Information on the Speakers for HcPIE.
Randolph F.R. Rasch, PhD, RN, FAANP
Dr. Randolph Rasch is Dean and Professor of the Michigan State University College of Nursing. He has been the Director/Coordinator of two well-known family nurse practitioner (FNP) programs. Dr. Rasch has over twenty-five years of experience teaching in BSN, MSN, DNP and PhD programs in nursing. He has published and presented in the areas of primary care, HIV risk reduction, and diversity in health care education and clinical practice. Prior to his appointment as Dean, Dr. Rasch served as Chair of the Department of Community Practice Nursing in the School of Nursing at The University of North Carolina at Greensboro, and as the Director of two well known family nurse practitioner programs in the Vanderbilt University School of Nursing and the School of Nursing at the University of North Carolina at Chapel Hill.
Dr. Rasch was the first State-wide Director of Nursing Services/Programs Director in the Tennessee Department of Correction (TDOC), where he provided leadership and direction for nursing services, and assisted the Director of Health Services with the overall development, management, and operation of Health Services in the TDOC. As part of a three-member management team, Dr. Rasch was responsible for designing and implementing a system of health care for the TDOC, and as Programs Director, leading the development and facilitating the implementation of the Quality Assurance Program for Health Services in the TDOC. Dr. Rasch has consulted on a multitude of projects including analysis of nursing productivity and workload, and process improvement. Notably, his expertise is in the area of primary care and community health, particularly the roles, functions and appropriate skill mix for all levels of nursing; licensed practical nurses, registered nurses, advanced practice nurses/nurse practitioners, and cultural diversity in healthcare services. Dr. Rasch’s clinical experiences as a registered nurse include charge nurse on a surgical unit in a community hospital and public health nurse (PHN) and PHN Team Leader and home health nurse health care center; and a nurse managed clinic recognized as a clinical agency by the NC Board of
A Fellow in the American Association of Nurse Practitioners (FAANP) and a Distinguished Scholar and Fellow in the National Academies of Practice (DS&FNAP), Dr. Rasch holds the distinction of being the first African American male graduate of the nursing program at Andrews University, and the first African American male Masters-prepared FNP (a graduate of the FNP program at Vanderbilt School of Nursing). He is the first African American male to hold a PhD in nursing, and was the first African American male public health nurse in the State of Michigan.
Daphne Allen is Executive Editor of Pharmaceutical & Medical Packaging News, now serving as the pharmaceutical and medical device channel of PackagingDigest.com Daphne has covered pharmaceutical and medical device packaging, labeling, and manufacturing issues for more than 20 years. Follow her on Twitter at @daphneallen.
Dr. Bix is a professor at the School of Packaging at Michigan State University and an adjunct associate at Clemson University. She was appointed, and currently serves as the US delegate to ISO TC122 WG 9, a group which is developing a standard for measuring the accessibility of packages. Bix served as the Vice-Chair of Committee D10.32, the Committee on Consumer, Pharmaceutical and Medical Packaging, from 2004-2007, and as a member of Committee F-02, the flexible barrier material committee, since 2002. In 2008 she was named one of the 100 most notable people in the medical device industry by Medical Devices and Diagnostics Industry.
PKG 452 Medical Packaging: Special requirements for packaging pharmaceuticals and medical devices. Evaluation of package systems and packaging procedures.
PKG 485 Packaging Development: Package development including selection, design and implementation of package systems for protection, distribution, merchandising, use and disposal.
PKG 490, Section 003 Directed Studies in Packaging: Development of solutions to specific packaging problems. Supervised individual study.
Commander Mary Elizabeth Brooks
Commander Mary Brooks works at the FDA as the Senior Lead Reviewer for medical devices in General Hospital Branch for the Office of Device Evaluation within the Center Devices Radiological Health. She holds a Bachelor’s degree in Nursing and a Master’s degree in Business Science- Quality Systems Management. She has been involved in numerous Center level projects to include a two year rotation to Office of Surveillance and Biometrics as a post-market analyst evaluating medical device failures and adverse events. Her love for medical devices came naturally when at the age of 5 her mother was diagnosed with acute renal failure and brought home a peritoneal dialysis machine. Prior to coming to FDA, she worked in various areas of healthcare as a nurse to include home health, infusion therapy, emergency, oncology, and case management.
Commander Brooks is an active duty nurse with the United States Public Health Service and been deployed numerous times providing care to underserved populations in disasters and health crises. Her most recent deployment was Liberia, Africa where she worked at Bong’s Ebola Treatment Unit (ETU) and United States Public Health’s Monrovia Medical Unit (MMU) where she provided direct patient care to Ebola patients. She is a recent recipient of the Presidential Unit Citation for her efforts in Liberia.
