What To Expect When You Move Into Production For The First Time

By Jim Kasic, Boulder iQ

No matter how hard you try, how strong your processes are, or even how good your prototype is, when you transfer a device into production, it’s a bit like a Sunday morning when you decide to make omelets. No matter how prepared you are, the first one never turns out well. The second is better. By the third try, it’s usually starting to look like what you want. Then you’re off and running…er, cooking.

Taking a medical device into production bears some similarities to omelet-making. Medical device developers are often surprised to find that things don’t go quite as they planned the first (or second or fifth…) time around. Here, we look at what to really expect when you take your device into manufacturing.

Accept That There Will Be Learning Curves

There’s a learning curve to everything. For medical devices, one major curve stems from the typical progression from design to production. Most companies — of any size — usually have one team that designs the device and another that is responsible for manufacturing the device. What the design team expects to be a finished device often isn’t what the manufacturing team considers to be a finished device.

A recent project my company worked on offers a quick example. The developer delivered a device it considered ready for manufacture. While it could be manufactured, the design required hours of soldering on every device’s circuit board. The time commitment and requirement for precision made manufacturing impractical at best. Yet just one more revision to the circuit board produced a solution that took seconds instead of hours to complete.

Another example of the learning curve that often results from different perspectives occurs with instructions. Based on what they’ve designed, design engineers often will write the instructions for assembly workers. Yet no matter how hard they try, they often can’t communicate the instructions well enough on the first try.

You’ll Need To Troubleshoot

What to do? Accept that you’ll face a learning curve in every step of your manufacturing process and that mistakes are inevitable parts of every learning curve. You’ll also find that it’s very rare that things move as fast or efficiently as you’d like. Costs won’t be as low as planned, a certain procedure is less efficient than predicted, or a key part of the process may even have been left out.

None of these things are deal-breakers. They are, though, obstacles that you’ll need to address. Troubleshooting need not be a disruptive process but, rather, something that takes place systematically and methodically. Development of analysis skills, with an eye on optimal performance, is important for every good medical device development group. Prepare your teams to expect learning curves, to take mistakes and missteps in stride, and to work collaboratively in pursuit of smart solutions.

Balancing Design For Manufacturing With Speed To Market

There’s no doubt that getting your device to market as quicky possible is important, but expect to find yourself negotiating a careful balance between rushing to market and optimizing your manufacturing. If you’re rushing to market at the lowest possible cost, chances are high that you’ll drive the manufacturing price up, far beyond your cost predictions or budget.

Design for manufacturing (DFM) refers to the process of designing for ease of manufacturing, with the goal to make a better device more easily and at a lower cost. While it’s possible to spend infinite time refining a device’s design, the idea is to utilize best practices with that stated goal foremost in mind.

Large and small companies alike will often design a device that works and meets the stated risk profile and which users have indicated in research that they like and will use. But all of that does not mean the device can be manufactured in a timely or cost-effective way.

A case involving catheter tubing helps to illustrate the point. If you had a vendor supply all your tubing at the exact lengths you needed, you could eliminate the process of cutting the tubing. You’d simplify manufacturing and decrease costs by cutting out a process. That would be pure DFM.

But, during the development process, since you did not yet know exactly what lengths of tubing you needed where, you probably purchased a large quantity of tubing at a long length and then cut it to the lengths needed. If you were to follow DFM principles, you would dispose of any extra-long-length tubing and order the lengths you now know you need. Would that make sense? For many companies, the answer is no. But you would need to look at the total cost and time involved to make the right call.

The other unknown in medical device development is the salability of the device. A consumer products manufacturer might be able to easily incorporate DFM into an established product without major concerns. With a product that will generate $100 million in revenue, spending $20,000 to optimize a mold for snap fits, for example, is a simple decision; they know it will save money in the long run.

But often, in medical device development, you don’t really know how a device will sell. Deciding to spend $20,000 to optimize the manufacturing process may not always be the right decision. Instead, to speed your device to market and start generating that revenue, maybe the right decision is to hold it together with screws instead of snap fits. They take longer to install but are significantly less expensive.

Expect to be constantly optimizing for both time and budget, analyzing costs and benefits, and understanding that sometimes, DFM won’t be the right decision at the moment.

Don’t Catch The Band-Aid Syndrome

More often than not, in early manufacturing stages, the Band-Aid syndrome takes hold. When a problem arises, companies will opt to put a Band-Aid on it instead of fixing the root problem. This is usually a decision based not on neglect or a deliberate attempt to cut corners but on short-term time and cost — and one that is, to use an old adage, penny wise and pound foolish. While saving a small amount of money in the short term, a developer can end up spending significantly more in the long term.

As an example, consider a device designed without a connector. Instead, six wires went from the circuit board to switches, lights, the motor, and the motor controller. To hurry the device to market, the interim solution was soldering every wire. In the next iteration, the developer designed a plug that eliminated the need to solder. But they were moving so fast that they reversed the wires. The next fix was to modify another part to make the device work with the reversed wires. In the end, the device worked, but in a way that was not at all practical for manufacturing. What the company really needed to do was make design changes on the full device instead of just one piece. It would have cost more – in time and money – over the short term, but in the medium and longer term, it would have been the right decision.

The Third — Or Sixth — Omelet

In the kitchen, the magic number to get to steady-state omelet production may be three. In medical device development, it’s usually six to reach a steady state. Opportunities to improve and become more efficient will present after that point, but that is generally where to expect a steady rate of production.

Even if the device has been designed for manufacturing, in those first few lots you will find things that can help you assemble faster or make a better device. You’ll find issues that tell you a device isn’t ready for cost-efficient, full-scale production – even if, like the soldering example above, manufacturing is possible. And you’ll be able to zero in on the long-term cost of manufacturing at that point.

Accept What You Can — And Can’t — Control

Understand that some issues – like learning curves and taking a half-dozen lots to get to steady state – are just going to be part of the process. You’ll also benefit from understanding that you will constantly be optimizing for function, time, and cost. But unless you have an infinite amount of time and money, you have to do your best.

Stepping into manufacturing means accepting that you’ll never think of everything from the beginning and that some factors are out of your control. One area over which you do have control is the manufacturing contractor you select. Work with experts who have extensive experience in taking new medical devices into manufacturing, who know what to expect, and who can spot problems early on if not before they occur. They will know how to properly analyze a cost/benefit decision, when a design change will be the right move, and what types of steps you can take to speed your device to market.

About The Author:

Jim Kasic is the founder and chairman of Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patents. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a B.S. in physics and an M.S. in chemical/biological engineering from the University of Colorado, and an MBA from the University of Phoenix. He can be reached at jim.kasic@boulderiq.com or on LinkedIn.