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Moving forward, an early task to be done in December and January will be to provide support and encouragement to the Program Chair and Program Chair-Elect to begin the process of organizing Topic Contributed sessions and other activities (roundtable discussions, etc.) for the JSM 2012 in San Diego. I look forward to working with all the members of the Executive Committee. There will also need to be some advance work to make sure that we have a meeting room for our business meeting in San Diego. A challenge is to continue to make statisticians aware of this Interest Group and its activities. While the current membership is well over 100, I suspect that there is a great deal more interest in industry and academia for the unique statistical issues which studies of medical devices and diagnostic products pose. It may be possible to stir some interest in organizing one or more Invited Sessions for JSM in 2013 (and a Section to serve as Sponsor) and that would need to take place by the summer of 2012. A topic of discussion for the business meeting in San Diego may be whether there is interest within the Interest Group to move toward becoming a recognized Section within ASA. I would anticipate that there would be other activities that the membership might want to have the Interest Group be involved in and I would plan to help facilitate such activities. Towards the end of the 1 year some thought should be given to passing on to the next round of officers some idea of target dates for officers for the next year’s predicted activities."

In my role as Chair-Elect I would like to focus on three concepts. The first is to raise the profile of statistics within the medical device industry. The second is to push for innovative, scientifically strong, and flexible designs and analyses in medical device applications. Third, is to help build a strong community of statisticians with a focus in the medical device industry.

The role of statisticians in the medical field in general is typically minor. I think we need to be at the table when big decisions are made. Statisticians need to be drivers of designs and decisions. This problem is even worse within the medical device community. Given the industry environment with many small companies, there are many companies that don’t have professional statisticians. Many statisticians in the industry play minor roles of data management and routine analyses. There is a great opportunity and need for statisticians in the medical device industry. The industry is unique, providing many opportunities for innovation and leadership and many of these differences highlight important statistical concepts. There is an enormous need and opportunity for statisticians to lead.

In order for statisticians to be leaders in this industry it demands we lead by example. We must be innovators, we must help create good solutions, while maintaining high scientific standards—we must perform.

In order to become leaders and innovators in the medical device industry we need to provide a strong group of statisticians. The SIGMEDD group can provide a great structure to share ideas, create innovation as an industry, and provide opportunities to raise the profile of the statistics profession within the device industry."

The role for the program chair is to develop the technical program at statistics meetings. A good technical program requires a program chair who will seek out interesting topics and compelling speakers to form an exciting program. The program chair must also understand the rules and processes around the technical sessions to ensure the sessions are accepted. While JSM is an important venue and will receive my attention, smaller meetings will be of interest as well. The annual FDA-Industry Statistics Workshop is an example of a meeting at which SIGMEDD can have high visibility, in cooperation with the Workshop organizing committee. A presence on the technical program at other meetings, such as the ENAR Spring Meeting, is important to increase our visibility to students and others who are considering career paths but who are not familiar with medical devices and diagnostics.

Program chairs have other responsibilities than organizing technical programs at meetings. The officers of SIGMEDD, including the program chair, are important for conducting the business of the interest group. Such activities include membership retention and expansion, liaising with the ASA office, discussing areas of common interest with sections (notably the Biopharmaceutical Section) and potentially undertaking joint projects with other organizations or sections."

I would continue to work closely with statisticians from industry, academia and the FDA and enhance the collaboration. For example, as the FDA Co-Chair of FDA/Industry Statistics Workshop 2013, I would strive to increase the visibility of SIGMEDD and the involvement of statisticians from the medical devices and diagnostics. Within the FDA, I would drive to increase the transparency and predictability of regulatory pre-market statistical reviews, and promote the application of novel statistical methods and the appropriate use of statistics."

I’ll do my best to produce minutes at SIGMEDD Business meetings that reflect what transpired at the meetings. I’ll post the minutes promptly at the SIGMEDD website."