The idea for a new product comes to mind. You jot down some notes or perhaps even sketch it out on whatever’s nearby, even a napkin. But then, what’s next? How does an idea or a rough drawing become an actual product that’s ready to be launched into the healthcare market? A significant amount of work is ahead to make the idea a reality, so it’s critical to have the right partner helping.
The right design and manufacturing partner will know the steps required to take a raw concept and shape it into a product that’s ready for launch. As such, there are a number of things to keep in mind, such as what’s involved with early development, whether the design partner should take the product through production, tests required, packaging and sterilization considerations, and numerous other factors.
With all of this in mind, David Philbrick, new business development manager, and Lorenzo Vaccarella, MBA, director of new product development, at Paragon Medical shared their expertise on these considerations in the following Q&A. They respond to questions around all of these concerns to ensure medical device OEMs truly understand the project that may be ahead of them.
Sean Fenske: In terms of getting the idea across to you to begin the development process, what is required? Can it truly start with a “napkin sketch”?
Dave Philbrick: We have done plenty of design projects that start with a napkin sketch—just this week even. We have customers who may not be aware of the most recent updates to our capabilities as our equipment and technology continues to change and evolve. A customer could be thinking of traditional machining and manufacturing methods, but we might be able to employ subtle tweaks that would introduce an automated solution for better overall efficiency. And, with offering both additive and subtracting manufacturing services, we can evaluate which method makes the most sense for the goals our customer is trying to accomplish. Sometimes, it just takes a little bit of information via napkin sketch, which helps to draw out questions and connect the dots of the technologies that could be used. There are unique technologies available today that can enable a robust, validated, production flow while generating a competitive part cost.
Lorenzo Vaccarella: From my perspective, ideally, any type of visual aid is always helpful in getting a customer's idea across, including the infamous napkin sketches. Customers will provide anything from PowerPoint to a 3D CAD model and/or 2D drawings, if available, to a video or even a crude prototype. Even with today’s technology, I will still get a clay prototype now and then.
Philbrick: That is a great point, Lorenzo. The napkin sketch is getting more dated these days, but a presentation where customers can share illustrations of their assembly models or files so we can visualize the interface is helpful.From there, we ask the customer to send us their solid assemblies and component files so we can look at them, do a more technical critique of the tolerance window, and measure the components to make a better evaluation of the design.
Vaccarella: Sometimes our customers come to us even before they have an idea that they would like for us to embark on and conceptualize for them. It may be a problem they are trying to solve, and they will ask us to provide them with a solution.
Philbrick: We have had scenarios where we have been sent a lot of information in a general sense, and we are asked to create a solution. We are fortunate that we have the teams available to solve specific problems on component designs or the ability to design an entire product platform. We have seen many diverse requests over time.
Fenske: What is the very first step in the process once a customer brings an idea for you?
Vaccarella: The initial step is to ensure we set a non-disclosure agreement (NDA) in place to protect both parties. After we have a mutual NDA in place, we will kick off an initial conversation to understand the opportunity being brought to us to either design, solve, or develop. During this initial conversation, we will also present to the customer a Project Responsibilities Matrix (PRM), which highlights our phased-gate approach (Phase I-IV) and contains a list of deliverables that allows for both Paragon Medical and the customer to select which phase deliverables each party shall be responsible for. Once the PRM has been completed, a comprehensive, fully detailed proposal [containing the scope of work, cost per phase(s), and duration of each phase(s)] will be drafted and provided to the customer for their review and assessment.
Philbrick: For sub-assemblies, or projects where we are not creating the entire device, it is our job to get enough information from our customers so we can ensure the right teams are in place to support the project and set the customer up for success.
Fenske: Are design/development projects typically coming from start-ups or do established firms seek assistance in this early stage as well?
Philbrick: I see many instances of both. Everyone can be stuck with a thought that does not allow you to move forward with an idea, whether you are just starting out or an established organization. We all need an outside perspective now and then. Across the board from start-up to established firms, we’ll see teams that are looking to speed up their project’s time to market, but don’t have the internal people resources to support it. Paragon Medical can come alongside and supplement with our engineering, regulatory, and quality expertise to serve as an extension of the OEM’s team to help drive commercialization.
Vaccarella: Within new product development, 95% of our opportunities stem from medtech start-ups, universities, or incubators (e.g., a “think tank” within a hospital). In the early phases of a project, these types of customers often have a limited budget; therefore, we will assist them with Phase I deliverables with the goal of delivering their proof of concept. Then, they will take the proof of concept to perform testing of some type and/or obtain Voice of Customer, as well as showcase the proof of concept to investors to seek further funding to help move their project forward. After a customer has secured additional funding, we can continue with the subsequent phases (e.g., product development, design verification and validation testing, and manufacturing scale-up).
Philbrick: On the other hand, we have well-funded companies that are ready for designing the device concept all the way through to commercialization. They are requesting proposals that include device design and product development, and also want us to manage full-scale production of their product line. We do get requests at both extremes. Further, as Paragon Medical continues to expand our capabilities and global reach, we can serve both customer types with solutions.
Vaccarella: So really, no matter where a customer is in their design and development journey, we can support them at any point within our disciplined and robust phased-gate process.
Philbrick: One thing I really appreciate about our NPD team is they have such a well-defined methodology of how we do our design work. We can easily provide our customers with a menu of options on Phase I through Phase IV activities on our Project Responsibilities Matrix to understand exactly what they need throughout the design, development, validation, and launch process. Our customers then select what they need from us and determine what they want to do themselves. The scope of the project is then easily created. It is powerful for our customers to clearly see our menu of end-to-end solutions and articulate what they need.
