Sustainability in Medical Device Design

Green can be profitable, if device manufacturers consider internal and external drivers.

September 1, 2008

11 Min Read
Sustainability in Medical Device Design

PRODUCT DEVELOPMENT INSIGHT

Chris Kadamus

The world is changing. Oil prices have surpassed $140 per barrel and phrases such as climate change, carbon footprint, and going green have become fixtures in the daily vernacular. Environmentally friendly design, sometimes called sustainable design or green design, has become a topic of great social and financial significance. Companies are beginning to discover the benefit and the necessity of buying and using more ecofriendly products and services.

Although the term green refers specifically to the environment, true sustainable design considers the social and financial effect on a product as well as its effect of the environment. From a designer or engineer's perspective, sustainable design takes the entire product life cycle into account, from creation to disposal, during the initial design of the product. The success of a product is measured by its ability to balance financial, environmental, and social factors.

Although consumer industries are promoting sustainable products as market differentiators and key selling points, application of sustainable design in the medical device industry has been slow to take hold. In a market in which direct consumer contact is infrequent, the value of environmentally friendly products as public relations tools is reduced. Without a measurable public relations benefit or a definitive path to financial gain, it may seem unlikely that the medical device industry would embrace green business. There are, however, a number of driving forces moving the industry toward sustainable design practices.

The External Push Toward Sustainability

The United States alone produces more than 6600 tn of medical waste per day, totaling well over 2 million tn a year. Although a portion of this waste is considered a biohazard and must be incinerated, approximately 85% of waste produced in healthcare facilities on a daily basis is nonhazardous.1 The average daily total of waste includes approximately 800 tn of nonhazardous and potentially recyclable plastic parts.2 In past decades, nearly all medical waste has been collected, combined, and incinerated, producing highly toxic air pollutants including dioxin, lead, and mercury. However, with the introduction of new regulations, rules, and purchaser preferences, many of the waste disposal methods of hospitals, and ultimately the design decisions of medical device manufacturers, will soon be changing.

For several years, regulations for the reduction of waste and minimization or elimination of hazardous substances have been enforced in the European Union (EU). Standards such as the Waste Electrical and Electronic Equipment (WEEE); Restriction on Hazardous Substances (RoHS); Registration, Evaluation, and Authorization of Chemicals (REACH); and the Energy Using Products (EuP) regulations have significantly altered the manufacturing processes of electronics at industrial and consumer products companies.

The WEEE Directive requires the use of specific labeling, compliance with disposal restrictions, and creation of instructions for end-of-life management and recycling. RoHS restricts the use of toxic metals, specifically mercury and lead, as well as certain flame-retardant materials from electronics manufacturing processes. REACH, implemented in 2007, established the regulation of more than 30,000 chemicals used across a myriad of industries. The EuP is currently voluntary, but the directive sets limits on the amount of energy that can be used during the life cycle of a product. Therefore manufacturers must calculate the energy usage for production, transport, use, and disposal of a product.

Disposable, one-time-use products, such as these syringes, make up about 90% of medical device waste.

Although many medical devices are currently exempt from these regulations, several directives, including RoHS and WEEE, are in the process of being reviewed and could be applicable in Europe within the next two years.3 Europe remains a key market for many medical device manufacturers. Loss of this market due to noncompliance with environmental regulations could be financially devastating.

Although similar legislation does not yet exist in the United States, pressure from a nondomestic customer base has already forced many U.S. companies to comply with WEEE and RoHS. In addition, many experts agree that the passage of stricter environmental directives in the United States is inevitable.

Voluntary compliance by medical device manufacturers with European directives such as WEEE and RoHS in the near term will reap significant savings once similar directives become mandatory. Companies that eliminate banned chemicals, reduce power consumption, and adopt RoHS-compliant electronics manufacturing processes now are likely to have an advantage over those forced to redesign and retrofit products to meet impending regulations.

Much of the U.S. healthcare system, including large hospitals and group purchasing organizations (GPOs), has begun to embrace sustainable practices as a smarter way to do business. Hospitals and GPOs are also recognizing that adopting sustainable practices can greatly reduce operating costs.

According to the advocacy group Hospitals for a Healthy Environment, the cost for disposal of medical waste in 2000 was between $44 and $68 per ton.1 Producing more than 1 million tn of waste per year, healthcare facilities in the United States alone spend more than $130 million per year to move, store, and incinerate their waste. To curtail such costs, many hospitals and GPOs have adopted a preference for eco-friendly products, specifically PVC-free, mercury-free, and lead-free products. The significant buying power of both hospitals and GPOs will likely drive the medical device industry to reduce packaging materials, design products for disassembly and recyclability, and support end-of-life product reclamation programs.

Barriers to Sustainability

Approximately 90% of medical device waste consists of disposable, one-time-use products or components.4 Outside observers may think solving the problem is simply a matter of reducing the number of disposable components. However, many manufacturers find it difficult to do that from both a safety and a financial point of view. A significant portion of medical device manufacturers generate the bulk of their revenue from the sale of disposable products or components. Adherence to this business model is advanced by the risks associated with hazardous medical waste, biological contamination, and the high cost of product sterilization and reprocessing.

Waste by the Numbers

6600Tons of waste generated per day by hospitals in the United States$44–$68Cost per ton of waste disposal in hospitals per day85%Percentage of nonhazardous solid waste (food, metal, glass, etc.)