She lives in Northern Virginia with husband. When she’s not deployed or stuck in DC traffic, she enjoys general aviation flying, cycling, cooking and gardening.
Ms. Crisp is a Health Care Professional and American Heart Association Instructor at the Michigan State University Learning and Assessment Center (LAC). She has worked at the center since 2013. Ms. Crisp has been a Registered Nurse for over 20 years, with clinical experience in Trauma Center, Emergency Department, Cardiology/Cardiovascular Surgery, and Primary Care.
In addition to her position at the LAC, Ms. Crisp is an Instructor in the Michigan State University College of Nursing. She earned her Master’s Degree in Nursing from Michigan State University, is a Certified Emergency Nurse, and a Trauma Certified Registered Nurse.
20 years employed full time in Emergency Medicals Service and 12 years as a Firefighter Paramedic, Technical Rescue Specialist, HazMat Specialist in transport (rail and ground), and CBRN HazMat Technician. Critical Care Transport Technician, Michigan Firefighters Training Council Fire Instructor, State of Michigan Paramedic Instructor Coordinator, American Heart Association BLS, ACLS, and PALS instructor, per diem faculty Michigan State University College of Osteopathic Medicine, Learning Assessment Center.
Dhuanne Dodrill is the President of Rollprint Packaging Products, a flexible packaging converter specializing in technically innovative products for the healthcare, food, and, industrial markets. With over 25 years of experience in the flexible packaging industry, Dhuanne has worked in a variety of technical, quality assurance, and management positions. She is the chair of ASTM’s Committee F02 on Flexible Barrier Packaging, serves on the Board of Directors of the Flexible Packaging Association, is on the Executive Committee of the Sterilization Packaging Manufacturers Council, is active with IoPP’s Medical Packaging Task Group and AAMI Technical Committee 198, Sterilization, Working Group 7, and serves on the Executive Committee of the Board of Directors of Summit Insurance. Dhuanne has a B.S. in Chemical Engineering (with honors) from the University of Illinois Urbana-Champaign.
Nick Heslip is a Principal Project Engineer in Medtronic’s Cardio-Vascular Packaging and Labeling organization. His group works to advance the use of new or novel designs, materials and processes enhancing sterile barrier protection, user functionality, and pack-out and logistics efficiencies. He has 10 years of experience working in various roles including Packaging Engineer, Manufacturing Engineer, Manufacturing Group Leader and currently Project Engineer. Nick has held these roles in various industries such as dental supplies/devices, pharmaceuticals and medical devices (cardiovascular and orthopedic). He holds a BS in Packaging from Michigan State University and a MBA from Ball State’s Miller College of Business.
Shannon Hoste is a Human Factors Engineer in the Human Factors Pre-Market Evaluation Team of FDA’s Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE), where she reviews Human Factors data for ODE, OIR and pre-market submissions which cross centers. Prior to joining the FDA in January 2015, Shannon spent 18 years in the medical device industry as a Human Factors/ System Engineer and R&D manager. Over this time she has worked within and directed project teams in all phases of product development from front end research to post-market support. Over her industry career, she had been integrally involved in bringing a wide range of product types to market including devices for home health, telemedicine, surgical applications, laboratory applications, respiratory care, diabetes care and assistive technologies. Shannon has a BS in Mechanical Engineering, MS in Cognitive Systems Engineering and MS in Management.
Education: B.S. in Packaging from Michigan State University. Activities: ISTA Global Board of Directors and Past Chair, ASTM D10, US Random Vibration Expert for ISO-TC122-SC3-WG7, Editor International Journal of Advanced Packaging Technology (IJAPT), International Association of Packaging Research Institutes (IAPRI). Achievements: ISTA CPLP Professional, numerous technical presentations, publications and training sessions, Transportation packaging expert witness.
Linda Keilman, DNP, GNP-BC
Dr. Linda Keilman has been a nationally certified Gerontological Nurse Practitioner since 1989 and teaching nursing since 1983. She has been a faculty member in the College of Nursing at MSU since 1992. Before entering the nursing profession, Dr. Keilman was an elementary school teacher. Dr. Keilman has worked as a nurse practitioner in a variety of settings; her current MSU Health Team practice is providing primary care for residents in long-term care. Function and quality of life are important components of her clinical practice. Dr. Keilman also consults with the Care Management Resource Center at the University of Michigan on a Blue Cross Blue Shield demonstration project for helping to keep frail older adults with co-morbid conditions living in their homes with the help of care management.
