Our team.
Jack Slovick - President and Chief Consultant
Jack has worked in the medical device and diagnostics industry since 1981. Throughout his career, he has gained a variety of experiences in regulatory, quality, and clinical services.
In 2004, Jack founded the consulting business, Methodize Incorporated. He wanted to offer results-oriented, strategic skills to a broader range of companies in need of approval for their medical devices and in-vitro diagnostics products. Jack seeks to build relationships with his clients by offering a personal approach to the consulting process. He chooses team members that, like him, seek out challenges, growth, creativity and opportunity with each project they take on.
Sheena Bond - Medical Device Auditor
Sheena Bond is a scientist working as a Medical Device Auditor and previously the Certification Project Manager. She gained expertise in CE marking (European Directives), Canadian Medical Device Regulation and MDSAP (Medical Device Single Audit Program) working with both the French and German Certification Bodies. Sheena is a Certified Lead Auditor, and a Design Dossier Reviewer for high-risk In Vitro Diagnostic devices. Sheena has also worked in industry with leaders in the medical device and diagnostics arena. With more than 20 years of experience in the medical device industry, Sheena utilizes her technical and regulatory expertise to assist medical device manufacturers in implementing regulatory requirements and ensuring their Quality Management System ( QMS) compliance.
Alan VanHouten - Senior Project Engineer
Alan is an experienced Senior Project Engineer with expertise in all areas related to bringing new single-use medical devices to market and into high volume production. Beyond the broad view of project management, Alan can assist with the details such as identifying specifications of mechanical components, analysis of technical drawings, and development of a system interface that conforms to standards, customer requirements, and system architecture requirements.
Tambra Dahlheimer - Healthcare Consultant
Tambra is a nurse practitioner caring for children with cancer in a pediatric Hematology Oncology clinic in a Midwest metropolitan academic and research center. Over 30 years of working in the pediatric oncology field gives her a unique expertise. A focus on neuro-oncology patients over the last 13 years makes her uniquely qualified to be a co-investigator for studies focusing on this population. It positions Tambra to participate in research aimed at understanding symptoms in these patients throughout treatment and at the end of life. Tambra has completed her doctoral coursework and practicum in doctoral level statistics, theory, research (quantitative and qualitative methods), research and healthcare ethics, research dissemination, grant writing and health care policy. She has also completed additional training on palliative care through Pediatric Nursing Certification Board (PNCB) in 2013 and the End-of-Life Nursing Education Consortium (ELNEC) training offered at the University of MN in 2014.
Emily Davis - Regulatory Affairs Specialist
Emily is a result’s oriented team leader with comprehensive regulatory affairs and quality management system experience. She resides in San Diego, CA and started out in the medical device industry in the IVD (in vitro diagnostic) world at a company who invented the world's first FDA Cleared and CE marked Bluetooth-enabled blood glucose meter. She started her own quality and regulatory consulting company with that experience and has since worked with many different companies where she has led different efforts such as development and execution of many 510(k) clearances; Regulatory Strategy consulting; Technical Documentation and Design history file creation, revision and maintenance; creation of medical device labeling; led many regulatory audits; created Software Design and Development documentation; creation of Risk Management documentation; assisted companies with Laser Annual Report submissions; assisted multiple companies with completing IEC 60601-1 electrical safety testing; etc. Most recently she started working at Medtronic as a Principal Regulatory Affairs Specialist but continues to help companies when time allows through her consulting business.
Emily graduated from Azusa Pacific University with a degree in Business Administration. She is a crossfit competitor, marathon finisher and enjoys all types of challenges within and outside of her profession.
Doug Harbrecht - Microbiologist
Doug is a Microbiologist with over 30 years of experience in the medical device and biopharmaceutical industries. He has been an independent consultant since 2012. Prior to that he worked for 20 years at Boston Scientific as manager of microbiology, sterilization and biocompatibility, and later as a Fellow in the corporate sterilization group. He has extensive experience in ethylene oxide, radiation (gamma and e-beam), and liquid chemical sterilization validation, reprocessing of devices, microbiology laboratory testing and management, controlled environment monitoring, biocompatibility, audit of contract laboratories and sterilization facilities, and support of regulatory submissions. He is also an active member on several AAMI sterilization standards committees and the ASTM radiation processing committee.