By Design: Issues facing medical product designers

Few vocations are as rewarding as helping those who are ill, but critical 
know-how must be passed along to each generation.

The use of plastics benefits mankind in countless ways. Many of the most impressive are in the healthcare field, where they increase longevity and enhance the quality of life. There are countless examples of this. One of the most important is the reduction in the spread of infection. Plastic’s ability to reduce cost allowed single-use items to replace devices that were previously cleaned, sterilized, and reused.

I had the good fortune to work at Abbott Laboratories from 1958-1968. That was when reusable glass, stainless steel, rubber, and nickel-plated brass were being replaced with single-use thermoplastic. I was part of a group hired to develop Abbott’s line of disposable plastic products. At that time universities didn’t teach biomedical engineering or plastics technology. None of us knew much about plastics. Fortunately, we had good mentors and excellent suppliers. We determined what was needed and the suppliers figured out how to make it. The system worked well.

Challenging opportunities
Our objective back then was to stamp out disease, stop suffering, prolong life, and make a profit. It was a rewarding time to be working in that field. Today’s medical product designers are being told to make a profit and then stamp out disease, stop suffering, and prolong life.

The emphasis has changed, but there are still many opportunities to design products that benefit mankind. To name a few, moldable-bioresorbable polymers are pioneering new uses. There is a need for highly reliable, easy-to-use self-diagnostic and home-treatment products. Robotic and minimally invasive surgery has created more demand for  micromolded parts. An unacceptable number of deaths are being traced to hospital errors. Designing failure-proof products can reduce these fatalities.
There are many opportunities, but the challenges are greater today than they were in the 1960s. There are more regulations that limit design freedom. Today’s non-technical managers interpret regulations as the worst-case scenario. They don’t understand the technology and cannot evaluate the competence of their staff. This results in excessive testing.

The big OEMs now hire more quality assurance PhDs and fewer engineers. Designers spend too much time in meetings playing what-if war games. Support staffs have been reduced and engineers devote valuable time to performing routine tests, typing reports, filling out forms, and running their own photocopies.

Costs vs. profits
Healthcare OEMs always wanted low-cost plastic components. They used to be willing to pay a little more in order to attract the best suppliers. Times have changed. There is now greater pressure to reduce costs, which is a metaphor for increasing profits. OEMs, insurance companies, and caregivers are going to take full advantage of President Obama’s new healthcare legislation to increase profits.

There are still opportunities to design products that benefit mankind, but only if the cost is kept to a minimum. For example, hospitals want products that reduce labor and human error; however, they aren’t willing to pay any more. Designing useful products, while meeting all of the regulatory requirements at the lowest possible cost, requires a thorough knowledge of the plastics manufacturing processes. The medical plastics designer’s greatest challenge today is the lack of technical competence in this area.

Product designers come from many disciplines, but the majority are mechanical engineers. In the United States there are more than 200 universities graduating mechanical engineers. Less than two dozen teach plastics technology. It was the same in 1958 when Abbott’s little group of novice engineers started designing disposable products. What was different then was that we had good mentors who taught us what we needed to know.

Vanishing experience
The managers at most large medical OEMs have little appreciation for the importance of experience in designing and developing new products. They have long ago replaced their experienced designers with less-costly young engineers. Fortunately, startup companies and privately held smaller hospital equipment manufacturers respect abilities gained through experience. It is these companies that are providing much of today’s creative breakthrough product designs.

The number of different plastics manufacturing processes and materials continues to increase. Some products can be made by more than one process. Designers must be familiar with the capabilities and limitations of processes such as blowmolding, thermoforming, rotational molding, extrusion, injection molding, and others. Within injection molding, there are specialty processes such as gas assist, multimaterial, structural foam, micromolding, LSR, assembly molding, inmold labeling, and so forth. Each of these materials and processes has its own unique part design requirements. It takes years to learn how to design parts for all of the possible material and process combinations.

It is not uncommon to use more than one process and material in a single product. The Hospira iSecure syringe seen at the left uses multishot and assembly molding with low-density polyethylene, copolyester, and polypropylene to produce four different parts in one mold. This syringe requires knowledge of the type that can only be learned by experience.

A return to trial and error
Today many medical products are designed and developed by engineers with little or no training in plastics technology. For many of them, this is their first job after graduating. Most did not learn plastics technology at their universities. With no mentors to teach them, these young designers are left on their own to learn by the slow and costly process of trial and error.

Once again, medical product designers are turning to their suppliers for part design and manufacturing know-how. The sophisticated mold for the Hospira syringe was designed and built by KTW Group (Waidhofen Austria), and the complex molding is done by MGS Mfg. Group–Antioch, IL. Everyone involved agrees that the success of the syringe is due to the knowledge and prior experience of the two suppliers and their close cooperation with the Hospira engineers.

Most young medical plastics designers will continue to rely on their suppliers for technical know-how, while they gain experience. This is as it should be, but there are problems. The medical plastics industry is a relatively recession-proof market. Many plastics processors are now trying to enter this field as their other markets decline. They may be low bidders, but they can’t provide the same service and technical support as suppliers with years of medical plastics experience.

Commodity healthcare plastic components are being produced offshore. This practice will continue and include increasingly demanding components as OEMs develop confidence in their non-U.S. sources. Yet communicating with these offshore suppliers can be difficult and fraught with many opportunities for misunderstandings. Most of these suppliers cannot be relied upon to provide the same service and technical support as their U.S.-based competitors.

The Hospira syringe won the 2009 International Plastics Design Competition’s Medical Award and went on to receive the Industrial Designers Society of America/Plastics News Design Award. The current practice of close cooperation between product designers and their suppliers is producing impressive, clinically acceptable, award-winning products.

I find it interesting that Hospira Inc. is a spin-off company of the same Abbott Laboratories that I started working for in 1958. Many things have changed, but designers still have a personally rewarding opportunity to create plastic medical products that benefit mankind. —[email protected]