Keeping Sales Compliant in a Highly Regulated Industry
An international manufacturer with a significant U.S. presence
A manufacturer operating in the highly regulated environment of medical device sales needed a set of contract templates and a compliance guidance to ensure its sales force entered into legally compliant sales arrangements.
The client’s legal and compliance team wanted to ensure that sales contracts involving discounts, rebates or other valuable consideration for its medical devices complied with certain federal laws that are a frequent area of government enforcement in the healthcare industry. The client was concerned, however, that its sales force would not use a long-form contract template with legal ease requiring that we be creative in developing a short form with attachments that could be appropriately incorporated and executed.
We created a set of templates to cover key product lines. We included one or more templates for each product line depending on how the product was typically placed with customers. We created a table of contents with a brief description of each contract template and when to use it. We also created a contract compliance chart to guide the sales force on compliant discounts, rebates, rentals, equipment loans, product samples and other offers of value to the customer. We used 7-Zip to link and zip the table of contents, templates and compliance chart into one neat package.
To ensure that the resulting product was both relevant and workable considering the actual dynamics of the sales process, we worked closely with the client’s representatives throughout the development of the templates and compliance chart. The resulting contract templates accompanied by compliance guidance enabled the client to not only enhance its compliance training and education in a highly regulated marketplace but also provided the client with actual tools via the templates to achieve compliance. The compliance chart was designed so that it could be used by the sales force to achieve compliance even when using the customer’s own contract template.