Medtech Manufacturing for Innovators & Start Ups: What You Most Need to Know

Insights from a deep dive into medical device innovation and production with GCMI’s Saylan Lukas and GaMEP’s Dean Hettenbach

 

Given the patient safety requirements codified in the United States Code of Federal Regulations overseen and enforced by the Food and Drug Administration, medical device innovation is a challenging enterprise to say the least.

 

It is also a landscape filled with pitfalls that need a holistic, long range view to avoid them. Considering what manufacturing at scale means for a new device or technology is one such pitfall that needs consideration earlier in the design and development process than one might know or believe.

 

Design decisions with manufacturing at the right scale need to be made upfront, even if large-scale production seems far off. A device 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.

 

Last month, GCMI Interim Executive Director Saylan Luke and Georgia Manufacturing Extension Partnership’s Dean Hettenbauch unpacked the common challenges that many face when entering the medical device space and the steps to take to avoid common pitfalls [particularly as it relates to manufacturing].

 

While we invite you to check out the hour long recording full of high value information and insights, but as long as you’re here, check out some of the top takeaways.

 

Engage regulators early, but be well prepared.

Start the process of engaging the FDA (assuming you intend to market your device in the United States) as soon as possible. They are there to help and more well equipped and committed than ever to do so. BUT, put in the time prior to any engagement with regulators to be as well informed as possible. Know that they don’t answer vague questions. Seriously consider, vet and engage a regulatory consultant with experience specific to your technology and its prospective pathway or pathways.

 

Be strategic about claims.

Do not obsess over claims so powerful they impede traction and cash flow. Take an incremental approach gathering data from “gen 1” devices, early adopters (and some cash flow) that then supports expansion of claims you want to make along with the required submissions.

 

For example, instead of claiming a new sensor can provide a diagnosis based on AI, back up. It is faster and easier to get to market by claiming the new product only generates and collects data, which the user must interpret themselves. More data can be collected from initial users which can be used to prove the sensor performance paired with a powerful AI/ML algorithm supports a stronger diagnosis claim.

 

Another example is a device’s shelf life. Shelf life is a claim on the device’s label. Hospitals often want a 2-3 year shelf life claim, but that takes substantially more time in product development. Go shorter on the initial shelf life claim to start. Instead, go to market with a 6 month shelf-life. Then complete a longer 2 or 3 year shelf life study once the product is on the market and you are generating sales. 

 

Plan for 2X the time, 2X the dollars and many multiples of iterations.

Unrealistic design, development and testing schedules are common, potentially costly and largely avoidable. Innovators are frequently overoptimistic and overconfident that something will work the first time. Every new product has some unforeseen delay be it a test failure, a delay in raw materials, etc. Double your time estimates and double the cost of cost to milestone achievement.

 

Do not underestimate the number of iterations required for milestone achievement. You will always achieve a better design with multiple iterations and the associated gains in volume and value of the associated feedback. And that’s just to get to design freeze. But jumping to design freeze and investing in tooling before achieving sufficient feedback or proper failure mode analysis is the antithesis of ‘de-risking’ your device or technology.

 

Speaking of cost, innovators often set COGS targets low in order to make appealing to investors. They fail to include costs related to final assembly, packaging, labeling and inspection. Realistic hourly costs and overhead will add to COGS in pitch decks, as it should and as prospective investors need to know.

 

Innovators commonly want to jump to the flashy version of the device as quickly as possible to entice investors. But proof of concept prototypes, sometimes “quick and dirty” iterations are needed. Define each prototypes’ purpose; mode of action proof for example.

 

Note: Prototypes cannot be used for official verification testing. Test articles must be equivalent to final manufacturing methods. Early prototypes for proof of action, function testing, and useability do not need to endure especially high levels of rigor. But when the device is ready, most products require 30 parts for each test, and that is for low to medium risk devices. 

 

What’s the backup plan?

What’s your backup plan if the device fails testing at any particular juncture? Include the potential for testing failures in your timeline and ensure management and investors are aware of the risk.

