If you’ve worked with an independent design firm to create the concept for your medical device, you might assume that bringing it to life will be relatively straightforward. Hand the complete design documentation package to a manufacturer and voila — production can begin quickly. Right?

You might be right — if you’ve worked with designers and engineers who truly understand what it takes to create a manufacturable concept. 

But more often than not, clients who engage MPE Inc. with a design in hand are surprised to discover that there’s still quite a bit of work to do to prepare it for the rigors of production and assembly. This usually requires an unfortunate but necessary “reset” — a pause in the process to revisit and reimagine the concept through the lens of manufacturing. 

Resets are expensive and can significantly delay your time to market. But they can be avoided if you approach the medical device development process in a holistic way from the get-go. 

Our readiness guide — based on the principles we use when leveraging our unified capital equipment commercialization platform — will help you avoid costly rework and put your product on the path to faster market success.

Take five essential actions to make sure your design is up to par.

1. Count the cost of every design choice.  

Design firms excel at wowing product developers (especially new-to-the-MedTech-industry start-ups) with eye-catching medical device designs that promise to outperform the competition. And of course, there’s nothing inherently wrong with investing in a good design. After all, good design is a vital part of helping clients corner a larger market share.

But there are two critical questions to ask before you accept a design from one of these firms:

Your design should never be developed in a vacuum, especially if you want to achieve a certain target price point, minimize your total cost of ownership, and maximize ROI. It’s essential to consider what it will take — and what it will cost — to make that concept a reality both now and down the road. 

Unfortunately, independent designers don’t always understand just how much their design choices will cost you. That’s why we advise paying particular attention to the following areas.

Materials

The materials you use to create your medical device have direct implications on your product’s cost. Say your design calls for a painted finish. The cost to source and apply that paint can cause your budget to explode. Now imagine the design also calls for a custom paint color rather than using one of the hundreds of readily available industry-standard hues. This design choice will ratchet up the cost even further.

Along the same lines, sleek, metallic, and high-gloss looks are typically more expensive than unfinished or matte alternatives. Opting for adding a metallic flake, or polishing metal to achieve a high sheen are finishing options that add up fast.

Mixing and matching materials to create a textured or multi-faceted appearance is also costly because it requires multi-step processing. 

These are just a few examples, but there are many more material choices that can impact your project’s budget. Only you can decide if any given design choice is worth the cost. But it’s vital to understand what each one will mean for your bottom line before you approve it.

Tooling

Designs that feature contours, organic shapes, hidden fasteners, and ergonomic elements look gorgeous on paper, and it’s hard not to be dazzled by them. But features like these are most commonly created using injection molds and extrusions which require hard tooling. 

Each hard tool can cost between $50,000 and $130,000 to make or source. They can also take months to build. And that means if you have a dozen design elements that all require custom tooling, you can easily spend more than $1 million (not to mention significant amounts of extra time) just to develop the tools that make your design choices possible. 

The up-front cost of custom tooling might be worth it if your manufacturing volumes are high. The larger the quantity you produce, the lower the cost-per-unit and total cost of ownership. But many of our clients only produce 50-100 units to start with. At low-scale quantities like these, it often becomes necessary to adapt the design and choose lower-cost alternatives (like shapes that can be produced using existing tools or alternate processes).

When assessing your tooling needs, remember: Just because something can be done doesn’t mean it must be done. Take your users’ needs and your own budget and timeline into consideration when deciding whether features that require tooling are worth the investment.

Components

It’s also important to consider how you’ll source the various components that make up your medical device. Designing custom parts for your product may be the best choice if you want to differentiate your device from the competition and provide an exceptional user experience. 


But again, take an honest look at the cost before you go this route. Custom parts require extensive testing and validation before they ever reach the manufacturing phase. And as explained above, producing them may require that you first invest in expensive tooling and machinery. It’s often wise to leverage commodities that conform to industry standards when selecting components for your device. 

2. Weigh the supply chain implications of your product requirements.   

The materials, components, and tooling that a manufacturer will use to produce your device must come from somewhere. Therefore, when assessing your design’s manufacturability and viability, it’s also critical to consider where you’ll get the following elements:

  • Raw materials (e.g. sheet metal, plastics) your product is made of
  • Off-the-shelf components (from bolts and fasteners to robotic arms) that make up its form and functionality
  • Packaging materials and shipping systems you’ll rely on to get your product to your end users

Your product’s supply chain ecosystem can make or break your ability to bring your MedTech device to market on time and within budget. So before you finalize your design, make it a priority to: 

  • Confirm the supplies you’re counting on are available
  • Find out how long it will take for parts and materials to arrive — especially if you’re sourcing from overseas and must comply with trade agreements and tariffs
  • Understand whether or not your suppliers require a minimum quantity to fill your order
  • Line up alternatives so you can pivot quickly if all or part of your supply chain falls through

Consider this as well: Bringing a device to market isn’t just about manufacturing it right now. You’ll also need to continue to produce it in the future. And that means it’s imperative to consider whether its parts and materials will be available down the line.

See how one OEM optimized its supply chain and manufacturing operations to realize significant cost savings.

