March 2010 ContributorsMarch 2010 Contributors
March 25, 2010
Michael N. Abrams is coauthor of the "The Need for Compliance as a Business Strategy." He is managing partner of Numerof & Associates (St. Louis, MO). He has worked extensively in the areas of strategic planning and implementation; product strategy and portfolio development; market analysis; and operational improvement across the entire healthcare spectrum. Contact him at [email protected].
Nancy Cafmeyer is coauthor of "Buyer Beware: A Quest for Vendor Qualification." She is project manager at Advanced Biomedical Consulting LLC (St. Petersburg, FL). She has consulted pharmaceutical, nutritional supplement, and medical device manufacturers. Previously, she held management positions at King Pharmaceuticals. Reach her at [email protected].
Bridget Foltz is coauthor of "Mastering the Clinical Investigation." She is a policy analyst in the Office of Good Clinical Practice (GCP), a focal point within FDA (Silver Spring, MD) for GCP and human subject protection issues arising in human research trials regulated by the agency. At the time of the article, Foltz was a consumer safety officer at CDRH. She has an MS in biotechnology from Johns Hopkins University. Reach her at [email protected].
Jonathan Helfgott is coauthor of "Mastering the Clinical Investigation." He is a consumer safety officer for FDA in CDRH within the Division of Bioresearch Monitoring (BIMO). He specializes in computerized systems used in clinical investigations for CDRH BIMO. Helfgott is coeditor of the FDLI’s 2009 publication, Biomedical Software Regulation. Reach him at [email protected].
Sue Hocker is coauthor of "Mastering the Clinical Investigation." She is principal for The Lindyn Group (Baltimore). She provides consulting and freelance services in strategic marketing, market research, and medical writing. She designs and fields recruitment programs for clinical trials and works with clinical teams to identify the causes of slow enrollment. Reach her via e-mail at [email protected].
Doug Jennings is coauthor of "Overcoming Concerns about Outsourcing to Asia." He is a mechanical design engineer for PA Consulting Group (Cambridge, UK, and London). He specializes in product development of pharmaceutical and drug-delivery devices. He is also responsible for maintaining the company’s ProEngineer, SolidWorks, and Inventor workstations as well as recommending new software improvements. Contact him at [email protected].
Dennis Johnson is author of "Mass Customization in Medical Connector Design." He is president and CEO of Onanon Inc. (Milpitas,CA), a connector manufacturing company. He is an expert in the design and manufacture of electromechanical interconnects for the medical device industry and is active in transforming the way they are manufactured. Reach him at [email protected].
David Kalish, Esq., is author of "Best Practices: Designers and Patent Attorneys Unite." He is a member of Coats and Bennett PLLC (Cary, NC). He offers his clients extensive experience in various aspects of patent preparation and prosecution, as well as management of patent-related matters and noninfringement, invalidity, and clearance opinions. Contact him at [email protected].
Jonathan M. Lewis is coauthor of "Buyer Beware: A Quest for Vendor Qualification." He is a principal at Advanced Biomedical Consulting LLC, has consulted more than 50 different biopharmaceutical, pharmaceutical, and medical device manufacturers. Previously, Lewis held positions at companies such as Cardinal Health, KMI, and Parexel International. Contact him at [email protected].
Marci Macpherson is a senior quality assurance auditor with Abraxis BioScience (Marina Del Rey, CA). Her certifications include ASQ CQA and RQAP-GCP. She has worked for biotechnology firms and contract research organizations. She contributed to the article as a CDRH BIMO intern. Reach her at [email protected].
Michael Marshall is president of Kloehn Inc. (Las Vegas) and the global life sciences sector leader of its parent company, Norgren Inc. (Littleton, CO). During his more than 21 years with Kloehn, Marshall has focused on engineering and the commercial side of business. Reach him at [email protected].
Rita Numerof, PhD, is coauthor of the "The Need for Compliance as a Business Strategy." She is president of Numerof & Associates Inc. An internationally known consultant, the focus of her work addresses the challenges of maintaining competitive advantage in highly dynamic and regulated markets such as medical devices. She also serves as an advisor to Congress on healthcare reform and comparative effectiveness.Contact her at [email protected].
Russ Nyberg is author of "To Assess or Determine? Unraveling the D-Value." He is director of retail sales and tech support and a biological indicator specialist for Raven Labs (Omaha, NE), a division of Mesa Labs. His area of expertise is the use of biological indicators for sterilization processes in the pharmaceutical industry. Contact him at [email protected].
Pradnya Parulekar is author of "Consistency is King in Silicone Molding." She is custom manufacturing services brand market manager for Helix Medical LLC (Carpinteria, CA), focusing on medical devices, components, and subassemblies. Prior to joining the company, she was an account manager for Helix’s parent company, Freudenberg-NOK General Partnership. Reach her at [email protected].
Chuck Philipp is vice president, business development, at Value Plastics Inc. (Fort Collins, CO), an injection molder of precision connectors for the healthcare industry. He has more than 20 years of experience in the medical device and biotech industry. He has a BS degree in engineering from Texas A&M University. Contact him at [email protected].
Riley Phipps is the technical and design services manager at Value Plastics Inc. Riley has more than 10 years of experience in injection molding and working with medical device and biotech companies to define cost-effective connector solutions. Contact him at [email protected].
Stephen E. Rothenberg, JD, is coauthor of the "The Need for Compliance as a Business Strategy." He is a business analyst for Numerof & Associates Inc. Rothenberg has supported compliance functions in auditing and monitoring, risk assessment, and development, as well as implementation of fair market value determination processes in the pharmaceutical and medical device industries. Contact him at [email protected].
Nancy Singer is coauthor of "Mastering the Clinical Investigation." She is president of Compliance-Alliance LLC (Arlington, VA), a firm that serves designers, manufacturers, and regulators of medical devices. She was formerly special counsel at the Health Industry Manufacturers Association (now AdvaMed). Reach her at [email protected]. Robin Strongin is author of "First Person: Health Reform in 140 Characters." He is president and CEO of Amplify Public Affairs LLC (Washington, DC). Her areas of specialization include healthcare, science, technology, and innovation. She is currently serving on AcademyHealth’s Translation and Communications Interest Group. Previously, Strongin served as a senior research associate with the National Health Policy Forum at George Washington University. Reach her at [email protected].
Steve Szabo is business development manager for Kloehn Inc. He is responsible for developing the company’s business in the area of precision fluidic components, which includes syringes, solenoid and shear valves, pumps, needles, probes, and accessories. Contact him at [email protected]. Tom Walczak is author of "Better by Design: Seeing a Contract Molder's Support Up Front." He is genera
l manager of Dicten Masch Plastics’ thermoplastics plant (Nashotah, WI). He is an award-winning engineer who has received 13 U.S. patents over the course of his career. As an advocate of virtual builds, Walczak guides the Dickten Masch engineering team to identify part design issues, interferences and assembly issues before producing a single part in order to reduce client costs and increase speed to market. He can be reached at [email protected]. David Whitaker is coauthor of "Overcoming Concerns about Outsourcing to Asia." He is a principal consultant for PA Consulting Group. He specializes in the design and industrialization of medical devices and has expertise with inhalers, diagnostic devices, transdermal delivery systems, neonatal breathing support apparatus, tools for invasive surgery, and interventional cardiology. Contact him at [email protected].
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