Experienced mechanical engineer with extensive history as a technical writer for the medical device and regulatory compliance fields. General technology writing experience as well.
Significant writing accomplishments:
•Provided over 30 clinical literature reviews to various clients that were accepted without revision by their respective Notified Bodies. In all cases, the products were approved for sale in the EU based in part upon the demonstrated safety and efficacy as shown by the analysis within the clinical literature review.
•Completed a meta-analysis on 17 indications for use of an intraaortic balloon pump. Indications included cardiogenic shock, septic shock, and myocardial contusions, to name a few. The report covered over twelve years worth of literature and included over 200 citations. A complete statistical analysis was performed on all of the data for each indication, as if all the citations for that indication had come from a single source, to determine the overall success rate of intraaortic balloon pump therapy for that indication. This report was highly praised by the client as excellent research and has been successfully used by them for FDA and EU audits as well as for marketing literature.
•Have prepared clinical literature reviews, conformity assessments, post-market analyses, and studies on safety and efficacy. Have written and published white papers on changing regulatory compliance guidelines for the EU and on how to prepare a meta-analysis. Co-hosted a regulatory compliance webinar with TUV, a Notified Body. Have presented multiple times at various medical device conferences on regulatory and reimbursement challenges for the medical device industry.
Samples of published work:
•Key Note Speaker. BIOMEDevice Forum 2009, December 9, 2009. Future Trends in Medical Devices.
•Invited Guest Speaker. OMTEC Orthopaedic Manufacturing & Technology Conference & Expo, June 24-25, 2009. Podium presentations on Domestic and International Medical Device Reimbursement and Regulatory Changes and Keeping Current with What is New.
•Co-Host of Webinar. Nerac Webinar Series, April 30, 2009. The Changing Directives in the European Union Medical Device Market: Are You Prepared for the March 2010 Deadline? With Jennifer Bromm, Medical Products Manager, TUV Notified Body.
•White Paper. The Power of Meta-Analysis | How Smart Companies Are Using A Statistical Methodology to Drive Breakthroughs. Nerac. December, 2008.
•White Paper. Clinical Literature Reviews | Changes in EU Medical Device Directive Require Immediate Steps. Nerac. December, 2008.
•Journal Article. MX Magazine Nov/Dec 2008. Bafan, M, J Prsha, and D. Schenberger. Convergence, Collaboration, Commercialization: Tomorrow’s healthcare marketplace will belong to companies that can collaborate effectively to produce next-generation combination products.
•Journal Article. MD&DI magazine. August 2008. Lloyd, Mayott, Schenberger, De Fazio, and Burke. Challenges to International Device Reimbursement: Manufacturers must prepare themselves with a thorough understanding of international nuances.
•Conference Presentation. ASME Frontiers in Biomedical Devices Conference presentation. June 18-20, 2008. Irvine, CA. Putting a Charge in Healing: Electrical Stimulators Show Great Promise, Especially for Spinal Fusion.
•Journal Article. MedTech Precision. http://www.devicelink.com/mtprecision/archive/08/04/008.html. April, 2008. Bafan, M. and Schenberger, D. Bioceramics: The Future of Joint Healing.
•Interview Citation. Consumers Digest. April, 2008. Owen, D. with cited information from Schenberger, D. Future Technologies in Joint Replacement.
•Conference Presentation. Institute of Biological Engineering Annual Meeting. March 6-9, 2008. Chapel Hill, NC. Mainstreaming MEMS: Microfluidic Drug Delivery Systems are Now a Market Reality, A Patent and Marketplace Review.
•Journal Article. MDT Medical Design Technology. Perspectives: Metal in Healthcare. www.mdtmag.com. 12:2 (Feb, 2008), p. 12.
•Short Online Article. Blind Faith: Advances in Artificial Corneas. Nerac Marketplace Review. www.nerac.com/medical-device/feb08_review/blind-faith. February, 2008.