Chris Kadamus

Medical products account for an enormous amount of the solid, industrial, and chemical waste in developed countries throughout the world. In the U.S. alone, hospitals produce more than 6,600 tons of waste per day, including 800 tons of non-hazardous, and potentially recyclable, plastic parts. In addition, many medical products use hazardous chemicals and solvents during manufacture or include materials that can be harmful if not disposed of properly. Disposal of non-hazardous and hazardous medical waste can be costly from an environmental and financial point of view. As such, it could benefit the medical-device industry to embrace sustainable design, a concept in which products are evaluated in terms of financial impact and social and environmental impact as well.

Historically, the medical-device industry as a whole has been risk averse. This is primarily because of stringent FDA regulations, fear that alternate methods or materials may compromise patient health, and an overarching fear of legal liability. Adding design for sustainability to an already rigorous set of design requirements, including biocompatibility and aseptic assembly, can put an additional burden on design teams whose primary goals are time-to-market and FDA compliance.

Furthermore, much of the medical-device industry generates most of their revenue from disposable products. Approximately 90% of medical-device waste consists of items designated for one-time use. Fears of contamination, the high costs of sterilization and reprocessing, and the desire for continuous revenue have firmly anchored the disposable products' business model in the minds of industry leaders.

There are, however, a number of driving factors and significant competitive advantages in bringing sustainable design to the medical-device industry. First, while the U.S. has lagged in the ratification of environment legislation, the European Union has moved to ban some hazardous materials, promote recycling and encourage energy efficiency using legislation. Standards such as WEEE (Directive on Waste Electrical and Electronic Equipment), RoHS (Restriction of Hazardous Substances in Electrical and Electronic Equipment), REACH (Registration, Evaluation and Authorization of Chemicals), and the EuP regulations (Energy Using Products), while not currently applicable to the U.S. or enforced for many medical products, have gained significant support in recent years. Many experts agree it is only a matter of time before these or similar standards will be enacted in the U.S. and become applicable to the medical-device industry.

Forward-thinking companies that prepare their products to meet these standards will have a significant advantage over companies that will be forced to scramble and retrofit products to comply with new legislation. Staying ahead of the regulations can decrease long-term costs.

In the U.S., Group Purchasing Organizations (GPOs) and other large hospital conglomerates are encouraging the use of healthier, environmentally friendly medical products. Many GPOs see public-relations advantages in supporting good environmental citizenship, in addition to opportunities for reducing waste. Consequently, the demand for mercury-free, PVC-free, and lead-free products, as well as products that conform to EU standards has grown.

In addition to driving factors from outside entities, there are financial gains to be made by moving to sustainable design and manufacturing. Proactive design for sustainability at the concept level helps reduce waste, packaging, and shipping costs. It also improves manufacturing efficiency and use of raw materials. Tools such as lean manufacturing, Six Sigma, and Current Good Manufacturing Process (CGMP) promote process flexibility, zero-defect manufacturing, and eliminating over-production. While originally billed as cost-saving measures, these tools advocate the critical tenants of sustainable design.

There are many ways to improve sustainability of medical devices, but the key factor is design of a product lifecycle, not just a product. Lifecycle analysis tools such as manufacturing flowcharts, materials databases, environmental impact analysis tools such as Eco-Indictor 99, and software programs such as Eco-it and Simapro are available and can help in organizing formal environmental management systems.

Eco-Indicator 99 addresses the impact of products by breaking them down to elemental components, materials, and processes. Eco-it and Simapro software consider the effects of material choices and manufacturing processes, incorporating them into graphical and numeric representations to assist with design decisions.

Engineering concepts such as design for disassembly and recycling, minimizing dissimilar materials, and eliminating toxic and hazardous materials all promote the tenets of sustainability. By reducing product weight, packaging, and part counts, manufacturers cut material costs as well as fuel costs for transport. These concepts are most effective at improving sustainability and increasing profits if instilled in the engineering staff during product conception. Instituting sustainable design practices can yield environmentally friendly medical devices, and higher quality, lower-cost medical devices. Medical-device companies that understand the challenges and embrace sustainability prior to the development of industry environmental requirements will potentially have a competitive advantage.