How to Build the Supply Chain that gets Speed and Scale in MedTech

Written by Eric Sugalski

Here's what usually happens in MedTech. A development team is thick in the details -- designing, prototyping, testing..

They reach a level of technical maturity when they believe they're at "Design Freeze" -- a topic discussed in more depth HERE.

Then, "It's time to build this thing. Let's engage some CMOs."

A basic RFP package is assembled and off they go. Some responses from sales folks begin to trickle in. NDAs are executed, early conversations are had, and then...

Nothing.. Crickets..

They reach out to the CMO sales reps to get an update and get the token response: "Technical resources are tied-up. Going to take some more time to get quotes in order. About 2 weeks.."

There seems to be high interest from the sales folks, and they recognize that these are big, slow-moving companies. So, they wait.

Those 2 weeks go by. Then another 2 weeks. Then 2 months. Still nothing. And the same old reply from the sales rep, "Still interested and moving along, just taking more time than I thought.."

So it goes.

If you've been through this waiting game, you know the frustration that I speak of. You've burned down your runway due to the sloth-like CMOs.

Well, here's the deal...

Building a supply chain for a new product is a LOT of work. Finding the right suppliers, vetting them, seeing if they're interested, collecting quotes, and pulling all the pricing together.. It takes months. And typically, this up-front supply chain development process isn't a revenue source for CMOs.

Hence, a lot of talk, and very little action..

So, what should you do about this process? Well, if you want scale, you'll probably need to engage the slow-moving CMO. But, if you want speed, you should plan to take care of the legwork on the front end YOURSELF.

But how do you go about this process?

Rapidly Building your Supply Chain in 5 Steps

If you're willing to get in the driver's seat, things will go much more quickly. Here are 5 steps to put supply chain development into high gear.

Step 1 - Engage Specialty Component Suppliers

Ok, this has to come early -- really early. If you're building a device with bioresorbable resins, stent-like scaffolds, microfabrication methods, customized sensors, or anything else that requires highly specialized components and/or processes, you've got to get this going in the Concept phase.

PRO TIP -- Don't try to change an existing manufacturing process to replicate what you have in the lab. Big mistake, always. Instead, change your design to fit the existing process.

Understand the constraints -- they're there for a reason. Engaging with specialty component suppliers typically has some NRE cost, so be prepared to pay them not only for building but also for the development process. They'll need to spend a fair amount of time with you, educating you on their materials / processes, and working with you to update the design to fit their established best practices.

Again, do this early.

Step 2 - Determine the Proto to Production Path

When you're in development, you're probably going to be iterating with 3D printed parts and other rapid, low cost methods. That's fine and makes perfect sense when you are working through the technical and usability details.

But, there will come a point when you need to get closer to the production intent materials and processes, like injection molding and/or sheet metal stamping. The big players will be talking fully validated, multi-cavity tooling. You're not there yet though -- not even close. You need to be investing in single-cavity cassette molds. These will primarily be learning tools -- ones that you can run to understand performance during Engineering Verification Testing. (More on that topic HERE.)

Tweaks and changes during the single-cavity tooling process are the norm. And those tweaks take time. So, plan accordingly.

This is the process you need to segue from prototype to production. Identify the long-term manufacturing methods. Then, utilize rapid tooling vendors to trial the production materials and processes in low-volume.

Step 3 - DIY Assembly

Plan to have your engineering team build-up those early units. Sure, the labor costs of your engineers will be much higher than assembly techs, but this process isn't about cost efficiencies. That comes later. You're giving your engineering team first-hand knowledge of the issues that will arise in building.

The tricky steps that require 3 hands, the mess that (always) comes from using adhesives, the painful process of routing cable harnesses without retention features and proper service loops. If your engineering team feels this pain, they'll do something about it. They'll design assembly jigs, they'll replace glues with snaps, they'll update part designs to accommodate assembly operations. Make them feel the assembly pain.

Think of the assembly process as part of the product. The engineers can and should think this through in the same way that they are designing component features in CAD. And just as your team will be creating part drawings, they should be developing the preliminary work instructions that map out how the assembly steps can and should be executed reliably.

Step 4 - Engage CMOs

Ok, NOW that you've gotten through these DIY details, it's time to engage potential CMOs. You've done a lot of the supply chain and manufacturing legwork. This not only benefits them, but it also benefits you.

How DIY Supply Chain benefits CMOs:

• They'll see you as needing less hand holding through DFM/DFA

• They'll view your product as more technically mature and more likely to achieve high yield.

• They'll view you as a faster revenue generating opportunity and bump you up on the priority list.

How DIY Supply Chain benefits you:

• Gives you visibility into the cost drivers of your product, which helps with cost optimization later.

• Since you hold the data and process know-how, it reduces your CMO switching costs if things don't go to plan.

• You'll get more CMOs interested and up-to-speed quickly. This means you'll be closer to producing product and generating revenue

Step 5 - Design Transfer

Sure, design transfer has been taking place through this process -- as you've been reaching out to specialty suppliers, component manufacturers, and the like. But there's still good reason to dedicate time and process to a formal design transfer meeting.

This is usually much more than a meeting though -- it's usually a week or two onsite at the CMO. Some of it will be in the conference room, but hopefully most of it will be out on the shop floor. You should be bring along all your samples, jigs, test equipment, etc. and put together a mini-assembly line to ensure that the process in your team's head is sufficiently transferred to the folks on the operating floor.

Will the process change? Absolutely.

But, dedicating that time onsite will prevent the guesswork that always happens with an "over-the-internet" design transfer approach. Plus, it'll give you an opportunity to build relationships directly with the manufacturing leads/managers, which always comes in handy for resolving issues when they arise.

To Sum it Up..

If you follow these simple steps above, you'll be much more likely to accelerate the process into manufacturing while achieving the scale that you'll ultimately need to be successful in MedTech.

To recap on the key points:

• Identify and engage the specialty suppliers early (in Concept Stage)

• Determine how your prototype materials and processes will translate into low-volume production equivalents

• Get your hands dirty with DIY assembly

• Engage CMOs at the right time (after you've worked out the kinks)

• Formalize design transfer and plan to spend some time onsite

Hope this article was useful to you.

Here are 3 ways that we can help you move forward in MedTech:

1. Gap Assessment - Need a third party review to assess technical, regulatory, quality, and manufacturing gaps? We'll work with you to assess your work to date and help you put the plan in-place to fill the gaps and streamline execution. ~$15k

2. FDA Pre-Sub - Need clarity on pathway, labeling, predicate/reference devices, test plans, and other key regulatory topics? We'll help you put the regulatory strategy in-place, build out the documentation to support your intended position, facilitate the meeting with FDA, and ensure there are clear next steps to guide development. ~$35k

3. Prototyping - Need device prototypes for bench testing, animal studies, early clinicals, or other purposes? We'll help you with design, prototyping, and testing to move your MedTech venture forward with speed and focus. ($, Use our Pricing Calculator)

Interested in exploring collaborations with us? It's easy - Just drop us a note HERE.

Thanks!

Eric Sugalski

Founder & CEO, Archimedic