Life cycle assessment is a useful tool for manufacturers as they become more accountable for the effect they have on the environment.

This column is based on an article which appeared as Designing sustainable medical devices in the July 2009 issue (volume 31, number 7) of MDDI, the magazine of the Medical Device & Diagnostic Industry.

Stakeholders in the medical device manufacturing industry are becoming more concerned about the environmental impact of their products and processes. These effects range from the potential negative effects of substances such as phthalate plasticizers leached from plastic products to emissions resulting from the incineration of disposed products. In addition, consumers are also becoming more aware of the negative impact that manufacturers can have on the environment. To combat such effects, consumer advocacy groups are demanding products that are more sustainable.

Sustainability as a competitive advantage

Government initiatives continue to increase environmental awareness through the development of new policy and legislation. This in turn is encouraging industry to become more accountable for the environmental impact of their products and operations. For example, the Waste Electrical & Electronic Equipment (WEEE) Directive and the Producer Responsibility Obligations (Packaging Waste) regulations of 2008 have set precedents regarding end-of-life disposal of products involved in their industries. It is only a matter of time before regulatory bodies start initiating changes in policy for other manufacturing sectors. Such regulations could well make it more difficult for companies to develop new products, at least in the short term.

 In such competitive environments, new product development can no longer rely solely on traditional criteria such as cost, quality and delivery. Effective environmentally sensitive product design enables manufacturers to gain a prominent competitive advantage in the development of “green” products. As a result, more and more businesses are adopting environmental management systems to organize and assess environmental effects, and meet the growing demand from consumers and legislation for green products.

 The ISO 14001 standard, “Environmental Management Systems–Requirements with Guidance for Use” sets guidelines to enable businesses to recognize the environmental effects of their products and processes. In order to qualify for ISO 14001 accreditation, a company must identify its overall environmental impact and determine the significant effects of its various products, while also demonstrating continual improvement in its manufacturing processes.

Life cycle assessment

Life cycle assessment (LCA) is a useful technique to evaluate the environmental impact of products, identify problem areas, and make improvements at the most effective stage of a product’s life cycle. Various studies have shown the benefits of performing a LCA at the product design stage to effectively lower a product’s overall negative environmental effect.

One tool used to make such an assessment is a LCA software packaged called SimaPro. It uses Eco-Indicator LCA methodology to aid manufacturers in selecting the most environmentally suitable materials for its products. The Eco-Indicator method provides impact assessment and ecodesign scoring. While there is no doubt that a detailed LCA is an extremely useful method for environmental impact evaluation, it can be costly and time-consuming, and the results can be difficult to convey to nonexperts such as consumer and environmental advocacy groups.

In-house web-based tool

Although there are various LCA software available, they can be difficult to use on a large range of products. The user must have prior knowledge of LCA inventory databases and internal product details before starting an LCA. The information needs to be entered manually into the program for each each product. The process is time-consuming and usually needs to be carried out by an experienced LCA practitioner. In some cases, materials used in a given product may or may not be present in the LCA inventory. This means the assessor now has to choose the closest substitute. This can introduce error into the results of the assessment.

 Some companies are working their way around these challenges by innovating new approaches. For instance, a manufacturer of a single-use respiratory-care device has developed an in-house tool that performs a streamlined LCA on products using existing company data to obtain an immediate environmental impact score for any product it manufactures. Internally, although the tool was developed to aid in the design process, it also has value in other departments, because the system provides a baseline score that enables product comparisons.

 Departments can use the tool to set targets to lower a specific product’s environmental impact and identify areas of high environmental concern when designing, purchasing, and marketing products. Once widespread, such a tool would aid manufacturers in the decision-making process. The following example is a real-lfie scenario of how manufacturers can develop a similar tool to aid designers in developing more sustainable products.

 One company stored information relating to its products in standard structure query language databases managed by Efacs, an electronic database and software program. The Efacs system was used to organize the company’s data and contained features such as the bill of material (BOM) for each product. Each product BOM provided detailed information on the product and was organized in a hierachical structure. Information included all components, subcomponents, and even specified packaging in terms of weights and materials involved.
 

Gathering environmental data

The company used LCA software to collect the environmental data for the scoring tool and chose the EcoIndicator 99 methodology. The process involved creating a project within the scoring tool that calculated an environmental impact score for all materials and processes. It also incorporated the required disposal scenarios of landfill or incineration. The figures were stored in a separate material scores table.

The first step involved collecting a list of all the materials and finding them (or the most appropriate substitutes) within the scoring tool databases. The next step involved calculating the environmental impact using Edo-Indicator 99 methodology.

Because the scoring tool is Web based, users have easy access to the data. The user can type any component part or product code that the company manufactures into the tool. Once the part code is entered, the scoring tool must read data from the BOM. The results of the BOM is dsiplayed in the table, showing part number, description of the part, material number, description of the material, generic material type, and weight of the material. The system then calculates the total quantity of each material used for each part (if more than one is used). The tool displays a dropdown menu for each material so that materials can be changed, and the button to calculate the score is activated only once all the fields are completed.

When calculating the score, the tool gets information from the populated scores table by multiplying quantities with score values. The results are then summed for each selected product and displayed in a report for landfill and incineration disposal scenarios.

 The simple-to-use Web-based tool enables the streamlined LCA of a product to be carried out in as little as two steps. This is important, because in order to design a more sustainable product, the designer needs to benchmark the existing product. New product designs are usually based on products already in production. The first use of the tool is to score the existing product to provide a benchmark. Once a benchmark is set, targets can be determined and improvements can be recognized. Because the products are made of components and subcomponents, the tool can change the materials and weights based on these. Any changes are reflected in the scores that can be compared side-by-side with the benchmark.

 The tool also has dynamic features that allow designers to change and compare products in five steps. The designer can also view product BOMs, add new components or remove existing components, change materials alter the weights involved, and compare the environmental impact of designs side-by-side. All the design ideas can be saved to a file for future reference.

Challenges remain but the course is set

The environmental scoring tool achieved the objective of quick and accurate impact scores for existing products, setting the benchmark to design more-sustainable products. Error is greatly reduced when comparing products because the environmental impact scores for selected materials have already been decided. Having access to such data precludes the need for the user to have prior knowledge of the environmental effects of different materials and products. These features mean the tool can be used by nonexperts of environmental LCA and provide accurate results, unlike traditional LCA software. The scoring tool also runs from a live database that eliminates error associated with incorrect data input, and products can be scored in seconds rather than hours.

As is often the case when it comes to manufacturing considerations, the medical device industry poses special challenges with regards to environmental issues. Medical devices involve additional environmental factors that have not yet been taken into account in generating an environmental impact score at this early assessment stage. For example, the additional environmental impact associated with the leaching of phthalate plasticizers from plastics. There are also the effects of product sterilization (of which a variety of techniques are used) before and after use, which have not yet been included. These processes and others like them will have to be added at a later stage

Another important limitation is the lack of available environmental data for thermoplastics elastomers and biopolymer materials, which may end up being used in future products. Estimates, however can be made by manually performing an LCA using existing data on raw materials and processes. Research in these areas will be used to develop the environmental scoring tool to aid in designing future sustainable medical devices. The process has really only just begun. A whole new generation of greener, more environmentally benign products will definitely see the light of day.