Methodize takes great pride in bringing together the foremost experts in medical device consulting to form our global team of specialists. We’ll work with you and our team to ensure that your project gets all the advice, facilitation, and expertise required to meet and exceed your goals.
Heather is a consulting professional with 15+ years of experience in global project management, operations management, budget/grant/contract management ($25M+), change management, line management, strategic planning, training development, protocol development, phase II-IV pharmaceutical development, class II-III medical device development, audit preparation & execution, clinical trial regulatory compliance, ICH good clinical practice, and CAPA development and implementation. Heather is an expert at grasping complexities and absorbing large amounts of information to make big picture decisions that are aligned with standard operating procedures for project goal realization. Heather has worked with a broad array of companies including start-ups and global medical device and pharmaceutical companies. Very few people in the industry have the breadth and the depth of experience in clinical affairs that Heather has. Heather can help you create and execute strategic plans for the clinical affairs challenges you are experiencing and provide risk mitigation practices that will prevent future challenges.
Drawing on his strong knowledge of databases, software development, software validation, and software testing techniques, Robert has been successful in securing FDA, Canadian, and EU approval for medical devices in which device functionality requires custom software.
Robert holds Bachelor of Science degrees in Pharmacy and Microbiology from the University of Minnesota, and certifications as an ASQ Certified Software Quality Engineer (CSQE) and ISTQB Certified Software Tester (CTFL).
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.
Doug is a Microbiologist with over 30 years of experience in the medical device and biopharmaceutical industries. 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.
Linda (Linn) Laak 25+ years of professional experience in the Medical device field includes 17 years in Clinical and Regulatory Affairs. She is currently the President of the Fernbrook Group LLC a medical device clinical consulting group specializing in CER and medical writing for regulatory. Most recently she served as the Vice President of Clinical Research for Tryton Medical following 6 years as the Vice President of Regulatory, Clinical and QA for Atritech, Inc (WATCHMAN LAA closure device). She has held Executive positions for 2 CRO’s: PPD Medical Device following the sale of Eminent Research Systems and Clinsights Inc., where she was C.O.O and Vice President. Her experience includes positions of Vice President of Regulatory, Clinical and QA at XRT, C.L. MacIntosh & Ass., and Director of SCIMED’s Clinical Research Department. Linn worked in the marketing department as Group Product Manager of SCIMED’s Fixed Wire and Specialty Division. Prior to working at SCIMED, Ms. Laak also worked with Pharmacia Deltec and AVI/3M Healthcare in various sales, marketing and clinical training positions.
Her expertise in clinical studies, and regulatory and as well as her ability to successfully expedite the complicated process of getting product through clinical trials and to the market is some of her marked achievements in the Medical Device field.
Ms. Laak is also active in community volunteer activities with Residential Hospice, Catholic Women at Work, Leadership Development. As a cancer survivor, she is also a mentor (Firefly) to newly diagnosed breast cancer women across Minnesota.
Linda is an experienced Quality System Specialist in the medical device industry. She provides companies with expertise in developing, implementing, and maintaining quality assurance systems for a variety of devices and levels of company sophistication. Her experience allows her to support easier maintenance and greater compliance with regulatory requirements. Linda is a proven problem-solver who works collaboratively with management and cross-functional teams.
Hieu is a consulting professional with 25 years of medical device experience in strategic planning, product development pipeline, new product commercial releases, design control, and program management. Hieu has a proven track record of successful global commercial launches of class II and III products and sometimes multiple products at the same time. Hieu has worked in start-ups and global medical device and pharmaceutical companies. With Hieu’s unique broad spectrum experience, Hieu can help you generate a strategic plan, align it with the product development pipeline, and execute the projects to product commercial launches.
Matthew is an experienced Quality Systems Manager with over 18 years of expertise in Regulatory, Manufacturing, Design, and of course, Quality. Matt takes the time to focus on a company’s agreed upon goal and then takes the proper course of action to achieve the desired result. He believes in developing systems by integrating the regulatory requirements in the planning process, which in turn streamlines the work for your company.
