When it comes to molding a medical device component, thorough preparation is of the utmost importance. This requires that the medical device firm has the best-possible team in place--both internally and in terms of the suppliers they do business with, says Phil Katen, the president of Plastikos (Erie, PA), an injection molder offering tight-tolerance parts for the medical and electronics industries that works hand in hand with sister company Micro Mold, a mold-maker. 

MPMN: What strategies work best to ensure that the proper material is being selected for a molded medical device component?

Katen: The medical device OEMs strive to find a fairly common, readily available (off-the-shelf) grade. If at all possible, steer away from custom grades. Price is one reason for this. More custom blends can drive the material's price up and the availability could be a question depending on how much of that grade the raw material supplier sells.

Here's a specific example: One of our customers is a global medical device company. They had a transfer project with a spec'ed out niche grade material. We reached out to material supplier to get that custom grade as there was only one source that produces and sells it. It came to light that only two companies were using that specific grade of custom grade raw material. The other customer that used this material, their demand dropped. And the price of the material went up approximately by 50% as a result of that.

The other part was that the company offering this material had jacked up the minimum order quantity for it. The minimum you could order was a rail car, which have lasted us 500 years or even longer. That was beyond crazy.

Our customer found themselves in between a rock and a hard place. They had written agreements that precluded them from switching material. They were in a near impossible position. We were able to work with the raw material supplier and get one gaylord of material from that other user of material--I believe in Europe--that would last for about two years of production.

Our customer looked at their clients that used those components and worked to requalify the device using an alternate grade of material. It was a slightly different grade that was much more common. No one knew why the exoctic grade was spec'ed initially. The material performed well and met all of the performance and testing requirements, but it was a very time consuming and stressful process to find enough for manufacturing. This was driven by the fact that once something is qualified in production, it is very difficult to change it down the road.

This goes back to getting the experience of a cross disciplinary team to select that material to meet the requirements and to make sure that it is readily available now and in the future and that it can be processed very well by the molder. When OEMs do that, they set themselves up for the greatest chance of success.

MPMN: How can medical device companies ensure that their components conform to Advanced Scientific Molding principles?

Katen: Any medtech company definitely needs to perform their due diligence up front and seek out the best suppliers. Throughout the process, they should periodically reevaluate those suppliers to make sure their standards are being met. It comes down largely to selecting the right suppliers up front. The OEM or any company should seek out the very best suppliers available and treat them as a strategic asset. Actions speak louder than words.

One of our global medtech partners not only talks the talks but walks the walks. They tell us that they view us as a strategic asset and don't want their customers to know we are doing business with them. They don't want their competitors to gain the advantage.

In the relationship between the device OEM and its strategic partners, a positive mindset is key--I would argue essential. The supplier should be viewed very much as part of the team. Some companies view their suppliers as a necessary evil or a line item with the goal to continuously reduce that cost. You can tell pretty quickly whether engineering and quality really drives the company or if it is finance and accounting driven. You can tell who has the decision-making authority.

Here at Plastikos, I will be the first to state that it is our goal to retain and recruit the best people from entry people to managers. Both at Micromold and Plastikos, we stack our team with all stars throughout the organization. ... It makes it rewarding to work with winners. This is the same as with our suppliers. The companies that help us maintain our facility are the very best. We put the best team on the field.

That same vision can and should be applied by medical device OEMs when they are doing their due diligence and looking for suppliers. In the medical industry, open honest communication is key to success.

True partnership is key to collaboration. In reality, we work together towards common goals. The most successful projects were viewed as though they were employees of the OEM company. Of course, we are not, but that mindset is really key.

On the flipside, there are other companies that talk the talk but may not walk the walk. They may cut corners on tooling or push us to got to low-cost tooling sources. ... The wrong perspective is that we should cut costs. It is ultimately putting the team on shaky ground at best if not a near impossible position. ...

Another case that doesn't lead to a good collaboration is when an OEM comes to an injection molder in a competitive quoting process and asks the molder to reduce the cost of the project. That doesn't strike the right tone. It is different if the engineers at the company has an idea of using alternate materials or eliminating features that would reduce the overall cost of a project.

It goes back to that perspective of treating everyone as if they are on the same team. Treat the supplier's team as as your employees.

It is also important to watch out for mixed messages--both verbal or written.

Once we had a meeting with a supplier manager who gave us all-around positive accolades for the past three years we had been running production of the mold. He said good things about the team and visibility throughout the production. Then, 5 minutes later we move onto the next project, he leads it off with a suggestion to work with low-cost tooling suppliers. This was 180 degrees different than what we just talked about. How can we do a good job when we have C- or D-quality players in the mix?

The further you venture from home to get low cost, the frequency of problems tends to increase. Even domestically, there are poor companies that don't have the engineering or technical capabilities to deliver for their customers.

Ensuring that you are working with a company that has a solid grasp on Advanced Scientific Molding principles goes back to that due diligence. Don't just take their word for what they say. If they are implementing cutting-edge technology, they should be able to show you examples of that. They should be able back it up with proof. Every one of our partners does a manufacturing / engineering audit. In some cases, there are concrete proven examples that back up the claims we make and demonstrate that we live the principles we strive for every day.

MPMN: About two years ago, you wrote a column reflecting on the intersection of the electronics and medical device industries. If anything, those two industries are cross-pollinating now more than they were then. What advice would you have for medical device companies designing consumer-inspired products?

Katen: I think ... you touched on a great topic. You see more devices weave in high tech electronics. You are seeing devices pushed into the home and outside of the home--into the sphere of life. Performance is critical for these products.

The other element is the elegant design that we are seeing more devices take on. Devices are being pushed out into the world at large. Life pushes a lot onto people every day. Devices have to be rugged and durable and as error-proof as possible in their end use. On the flip side, they should be easy to use.

The other element is that elegant simple design. If it has electronic components, it has to feel right. I am a big fan of Apple. The iPod through the iPhone and iPad are groundbreaking products. When you get an Apple device, even the box was thought out and well designed. Attention to detail was put in by the designers. The look and fit was just right. Apple notoriously is known for simple, easy to use, largely intuitive devices. ...

That is really where electronic devices and medical devices--and the intersection--is continuing to go. At Apple, from one generation to the next, the original versions that were so innovative, compared with 2 or 3 more innovations, they look big and clunky. Even since then, you continue to see that design evolution that makes them more seamless and elegant.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. 

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