch. It was on time, aligned with budget, had numerous challenges to solve, but was never under significant pressure. This was a component we supplied directly to our customer; it was part of an assembly performed by our customer. The component we supplied was made from a material we were new to working with. We found this material to be very difficult to machine, hard on tools, and required a specific way of machining to achieve the cosmetic finish our customer specified. This customer brought us in very early—in the concept phase. We had weekly or bi-weekly meetings with cross-functional groups from both organizations. We were able to run multiple rounds of iterative prototyping, uncovering any issues as they arose and addressing them in real time with our customer. Our dynamic approach allowed us to experiment with multiple tools, tool coatings, and tool paths, leading to the identification of an optimal deburring process and establishing a solid foundation for precision machining. During the prototype runs, we conducted rigorous capability studies on critical features. We adjusted tolerances and inspection levels where feasible, ensuring alignment of CMM programs between Paragon Medical and our customer. As a result, the launch quantities were delivered successfully and on time.
Borgman: In Bloomingdale, we had a similarly positive experience very recently. We began working closely with a customer on a new spinal orthopedic project. Their design was unique in its improvements over existing products on the market, and we were excited to work with them on the very first iterations of the design. This customer’s goal was to have these improvements present while still achieving or exceeding industry standards for durability and strength. It was a real challenge, but our team of experienced engineers and machinists worked closely with the customer through each phase of product development. We ran tests, altered and improved our machining strategy and manufacturing techniques, and aided in providing valuable data to our customer utilizing the scientific method to carefully monitor variables and outcomes. It wasn’t always an easy road, and there were times we weren’t sure achieving all the goals set forth was possible. However, we persisted and continued to forge a strong partnership with our customer along the way. The result was a family of products that achieved all the goals set before us. We continue to work with this customer closely, striving to deliver their exceptional product with Paragon Medical’s commitment to quality above all else while meeting our customer’s delivery needs. I came away excited to see this product hit the market and profoundly proud of our team’s commitment to the success of the project and their innovative and out-of-the-box thinking at every stage of development.
Fenske: What concerns do you encounter from orthopedic device OEMs with regard to NPI projects? Are they concerned with competitors using your services for a similar product? What about questions around IP? How do you address these concerns?
Allsop: I have not had a customer express concern about IP. This is definitely something we talk about and consider here within the NPI team as it is surprising how similar customer designs can be at times. We don’t share custom tooling with one customer to another, and we don’t share pieces of drawings between customers. We consciously make an effort to recognize if a DFM suggestion is getting too close to some unique aspect of another customer’s design.
Borgman: I agree here, and we haven’t heard any concern about IP making its way into the hands of other customers. Each NPI is its own event, and while our cross functional teams bring a wealth of manufacturing knowledge to the table, we never use custom tooling and fixturing from other projects. We seek to develop new solutions that are tailored to the customer’s specific challenges and needs. Additionally, we take our NDAs very seriously, and we never discuss similar products with our customers beyond conveying our experience and expertise with similar products.
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 orthopedic device manufacturers?
Borgman: I’ve been impressed and thankful for the power of working collectively across our fifteen Paragon Medical campuses around the globe and the advantages collaboration allows us to pass along to our customers. We have established Centers of Excellence within our organization, and I’ve been involved in multiple projects that proved we can learn and support one another on just about any product type that comes our way. If volumes exceed the current capacity of a single site, we share best practices and support the production at another approved Paragon Medical site. We can also successfully manufacture large bodies of work with a high level of part variety by working as a team and utilizing each site’s strengths. By doing this, we are able to provide our customers with the highest possible value.
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