Developing a medical device product, sub-assembly, or component is enough of a challenge. Adding unnecessary time and costs to the process, however, can sink the project completely. As such, it’s critical to identify the right partners that will help move an idea through to a manufacturing success.
Fortunately, many companies will help with this process and provide expertise for a variety of capabilities. Unfortunately, not all of them are vertically aligned to take the idea through to the manufacturing stage. They may specialize on the design side or on manufacturing, but few offer the full breadth of capabilities. Working with a contract manufacturer that can start with early innovation, optimize it for manufacturing, and produce the finished product provides numerous benefits.
To help explain the advantages that can be realized from this type of arrangement, Nicholas Coburn, manager of the Advanced Surgical Innovation Center at Paragon Medical, responded to several questions on this topic. He speaks to when it is best to enlist the help of a development and manufacturing partner, how the company leverages the innovation center as part of the creative process, and how the project is optimized for manufacturing.
Fenske: What are your first steps in terms of design/development when a customer approaches you for assistance?
Nicholas Coburn: Our support teams want to understand the whole picture of your project. Comprehending the functionality of the device, sub-assemblies, and components will allow the team to provide the best support and feedback when reviewing the design with the customer. Once established, our Innovation Center team will partner with you through the design and development process, including design support, design for production manufacturability, iterative rapid prototyping, and equipment and process development.
Sean Fenske: In terms of the design and development of a new product, when is the ideal time to include supply chain partners (and why)?
Coburn: The ideal time to involve your supply chain partners is as soon as you have an idea. Whether you require components, sub-assemblies, or devices manufactured outside your facility, early involvement of your supply partners is crucial in ensuring seamless project execution. This also allows for early-stage design iterations without causing any financial impacts.
Paragon Medical has established two Innovation Centers. The Advanced Surgical Innovation Center serves markets including drug delivery, robotic assisted surgery, minimally invasive surgery, and additional soft tissue markets. The second Innovation Center is dedicated to the orthopedic market. Both offer services that include design engineering, iterative rapid prototyping, equipment and process development, and, most importantly, design for production manufacturability. Paragon Medical’s Innovation Centers will support your development projects and transfer you to one of our many production sites for qualification and commercialization.
Fenske: Can you expand on the purpose and capabilities of the Advanced Surgical Innovation Center?
Coburn: Our Advanced Surgical Innovation Center (ASIC) is purpose-built to support Paragon Medical’s production sites with prototyping and design support as it can work with our customers in the early design and development stages. ASIC offers design support, design for production manufacturability, iterative rapid prototyping, and equipment and process development—all the capabilities a customer is looking for at this early stage for their projects. We understand that speed is of the utmost importance, which is why ASIC was built to turn prototypes around in as little as one week. By incorporating prototyping and early development into Paragon Medical’s service offering, our team can become familiar with the design alongside our customers. If this early-stage work is outsourced, the manufacturing team begins at a disadvantage and has to ramp up much faster.
Fenske: Is ASIC intended for established medical device customers, smaller start-ups, or both? Can it cater to all needs?
Coburn: Paragon Medical’s two Innovation Centers are meant to serve all customers looking for design engineering support, iterative rapid prototyping, and equipment and process development. All customers are welcome to visit the Innovation Centers and work through design concept testing. We've had the pleasure of partnering with startups right from the early concept stage, as well as assisting large OEMs seeking extra design support or a fresh outlook, and everything in between. Our team has diverse experience, and we're here to cater to the full spectrum of customer needs.
Fenske: You mentioned that ASIC is a collaborative space. Can you elaborate on how customers can leverage the Innovation Center from a collaborative development perspective?
Coburn: Paragon Medical’s Advanced Surgical Innovation Center offers on-site customer visitation and collaboration. This allows our customers to do on-site fit-form-functional testing and design feature adjustments on the fly. This saves significant time and money on both sides. It also gives the customer the ability to walk away with a design they feel confident in because they have seen it work with their own eyes.
Fenske: What are the common challenges encountered in moving a design to manufacturing?
Coburn: One of the predominant challenges often encountered involves transitioning from a prototyping-centric environment to a full-fledged production manufacturing facility when the two facilities do not interface. A prototyping-only house is not concerned with production manufacturability, so they will make your parts as you have designed without keeping long-term costs in mind.
When you come to Paragon Medical, we will work closely with you on your designs to ensure they are production-ready. Our team of highly skilled tool designers and engineers have extensive knowledge of the Paragon Medical production processes. Even better, our Project Management Team will make for an easy transition from our Innovation Centers to the production site.
Fenske: You mentioned design for production manufacturability. Do you aid in other “design for” elements with customers, such as testing, inspection, or others? How do these affect time to market and cost?
Coburn: ASIC works closely with our design and production site teams to provide our customers with a production-ready product design. We will be transparent with our customers on whether we have the production capability to manufacture a specific design, while also offering equipment and process development support as needed. The main goal of our team of highly skilled tool design engineers is to set up the customer with the best success as their design moves to commercialization. This includes production DFM, dimensional and tolerancing review, and up-front inspection processes. This will streamline the time to market to minimize any changes during qualification or production, which saves costs for the customer.
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?
Coburn: We only touched on how ASIC can support equipment and process development. To further expand, ASIC is designed to engage in the early stages of our customers’ part development process. This leaves all doors open in terms of how to manufacture their designs. ASIC can develop a customer-specific manufacturing process so it is ready to transfer to production in a short timeframe. Paragon Medical’s Innovation Centers are always growing their capabilities and capacities at all levels.
Internally, ASIC continues to grow and represent all of Paragon Medical’s Advanced Surgical Division production capabilities on a prototyping level. In April 2024, ASIC added a state-of-the-art Citizen Swiss with an integrated fiber laser cutting system to mimic the production capabilities at our Southington, CT, site. Future prototype capabilities include cold coiling, needle grinding, and laser welding. These are all production processes currently offered at our Advanced Surgical production sites (located in Connecticut, Massachusetts, and Siechnice, Poland).
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