As Managing Partner at Metaplan, Tom Knox is responsible for leading all development aspects of insight creation and strategy developments for Pharmaceutical, Biotech and Medical Device organizations. Tom’s long history of cross-functional leadership positions allows him to guide clients in their effort of balancing the complex interplay of Payers, Health Care Professionals and Patients. His in-depth knowledge of access and reimbursement will help organizations strengthen the organizational leadership role of Managed Care Functions beyond just being “account” and “contracting” experts. Utilizing Metaplan’s stakeholder orientation combined with his experience implementing several integration processes enables Tom to provide companies the ability to quickly re-gain maximum functionality.
Prior to joining Metaplan, Tom worked as Vice President, Managed Markets & Government Affairs for Allergan, Inc. During his 9+ years at Allergan, Tom was responsible for strategy and execution related to reimbursement and policy supporting business units in Ophthalmology, Neurology, Urology, Medical Dermatology, and Medical Aesthetics. Tom has experience in the development of strategy related to all aspects of Medicare, Medicaid, Commercial, Specialty Pharmacy and Policy.
Prior to Allergan, Tom helped to establish two new businesses, HealthNexis a company founded by Cardinal Health, McKesson and AmeriSourceBergen, and aaiPharma a specialty pharmaceutical company focused on pain management. For 15 years Tom worked at Novartis Nutrition in multiple roles related to Sales & Marketing, Account Management and Business Unit leadership.
Tom attended the University of Illinois-Chicago, Cardinal Stritch University and Executive Leadership courses at Harvard University
Todd has over 20 years experience in a combination of International Regulatory Affairs and Domestic Quality Engineering Management disciplines. Todd has the expertise and determination to partner with Medical Device Manufacturers to increase sales and revenue by opening up new international markets by successfully completing International Regulatory Affairs Projects for various European and non-European countries world-wide. International Regulatory projects that involve an expertise in working with Medical Device Directive (MDD) 93/42/ECC, EU Harmonized Standards, Essential Requirements, various Authorized Representatives and Notified Bodies, U.S. State Department, various Secretary of State Offices, Consulate Generals and Embassies, U.S. Department of Treasury, Office of Foreign Assets Control (OFAC), U.S. Export Administration and Bureau of Industry and Security (BIS), ISO 13483, FDA CFR 820 as well as a variety of other other CFRs, and many International Medical Device Regulations.
Marilyn has over 35 years of quality assurance experience in the medical device industry and additional expertise with the IVD Directive. She offers leadership and professional insight for companies during any point on their path to bringing their product to market. She has served as a Director of Quality Assurance at a vast array of medical device companies. Marilyn is a RABQSA Certified Lead Auditor with many more certifications and credentials under her belt.
Mark is motivated to improve health care through assisting life science companies find innovative solutions for speed to market, cost effective systems, and enhanced product quality. He enjoys working with the very intelligent, dedicated and compassionate teams in our industry.
Mark listens to understand your unique business needs, culture and goals. He believes in applying thoughtful risk / benefit analysis in helping you improve business decisions, quality system implementation and product development efficiency. His approach combines hands-on work, team collaboration and strategic vision.
Mark brings over 27 years of experience in bringing Class II and III medical devices from concept through commercialization. His background includes product development, clinical and regulatory affairs and business team leadership. He specializes in developing efficient market approval strategies and effective negotiations with regulators. He has worked with a variety of medical devices and business models including implantable, interventional cardiology, combination drug-device, disposable, and capital electromedical equipment in start-up and high growth settings.
Lora is a consulting professional with over 11 years of experience in process and product engineering, commercialization, project management, regulatory and operations/quality management. She has a proven track record of successful medical device product launches for cardiovascular, neurovascular, and orthopedic markets. Lora’s long list of skills includes CE Marking, FDA submissions, Quality Assurance Audits, Risk Management, and program management for product commercialization.
JR has more than 20 years experience in Quality Systems and Manufacturing Operations. She has experience with medical devices and pharmaceutical products offering clients a broad knowledge base when it comes to current Good Manufacturing and Laboratory Practices and quality system standards. Her background includes implementation of Quality Management Systems, development of Quality Documents, internal and supplier audits, nonconformance systems, and training. JR is a detail-oriented professional who believes in adding value to whatever project she is given.
John has over 24 years of manufacturing experience with eleven of those years in the medical device industry. Not only has John worked as a Quality Assurance Engineer for medical device organizations, but he has also been trained to audit companies based on a number of ISO/ANSI/AAMI/EN standards. Because of his extensive knowledge in this area, John was recruited as a Medical Audit Team Leader and he provides training seminars to companies and individuals.
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.