Fenske: Where does design for manufacturability come into play?
Vaccarella: Design for manufacturability (known as DFM) must be considered early in the design process. DFM begs the question, “How will the part or assembly be manufactured?” We involve our new product introduction (NPI) team (which is our manufacturing team) with our product development team early in Phase II (product development phase). The sooner the manufacturing team is involved and understands the product, the better equipped they will be to decide how to manufacture it effectively. Equally as important, when DFM is included early in the design process, it saves time and costs down the road.
Philbrick: Our teams can develop a custom manufacturing process if needed by the product’s unique design. We will work through creating new manufacturing techniques to get the device where it needs to be and ensure the process is robust. Paragon Medical has two Innovation Centers—one dedicated to orthopedics, machining, and additive manufacturing and the other dedicated to soft tissue devices for applications such as drug delivery, MIS, and robotics. The Innovation Centers are structured to support this early-stage process and equipment development work, along with providing rapid prototypes. That means when it is time to transfer a product into production, we already know the process will be stable and have proved it to our customers by testing it.
Fenske: What about material selection? What are the important considerations with that?
Vaccarella: When it comes to material selection, the most important consideration is to understand various requirements such as application, performance, cost, manufacturability, and biocompatibility. We ask our customers early on if they have a product specification document to understand such requirements, and if a customer does not have a product specification document, we will collaborate with them to define the requirements accordingly. Once the requirements are known, we then perform our research to select the required material(s). Knowing how and what the product is going to be subjected to in the field also plays a factor in selecting a material(s). Other tests and processes, such as transit, accelerated aging, and sterilization also need to be considered when selecting a material(s) for the product. We also want to ensure the product will survive when stored in various environments and subjected to various conditions.
Philbrick: When a customer works with Paragon Medical, they not only receive our design experience, but they also get access to our healthcare knowledge based on the types of products we have designed and developed in the past. We know how these products need to perform in the field and we will ensure the processes are designed or created to sustain reliability.
Fenske: Do you offer additional services that may not always be associated with device development, such as testing, packaging, or sterilization recommendations? Do these enter into the development phase, and if so, how?
Vaccarella: Paragon Medical offers packaging design and test services, as well as offering both design verification and validation services. The types of design verification tests we provide and support are mechanical, electrical, biocompatibility, transit, accelerated aging, and real time aging. We manage sterilization validation activities, from gamma irradiation to EtO to vaporized hydrogen peroxide, etc. We can also conduct design validation testing on behalf of our customers where we will collaborate on the design validation protocol with our customers to ensure alignment.
Philbrick: Paragon Medical has lots of experience with sterilization validations. We have designed products for customers and then offered to perform the sterilization validation, which leads to discussing how products should be packaged. The ability of Paragon Medical to manage the sterilization aspect of the device and packaging in a production process works out great for our customers. We will also maintain the design history files (DHF) for sterilization validations coordinated by Paragon Medical engineering teams. We are willing to operate from early-stage design work, support testing, transfer it to manufacturing, and to specialized packaging whether it is sterile or not. Our team is there to support a customer’s full product lifecycle no matter what stage they are in.
Fenske: When companies want to embark on a development project with a partner, what are some of the aspects they have not considered or should keep in mind?
Philbrick: First, you want to get an understanding of the company you are considering a partnership with. When people come to us, they like to know what our history is. They want to understand our pedigree, our capabilities, and how we came to be who we are today. Many companies claim they are an end-to-end provider, so it is important to understand what those services look like for your project. We can always help you with theoretical design, DFM, verification, and validation testing. We can aid the commercialization launch of your device, sustain the manufacturing with engineering support, provide project management, and offer ongoing demand planning.
Vaccarella: Those types of conversations are a terrific opportunity to uncover what type of end-to-end solutions your partner can provide. Sometimes people think of us as just a manufacturing company, but we offer so many additional services through our in-house design, engineering, quality, and manufacturing teams.
Philbrick: It is also important to understand what sort of design and development resources your potential partner offers. Paragon Medical’s innovation centers are designed to provide access to development and manufacturing services. Both facilities allow customers to take advantage of a full suite of offerings that allow for iterative prototyping and design. There's ample opportunity to draw from the collective expertise shared across our network of facilities.
Vaccarella: Finally, thinking through where a customer is intending to launch the product globally and what their manufacturing needs might be is important when taking on a new opportunity. Can the partner you are evaluating manage your full scale-up and launch? Are they positioned in the right markets you are looking to launch in? With our global footprint, whether you are planning for a regional launch or targeting a specific demographic market, we have the facilities to serve you with speed and agility while simultaneously providing a variety of services that minimize both cost and logistic challenges.
Fenske: Do you have any additional comments you would like to share based on any of the topics we discussed or something you would like to tell medical device manufacturers?
Philbrick: Early supplier involvement is key to a successful product launch. Bringing in a manufacturing partner to assess the design allows for time and cost savings down the road.
Our product development teams will enable you to design the next breakthrough innovation. If you have an idea for a new device, a problem that is proving difficult to solve, or are looking to outsource design and development work, reach out to either of us:
Dave Philbrick: dave.philbrick@paragonmedical.com
Lorenzo Vaccarella: lorenzo.vaccarella@paragonmedical.com
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