Integrating Product Stewardship at Abbott Vascular

Product stewardship is not a standalone function. It works best when it’s integrated throughout the company. Kathleen Hall, group leader at Abbott Vascular, talked about the division’s trajectory toward an integrated program.

The product stewardship program at Abbott Vascular includes six pillars: product parts and packaging evaluation, chemical evaluation, conflict minerals, supplier communications, emerging issues, and extended producer responsibility (EPR).

As part of the design control process, R&D submits a list of materials it wants to use. When there are changes to existing products, they’re routed through product stewardship so the group can determine whether the materials are part of their restricted substances list. “We closed that loop for new products as well as existing products,” said Hall.

The product stewardship group categorizes substances in three groups: critical use only, discouraged and vulnerable. Substances in the first category undergo a risk assessment. Chemicals that are considered vulnerable are on candidate lists or targets of NGO advocacy. They’re either designed out or watched carefully. They may undergo a risk evaluation to determine the long-term defensibility, the value of use versus the cost of future reformulation and so on. Also important is whether replacing the substance will cause a performance issue. After the evaluation is completed, you determine whether to reformulate and move away from the chemical or continue to use it.

Gathering Composition Data

Hall said it’s a challenge to obtain 100 percent material composition data from suppliers, which affects the risk evaluation. They’ve begun including the request in agreements so suppliers know it’s a requirement to do business with them. They’ve also signed NDAs in cases where 100 percent composition data was absolutely necessary. “It’s not the least expensive option, but it’s an option nonetheless,” said Hall. The company will also test materials, especially in new product development, to determine chemical exposure in their products.

Tools Keep It Together

A different challenge is the growing number of regulations and chemicals of concern. For medical devices specifically, Hall said it can be confusing to know which regulations and chemicals to worry about. To work it out, the company hired a consultant to list all applicable regulations, along with the relevant chemicals and their restrictions.

The list is formatted as a color-coded spreadsheet that indicates the risk level, with categories like “concern,” “trending towards restriction” and “restriction.” Listings of chemicals are sortable by geography, regulatory listing, and hazard and restriction risk. The tool also links to the relevant regulations. Another benefit is that the tool is accessible to stakeholders who don’t work in product stewardship. They can look up a chemical and get the information directly without necessarily having to contact the product stewards.

A new system also makes tracking material information more efficient. Different departments organized the information differently at their local level. Now the company integrates the corporate database so that users can see if materials are being used in a different product already. “It was important for us to be able to pull information that we already know,” said Hall, instead of having to go back to suppliers.


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