3. Ensure design and engineering drawings are realistic and consistent. 

All too often, the drawings new clients bring from an independent designer are still in what we call the “mad scientist” phase. They look impressive at first glance but lack key pieces of information and have not been tested or validated to confirm if they’re viable.

Some manufacturers will take your mad scientist design and create it — no questions asked. But if it hasn’t been thoroughly tested and validated, you may end up with a less-than-desirable result (i.e. wobbly parts that should be sturdy; final products that don’t meet safety standards).

Manufacturing-ready medical device designs are mature, detailed, and consistent. Look for:

  • Detailed information about materials and finishes
  • Clearly labeled parts and processes
  • Tolerance analysis to make sure pieces and components can go together properly
  • Options for repetitive and automated assembly
  • Instructions for small-scale assembly
  • Photos showing how parts fit together
  • Safety protocols and precautions to follow

It’s also critical to look for evidence that the design has been tested and vetted. If it’s never been put together or prototyped, a reset will likely be necessary. (More on prototyping in section 4).

Bringing offshore designs onshore.

If you’ve previously engaged an offshore or contract manufacturer but are regionalizing your operations to future-proof your business, you may need to convert your existing design to ensure it functions within a wholly different system. 

This involves:

  • Selecting and sourcing materials that are readily available in the U.S. (these may be different than those available in other parts of the world)
  • Converting units of measure to ensure designs line up with common U.S. sizing standards 
  • Finding opportunities to automate processes and speed up assembly — for example, by utilizing tools such as progressive stamping, robotic welding, and quick-turn cells  

Why is this necessary? Designs generated in Asia and other offshore manufacturing hubs are inordinately labor-intensive. In these locations, hiring a workforce is much less expensive than it is here in the U.S. There, what companies lack in equipment, automation, and robotics, they make up for in plentiful, inexpensive labor. 

Since labor is much more expensive here, it’s essential to adapt your design and find opportunities to manufacture it efficiently.

4. Test multiple prototypes for viability and scalability.  

It’s possible to design a medical device that’s manufacturable but not scalable. After all, you can make nearly anything if you’re willing to pay the price and carefully craft it by hand. 

But when it’s time to produce and assemble your product on a larger scale, it’s all about speed, agility, repetition, and cost-preserving efficiency. Going through an iterative build process — which involves using low-to-high fidelity prototypes and taking them through a low-volume trial — gives you the input and feedback you need to adjust your design and optimize it for higher-volume production. 

At MPE Inc., this process looks like this:

  • Invite engineers and assembly workers to take a first look at the design, drawings, and instructions and provide input on how to tackle the construction process. 
  • Identify the needed supplies and assembly fixtures.
  • Do a low-volume build of five to ten complete products to simulate the assembly process and confirm that work instructions are thorough. 
  • Think through station assembly times (called tack times) and verify they’re realistic and achievable. 
  • Eventually move to a higher volume build. 

Throughout this whole process, we’re assessing, learning, tweaking, and fixing problems before they become bigger issues on a grand scale. 

The iterative build process in action.

One of our clients initially manufactured a patient transfer system by manually assembling the product one at a time. They came to us for help adapting their process to increase the volume of production and cut down on manufacturing and assembly time.

To get their design ready to scale, we:

  • Evaluated the space we needed to manage the assembly process, organized parts and supplies in order of use, and looked for ways to create easily repeatable processes 
  • Prototyped sub-assembly systems to speed up and automate portions of the process 
  • Identified opportunities to source materials like stripped and crimped wires through the supply chain rather than have people manually strip and crimp wires
  • Had designers and engineers watch the assembly line to look for opportunities to optimize the design and eliminate pitfalls 

Our approach will enable this client to significantly speed up production time, reduce their time to market, and start seeing a higher return on investment.  

The importance of testing multiple prototypes. 

By working with multiple prototypes at various stages, you might discover that your design is viable but exceptionally hard to assemble and disassemble. Since medical devices require end users to perform some level of assembly and/or disassembly as well, this could make initial manufacturing difficult — and also negatively impact market adoption. 

Based on what you learn, take an iterative approach to making changes and continue to prototype, test, and refine until you land on a workable concept that can stand up to the rigors of manufacturing.

5. Streamline your next product’s development with MPE Inc.’s unified commercialization platform.

Bringing a medical device to market is long, arduous work. And the last thing you want is to invest in a beautiful, impressive design only to find out it’s too expensive (or impossible) to produce. The farther down the road you’ve gone before you discover problems with your design, the more time and money they’ll cost to fix.

That’s why it’s ideal to choose a partner that offers design, engineering, compliance support, and manufacturing under one roof. A vertically integrated approach ensures that issues are uncovered and mitigated early — and makes your path to commercialization as quick and cost-effective as possible.  

Our unified capital equipment commercialization platform redefines the MedTech development and manufacturing industry and offers you the benefits of working with an onshore, integrated organization that infuses compliance, differentiation, and adoption readiness into every stage of your product life cycle. 

So if you really want to make sure your medical device design is ready for manufacturing and production, start — and end — with MPE Inc. Our team can deliver an exceptional concept that’s designed through the lens of usability and manufacturability from day one. Let’s talk.