Dr. Keilman was the curriculum and content expert with the federally funded Geriatric Education Center of Michigan from 1995 - 2015, educating health care professionals in the state of Michigan on how to appropriately care for older adults. Dr. Keilman is working with the College of Osteopathic Medicine at MSU - developing a combination Family Practice/Internal Medicine Geriatric Fellowship curriculum. The curriculum is based on optimal aging from a holistic, person-centered approach and if federally funded. Additionally, Dr. Keilman and two colleagues from MSU Communication Arts & Sciences received funding from the Michigan Humanities Council for their project, The Living History Project: Stories Told by Michigan’s Oldest Old. Individuals 85 and older were interviewed and filmed, creating a documentary that was recently nominated for a Michigan Emmy. The team received a national Creative Works Showcase Award in August 2015. Dr. Keilman is a frequently invited speaker to national conferences and serves on several national aging boards and committees.
Rod Kinghorn retired in June 2012 as General Director of Global Security at General Motors where he was responsible for GM’s Global Security Operations. Mr. Kinghorn graduated from Michigan State University School of Criminal Justice in 1974 with a Bachelor of Science degree. Upon graduation, he worked with General Motors Security from 1974 until his retirement in a variety of positions. In addition to security-related functions, he also held positions where he was responsible for fire protection and prevention, plant safety and worker’s compensation, employee business travel and company vehicle operations. A majority of his assignments since 1984 for GM were in the field of investigations where he used an integrated business process to direct investigations that included: internal and external frauds, thefts, major policy violations, allegations of criminal activity, loss of proprietary information, forensic analysis of information systems, counterfeit automotive parts, health care fraud, workplace violence threats, and undercover drug operations in support of GM’s Global Operations. During his career Mr. Kinghorn’s participation in related professional organizations has included serving 10 years on the Nevada Safety Council Board of Directors, with seven years as the Vice President of Administration, Chairman of the Sierra Nevada Chapter of the American Society for Industrial Security (ASIS), advisor, Secretary, President and Chairman for the Michigan Chapter of Infragard, and Chairman for the Michigan State University Identity Theft business partnership. In 2004, Mr. Kinghorn was honored as a recipient of one of the first Alumni service awards presented by the MSU School of Criminal Justice during a ceremony held in East Lansing, Michigan. Additionally, Mr. Kinghorn was an inaugural member of the A-CAPP Industry Advisory Board. Currently, he serves as an Outreach Specialist for the A-CAPP Center.
Jiyon Lee is a Ph.D student working with Dr. Laura Bix’s team. While she was attending Yonsei University in Korea, she had several internship and research assistance experiences in packaging field. She earned her master degree in packaging from Michigan State University in 2013. After her master, she worked for food company, CJ Cheil Jedang in Korea, as a packaging engineer. She has pursued her ph.D since 2015. Her main focus on her ph.D works is to investigate on healthcare provider’s aseptic opening behavior in healthcare context. Her hypothesis is that people exhibit different behavior and use different coping strategies on opening packages when they have physical or(and) psychological constraints(chaos).
Debra Lindstrom, PhD, OTRL, FAOTA has been an occupational therapist for over 30 years and is a Professor in the Department of Occupational Therapy at Western Michigan University. She earned a Masters of Occupational Therapy and a Doctorate of Philosophy in Sociology from Western Michigan University. She was recently awarded a Fellow of the American Occupational Therapy Association. She started the “Twinges in the Hinges” water exercise class for arthritis at the Kalamazoo Family YMCA in 1981 and has presented multiple programs throughout the area on how to minimize pain and protect joints while carrying out activities of daily living. . She is a Founding Fellow for the WMU Center for Gerontology. She has worked closely with AARP MI since 2005 and was the Executive Volunteer for Livable Communities from 2005-2012, and an Advisor to the Executive Council from 2012-2014She is the co-creator of the AARP program HomeFit that has been provided in Michigan since 2009 and has been adopted by 25 other AARP State offices and is gaining in popularity throughout the rest of the United States. She is a recent co-author of the chapter Assistive Technology and Older Adults in a 2015 textbook on OT with Aging Adults. She has an extensive list of journal publications, and has published on grip/pinch strength testing and hand manipulation assessment psychometrics and norms. She is currently involved with a project to examine the ecological validity of a multiple setting pinch meter to determine the pinch strength needed to open different packages. She completed a collaborative project with Dr. Laura Bix, MSU School of Packaging, to determine grip strength older adults needed to open different types of medication packages.
