Medical device companies continue to find ways to support their customers and frontline healthcare providers while maintaining their own businesses. Many are looking to quickly stand-up new lines or orders for personal protective equipment (PPE) and other COVID-specific needs.
Jean Olivieri, Fictiv
Injection molding machines (Image from Fictiv)
Medtech companies have networks and connections with healthcare providers and buyers, but many are likely single-sourced and don’t have the experience or expertise to quickly pivot production runs and ramp up capacity.
When ramping production or introducing a new product quickly, there are a few key stages, and each stage needs a certain skill set. They should be done in parallel, not one after the other. The current crisis has severely disrupted supply and demand and challenged work practices; all of this needs to be factored in.
Stage 1 — Get the design right
Under normal circumstances, design is a protracted process that brings in multiple stakeholders to ensure the design fits the needs of the consumer, the brand, required approvals, the manufacturing process and more. This would normally result in multiple iterations and input from various teams, not to mention focus groups and customer feedback. In this case, there simply isn’t time. You’ll need to circumvent certain processes and design quickly while still getting a good product out.
The fastest route is to start with open-source designs, of which plenty are available. Pick one that is already approved and compliant with standards. It’s easy to tweak that design, if needed, to make a product that’s fit-for-purpose and can be delivered on time and in full. This requires a streamlined but thorough process. The key right now is to design for the supply chain and the manufacturing process: Design something you can build now.
3D printing can quickly turn around parts, and while that might be the fastest route to the first part, it probably won’t be the fastest route to the 10,000th part. In the case of a face shield or other PPE, you’ll want to produce thousands every day. Take advantage of online, on-the-fly design for manufacturing (DfM) tools, particularly those that allow you to select specific materials and to review different manufacturing methods.
Stage 2 — Manufacturing and supply chain
Manufacturing processes and partners are both important and their selection is interlinked. This will need to be the first consideration in a process in which speed and reliability are the drivers. It is essential to select a process that is robust and reliable and can produce high volumes at speed. Don’t ignore quality control; it might be urgent, but it still needs to be fit-for-purpose.
There are various routes to use for this. One is to work with your current suppliers; they are on your approved vendor list and probably have the right approvals. If that avenue isn’t open because you are pivoting to a new solution, or the existing supply chain has been disrupted, then using an online platform, where pre-vetted manufacturers can be matched to demand, is a good solution. You’ll also want to make sure that the vendor has stock or a secure supply chain for the materials they need to fulfill your product. That might be resins, films or parts.
Lastly, you might want more than one supplier to avoid further disruption and ensure continuity. In fact, you might actually need multiple vendors to cope with your volumes.
Stage 3 – Fulfilling orders
There’s no point in making a great product if you can’t get it into the hands of the consumer where and when it is needed. In this case, the “where” is multiple locations, and the “when” is very soon, probably hours and days, not weeks. If this means importing the product, make sure that the logistics are locked in early and that you are ready to go as soon as orders are placed. That means you’ve decided which transport channels you plan to use, have obtained permits to export and import, and have even determined the final delivery process.
Logistics have been disrupted by COVID-19, so it’s far from business as usual. Permit approvals are backed up, transport routes are crowded and prices for air freight and ground transport are unusually high.
Keep it simple
Use open-source design, but make sure you design for volume manufacturing. Pick the a reliable manufacturing method that suits the product and volume. Design for the supply chain that is available now. Hedge your bets by picking approved vendors and multi-sourcing. And put the logistics plan in place as early as possible.
If you can get the engineers and the supply chain team working seamlessly and in parallel, you’ll be amazed at how quickly you can be shipping a new product to the front line and helping save lives and livelihoods.
Jean Olivieri is the COO of Fictiv, a San Francisco-based, rapid-manufacturing company that uses 3D printing, CNC, urethane casting and injection molding. She holds a bachelor’s degree in Industrial Engineering from the University of Arizona and a master’s degree in industrial engineering and technology management from Arizona State University.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.
