Shepherding a new medical technology from the back of the napkin to the bench to the bedside is an exciting enterprise for innovators and their partners. While not nearly as much fun as 3D printing and prototyping, establishing accuracy in market size and understanding what manufacturing at scale really means must be considered as early as possible in the design process if a new device or technology is going to successfully enter the market and prove its value. 

The Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech and our colleagues at the Global Center for Medical Innovation (GCMI) offer the following three considerations critical for a new medical device’s potential to successfully navigate the commercialization pathway specifically related to the challenges of manufacturing at scale.

1. Designing for Manufacturability Must Be Part of the Early Design Challenge

Imagine building a house with three bathrooms but only plumbing for one. That’s essentially what happens when a medical device isn’t designed for manufacturability. It might serve its purpose perfectly as a 3D printed prototype, but producing it at scale for clinical use based on designs only appropriate for small batch production can become an expensive nightmare.

In short, the more manufacturable at market scale the device is from the outset, the easier it is for parties to make test articles, then scale at all levels. Designing for manufacturability also requires the following:

• Considering component complexity and materials: How many parts are there? Can they be easily obtained or do they require specialized materials that can only be sourced from specific places?
• Thinking about assembly: Is the device easy to put together efficiently, and who will do so at which points in the supply chain and its possession?
• Planning for quality assurance and testing: Can the device be readily inspected for quality control? Can you make the right numbers for verification and validation testing in the right specifications with the right materials within budget? You need to know this earlier than you think.
• Projecting production volume: What does your market tell you about your ultimate scale and associated production volume pathway to full commercial production? Put another way, what’s the anticipated market size? Will you need to produce 100 units a month or 100,000?

It is important to note: proof of concept is NOT a concern to scale for new medical devices, the same way your IP or scientific publications are NOT a concern to regulatory bodies.

Design decisions with manufacturing at the right scale need to be made upfront, even if large-scale production seems far off. Consider having a “manufacturability expert” looking over your shoulder during the design phase. Yes. Really. 

And if you don’t know if your true market size is 100 units per month, 1,000 per month, 10,000 per month or 100,000 per month, stop designing and step away from your auto-CAD immediately. Find out as much about your device’s true potential market size as possible. Failing to do so would be like building that three bathroom house and only plumbing for one, with potential to be much more painful and expensive.

This might seem like extra work initially, but it saves significant time and money down the road.

2. The Pitfalls of Scaling Up Your Supply Chain

Moving from small batch production to large-scale manufacturing of medical devices can throw your supply chain into disarray. You will almost always need a different supply chain at increasing production volumes in your device’s pathway to commercialization. All within an unforgiving, expensive running clock. Here’s what you need to consider:

• Sterilization: If your device requires sterilization, how will you handle it at scale? Finding a facility that can accommodate your growing production volume with sterilization assurance might be a challenge and the right facility might be thousands of miles away from much lower volume production facilities.
• Component Materials: If your device requires materials that must be sourced from and / or mined in remote parts of the globe you are asking for trouble. Materials and the components from which they are produced must have source locations and providers with redundancy. This is why availability or cost of materials and supply availability should be considered well upstream in the design and development process.
• Packaging and Labeling: Packaging and labeling mishaps are a major cause of medical device recalls. It is your responsibility to ensure the labels on your device, its packaging and handling comply with FDA regulations – no matter who is printing or producing or doing the actual placing of them on the device’s packaging.
• Milestone-based planning: Don’t assume you’ll have one supply chain for the entire journey. Plan for different production phases, such as verification and validation testing, initial clinical trials (if required) and full-scale market launch. Note that each escalating production volume requirement may well require new production partners and component suppliers who might be very far away from the predecessors’ adding  logistical challenges.
• FDA impact: In addition to the aforementioned packaging and labeling concerns, changes in your supply chain can trigger the need for new FDA submissions. Ensure your design history, manufacturing processes, and supply chain are documented and approved to avoid delays.

3. The Contract Manufacturer Conundrum

A critical decision is whether to manufacture your device in-house or partner with a contract manufacturer. Here are some factors to consider:

• Complexity of your device: A simpler device with a relatively small number of components made from readily available materials is a solid proposition for most contract manufacturing arrangements. The quality of your relationship and product from a contract manufacturer becomes an exponentially larger concern if the device is particularly complex and has not been designed for manufacturing at the market scale from the earliest possible phase.
• It’s all about right volume, right quality, right time: There is no guarantee your small batch manufacturer for proof of concept units can support your device’s verification and validation testing needs, let alone clinical trials if needed or monthly volumes in the thousands or more. Your contract manufacturer is not going to figure this out for you, and they are certainly not in business for altruistic purposes.
• Financial resources: Setting up your own manufacturing facility requires significant upfront investment. Partnering with a contract manufacturer can be more cost-effective initially, but in some cases, large investments in your own equipment and facilities to support production at market scale may make sense. How many 3D printers can you run with the material before you have to invest in molds or casts, or invest in facilities, staff and equipment at seven figure levels? These items are generally not amenable to changes to device design for scale.

The Golden Rule: Design for Manufacturability from Day One

Regardless of your market size based manufacturing approach, designing for manufacturability remains paramount. Investing in manufacturability upfront might seem expensive, but it pays off in the long run. Is that return on investment 10X, 100X or 1,000X? We can’t say with certainty, but we are confident stating it is entirely reasonable a $10,000 investment in the expertise to ensure manufacturability is baked into the design process early can easily yield $100,000 in real or discrete saving later.

Get in touch. It’s never too early. 

Organizations like GCMI can provide valuable guidance throughout the design and development process, ensuring a smooth transition to large-scale production.

By carefully considering these hurdles, you can more efficiently navigate the path from prototype to mass production for your medical device and increase the likelihood of bringing your innovation to bear on its genesis: the unmet clinical need. 

GCMI is uniquely positioned to be that partner looking over your shoulder at the auto-CAD. Beyond designing for manufacturability in terms of material selection and limiting the number of components, what else can be mitigated elsewhere upstream in D&D? GCMI is here to help you answer that. When it comes to supply chain, production partner assessment, and production at scale pathways, GaMEP is your navigator.

Together, we can increase the odds your new medical device reaches its market potential in the most capital efficient way possible.

By: Dean Hettenbach, GaMEP Medical Device Industry Project Manager, with Paul Snyder