AOAC BOD June 2018 Pre-Meeting Materials

II. 2018 Business Plan Progress Q2 F. Sustainability: New Product/Revenue Streams

Top 8 New Products Ideas 1. AOAC RI Consulting Services

Background The Performance Tested Methods (PTM) program relies on the same technical guidelines used for the Official Methods SM program. However, the guidelines are general, and need to be applied to each test kit claims. This can be a difficult and time-consuming task for a test kit company, especially for a test kit company that has not been involved with AOAC before attempting an application. The AOAC Research Institute created a consulting program about 15 years ago to assist test kit companies to design their individual validation packages for PTM application. The program was well-received and has been very successful. Potential PTM applicants are offered a consulting service and are matched up with one of four or five AOAC contract consultants. The consulting service is not a requirement, but most (≈ 90%) PTM applicants choose to use the service. PTM- applicants can choose a flat fee of $3000 or choose to pay-by-the-hour for additional work. The applicant gets an approved PTM testing protocol based on their test kit claims. The flat fee and guaranteed approval of the test design are a huge draw. Some companies have spent much more money to design their own testing protocols which were then used to collect data (very expensive) which wasn’t acceptable to AOACRI reviewers (even more expensive since the PTM application fee were paid). Even more important to most test kit companies, delays to the approval timeline impacts their marketing campaign which are often predicated on obtaining the approved PTM certification mark. The consulting service program has many other benefits. It helps to streamline PTM reviews since the data packages are correct to start with. The consulting service program also builds a connection between the test kit company and AOACRI, leading to a more cooperative relationship with the goal of getting the fairest evaluation of a test kit. The AOACRI consulting service serves as a gateway for PTM applications and is priced to create the smallest possible financial barrier (cheap) on the premise that the service allows a company to “dip their toe into the water,” and then know what will be required to follow through. This builds customer confidence and trust. The pricing also recognizes that providing a low starting cost increases the number of complete PTM applications ($15,000) and even more importantly, many years of recertification income (usually 5 – 15 years at $3000 per year to renew). The consulting services program directly generates about $100,000/ year of break-even income. However, for every additional PTM application with ten years of recertification, the consulting service attracts income of $45,000.

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