In addition to the trepidation regarding disposable versus reusable medical products, the sterilization process itself raises a number of environmental concerns. Indeed, several traditional sterilization modalities, including the use of glutaraldehyde and ethylene oxide, are inherently harmful to the environment and are often governed by strict disposal regulations. For these reasons, many hospitals and medical device companies are adopting less-toxic methods such as hydrogen plasma or autoclave.

In the highly regulated medical device industry, many manufacturers see the prospect of sustainable design as another design restriction. Engineers and designers focused on complying with strict FDA guidelines and meeting intense time-to-market pressures may perceive sustainable practices as hampering material choice and impeding innovation. The possibility of legal liability and lengthy product development cycles has also slowed the adoption of sustainable practices in the medical device industry.

Making Sustainable Design Work

Although the barriers to sustainable design in the medical device industry may seem significant, there are myriad methods for circumventing these obstacles and providing products that are both environmentally friendly and financially successful. Many of the key tenets of sustainable product design stem from understanding and developing a product life cycle, not just a product. The concept of product life cycle design considers all stages of product existence, including concept development, material selection, design and engineering, manufacturing, packaging, transportation, sales, use, and end-of-life disposal during the initial product planning stages. Each stage is evaluated from the perspectives of energy efficiency, environmental impact, material usage, human effort, and cost.

Performed correctly, product life cycle design can lead to significant improvements in manufacturing efficiency. It can also improve time to market, risk reduction, efficient material and energy usage, safety and regulatory compliance, and packaging and transportation costs.

A variety of formal product life cycle analysis tools are readily available, including software programs such as Eco-it and Sima­pro, and environmental impact analysis tools like Eco-Indictor 99. Such tools are designed to organize and evaluate data for the purpose of promoting informed design decisions, leading to efficient and effective products. Eco-it and Simapro address the positive and negative effects of the manufacturing process and material choice on product viability, cost and the environment, incorporating these factors into graphical and numeric representations. Eco-Indicator 99 evaluates products by deconstructing them into elemental components, materials, and processes, providing each with a damage score and using the aggregate to assess their respective effects on the environment.

In the absence of formal life cycle analysis tools, engineers can make use of checklists, spreadsheets, and flowcharts to map product life and gain a subtle understanding of the stages. Developing a materials database and cataloging applicable requirements and standards allows for easy access to pertinent information. Effective quality system requirements programs that are already in place per FDA regulations can be used to assist with tracking processes, materials, and waste. Meeting ISO 9000 requirements for quality management or going further to institute ISO 14000 (environmental management) can put management-backed emphasis on product life cycle consideration.

Methods such as Six Sigma and lean manufacturing promote low defect manufacturing and encourage process flexibility. Lean manufacturing specifically targets and attempts to reduce seven waste streams, namely overproduction, waiting time, transportation, processing, inventory, motion, and scrap. These concepts, while originally developed to improve efficiency and reduce production costs, also align with many of the goals of sustainable design and production.

Regulations for disposing of electronic waste are enforced in Europe and are voluntary in the United States. Compliance, however, makes good business sense for all device makers.

More specific to product design and engineering is a variety of sustainability improvement methods that can be applied to daily product development. Designing products for easy disassembly, minimizing bulky or nonessential packaging, reducing part count, moderating the use of dissimilar injection-molded materials and eliminating toxic or hazardous materials (lead and PVC, for instance) help to meet the goals for sustainable design as well as those for efficient, low-cost design. Reducing product size and weight and creating stackable or compact packaging can greatly reduce fuel consumption and decrease transport costs.

With respect to disposable medical products, choosing materials that limit environmental damage during disposal and incineration can reduce toxic air emissions and reduce waste processing costs. In addition, products that have a durable or reusable component and smaller disposable components can minimize waste without damaging the lucrative nature of the disposable device business model. The critical factor in the durable or disposable product concept is to create a simple, repeatable interface between the two component sections so as not to impair the functionality or efficacy of the product.

Conclusion

Sustainable design methods are most useful if instilled in the engineering staff during product conception. They are considerably more effective if product development begins with the goal of sustainability in mind. The life cycle of the product begins at the conceptual stage and thus sustainable design provides that greatest value when implemented at the start of development and reiterated as the product matures. Although it is certainly possible to retrofit and redesign existing products using these design methodologies, product life cycle engineering will provide the greatest cost and sustainability benefits if it becomes a company philosophy.

Impending environmental regulations, the high cost of waste disposal, and record fuel prices will begin pushing the medical device industry in the direction of sustainability. Device companies that choose to meet the challenge will likely see competitive benefits in the future, as competitors struggle to meet demand and comply with directives. Sustainable product design not only benefits the environment and society, but it also provides for long-term economic vitality.

Chris Kadamus is a principle design engineer at Cambridge Consultants in Cambridge, MA. He can be reached at [email protected].

References

1. “Waste Reduction: Why Focus on Waste,” [online] (Arlington, VA, Practice Greenhealth [cited 23 July 2008]) available from Internet: http://cms.h2e-online.org/ee/waste-reduction.

2. Jean Johnson, “Hospitals Going Green a Win-Win Move,” [online] (Cambridge, MA: Body1 Inc., 2006 [cited 23 July 2008]); available from Internet: http://www.medtech1.com/new_tech/newtechnologyfeature.cfm/237/11.

3. “RoHS Exemption for Medical Devices is Under Review” [online] (Green Supply Line, 2006 [cited 23 July 2008); available from Internet: www.greensupplyline.com/howto/192300282.

4. “An Environmental Guide for the Medical Device Industry of Massachusetts,” Commonwealth of Massachusetts Executive Office of Environmental Affairs (Boston: December 2006): 46.

Copyright ©2008 Medical Device & Diagnostic Industry

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like