 

Production at scale

There is a big difference between making 1-5 prototypes and making hundreds or thousands of production units. There will almost certainly be design tweaks required at the juncture of manufacturing at scale as well.

 

Much like the benefits to engaging with regulators early in a new device’s design and development life cycle, creating a manufacturing plan in “Phase One” is wise. Initiating discussions with manufacturers as your design coalesces about different ways to mass produce componentry will influence decisions and design requirements for 3D printing vs/ injection molding or extrusion.

 

As Covid-19 laid bare, single source for suppliers, contract manufacturers, assemblers or the manufacturer of record is risky. Innovators need a holistic supply chain plan with multiple backups for each source type inclusive of raw materials and some of those suppliers may need to be ISO 13485 or 21CFR820 compliant or certified. 

 

What’s missing or commonly overlooked in materials?

Packaging and labeling is all too frequently absent from medical device innovators’ plans. It might seem trivial, but failure to plan for those critical elements can lead to significant delays downstream with equally significant associated costs. The number one cause of a recall involves labeling. Mistakes on labels mean recalls!

 

Packaging and labeling doesn’t have to be as pretty or expensive as an Apple product, but those elements are not insignificant in cost and time to produce, acquire and then ‘fill.’

 

The Last Mile

Transit simulation, drop shipping, and the “shake rattle and roll” testing. Is it sterile and testing reveals insufficient protection in packaging? Did the device break through the side of its packaging? Does it need to be kept in a defined temperature range including during transit? If the company has staff on salary, avoidable delays in packaging, labeling and shipping can be crippling. 

 

Insufficient detail in specifications and unnecessarily tight tolerances

Innovators must ensure specifications on raw materials are sufficiently specific. And that does not mean intense specificity in tolerances. Setting tolerances far too tight is often avoidable and unnecessary. Just because a component manufacturer says they can hold a 1/1000 inch tolerance, does not mean you should set them that tightly. Think: in the future, once you’ve launched and you are 1,000 components in, what happens if they’re out of tolerance by 1/1000ths of an inch? Are you going to scrap them, then wait for a return batch, or are you going to open the spec and try to justify your way out of it? The FDA doesn’t like that. Challenge your team for the widest acceptable tolerances.

 

What else?

 

Biocompatibility. Just because another product uses the same material you plan to use, especially if it’s plastic, it is very difficult to justify to the FDA that your new device is biocompatible without new test data. This is because additives are commonly used in injection molding or extrusion and the FDA is concerned about toxic chemicals leaching out of the plastic. Design verification and validation test articles must be equivalent to final manufacturing units to prove your process plus material is biocompatible.

 

If you take just two things away from this piece, make them these.

It’s really hard to go backward to rework regulatory pathways, quality systems or component designs. It’s tempting to try to jump milestones, but there is almost zero benefit in the end and having to backup can be hugely expensive especially if you’ve got staff on payroll. It’s like trying to put the toothpaste back into the tube, it can be done but it is quite challenging.

 

Most of what’s in regulatory requirements for medical devices is simply best practices for running a good business. If you want to produce a quality product your customers will love, you need to clearly define user inputs in design, specifications for raw materials and shipping to name a few. Putting everything in its right place early, backed by a proven, phase-gated commercialization process supports a healthy business primed for growth and quality product for your users.

 

Get in touch.

GCMI is fully committed to our customers’ success and welcomes you to contact us at any point in a technology’s pathway from the ‘back of the napkin’ to the bench, manufacturing, bedside and beyond. Whether you’re an individual innovator, startup or health system with an internal innovation program, initiative or ecosystem, get in touch. It’s never too early.

“Based on deep experience and variety in products supported, GCMI knows the requirements for commercialization across the breadth and depth of new medical technologies from the simplest to the most complex. But they know what’s even more important. They know what a technology needs to be within those requirements to actually be successful in the clinic and in the market. They ensured we designed and built-in usability from Day One. This has had huge benefits. Its straightforward nature and user friendliness are two key reasons GloShield has had solid adoption and sales to date.” – Kamil Makhnejia, Chief Operating Officer & VP of Clinical Development, Jackson Medical

Get in touch and start the conversation via the form below. It’s never too soon.