Mrs. Loomis serves as a Simulation Educator at the MSU Learning and Assessment Center. She is responsible for the development, planning, and implementation of simulation events in the center including standardized patient encounters, immersive clinical simulation, off-site in situ simulation, and BLS courses. She began working in the center in 2015 and has been a nurse for 8 years with clinical expertise in Medical-Surgical nursing. Previously, she worked as a teaching clinician and clinical instructor in nursing education. She completed her BSN from Saginaw Valley State University and her Master’s degree in Nursing Education from Ferris State University.
Paul Marshall has over 20 years of experience within the packaging industry that covers a variety of different industries such as military/defense, retail, industrial, pharmaceuticals, and medical device packaging applications. The majority of his career has focused within the medical and pharmaceutical packaging sectors. Over his career, Paul has earned several awards for excellence in packaging development, including three Ameristar Awards, one Worldstar Award, and one US/International patent. Paul is a Certified Packaging Professional with Lifetime status (CPPL) and Project Management Professional (PMP). He has been employed with Smith&Nephew for the last four years as the Manager of Global Packaging Technologies. In his role, Paul is responsible for ensuring global compliance to global regulatory bodies packaging requirements. He also manages the Memphis Packaging Lab and supports testing for all sites globally. In addition, Paul manages both the Packaging Process Engineering and Packaging Sustaining Engineering teams across the US. In the past several years, Paul’s team has been responsible for developing sustainable packaging solutions that support Smith&Nephew’s business goals of improving the company’s position on the Dow Jones Sustainability Index (DJSI) and showcasing and communicating those successes as it relates to improved sustainability metrics.
Dr. Kelly F. Millenbah is the associate dean and director for academic and student affairs in the College of Agriculture and Natural Resources at Michigan State University (MSU). In that role, she oversees the academic portfolio of the college (including two-year certificate, undergraduate and graduate programs encompassing approximately 4,800 students) and manages the college’s General Fund account. She is also a professor in the Department of Fisheries and Wildlife.
Millenbah is a scholar of natural resources education with a focus on teaching and learning within the classroom, curricular design and development, and recruitment and retention of students in the sciences. She earned her B.A. degree in Biology from Ripon College, Ripon, Wisconsin, and her M.S. and Ph.D. in Fisheries and Wildlife at MSU.
She has been recognized for her commitment to teaching and learning through several awards including a Lilly Teaching Fellowship, the MSU Alumni Club of Mid-Michigan Quality in Undergraduate Teaching Award, the Sigma Alpha Agriculture Advocate Award, and the MSU College of Agriculture and Natural Resources Distinguished Faculty Award.
Millenbah previously served as the associate director of the Environmental Science and Policy Program, director of academic programs in the Department of Fisheries and Wildlife, and associate dean of Lyman Briggs College (a residential college for students interested in the sciences), all at MSU.
Dan Penny is the Director of Packaging Engineering for Cardinal Health where he has worked since 2001. His team is responsible for package design and process development as well as continuing engineering for Cardinal Health’s medical device packaging. In total he has more than 30 years of experience in the medical device industry. Dan spent his first 16 years working for a converter of medical device packaging materials. There he led process engineering and product development teams working on blown films, laminates, pouches, and bags. He holds a BS in Packaging from Michigan State University and an MBA from Keller Graduate School.
Paula Perez is a PhD candidate in the School of Packaging. Her research is focused on leveraging new flexible package designs and a modified aseptic technique to reduce contamination in sterile devices during aseptic presentation. Paula previously worked as a Project Engineer at Edwards Lifesciences in the Dominican Republic, and completed internships with Unilever and A&Z Pharmaceuticals. She holds an MS in Packaging from Rochester Institute of Technology, as well as dual BS degrees from State University of New York at Farmingdale in Manufacturing Engineering Technology and Facility Management Technology/Industrial Technology.
Francie Pouch Downes
Dr. Downes is currently a professor at Michigan State University in East Lansing Michigan with a joint appointment in Biomedical Laboratory Diagnostics and Public Health Programs. Prior to joining MSU, for 12 years she was State Public Health Laboratory Director and Administrator of the Bureau of Laboratories at the Michigan Department of Community Health. She has over 22 years of experience in public health laboratories.
Dr. Downes was President of the Association of Public Health Laboratories from 2008-2009 and served on the Board of Directors from 2004-2012. She served on federal advisory committees addressing microbiological safety of food and tuberculosis control. She was appointed to the Centers for Disease Control and Prevention’s Scientific Advisory Committee. She is also a member of the American Society for Microbiology and other state and local professional organizations.
Her interest in global health stems from her Peace Corps Volunteer work in Zinder, Niger in West Africa. She continues this passion through providing laboratory quality and technical assistance in Mozambique and China. She also worked in Burundi, Jamaica, and Botswana. She provided program development input to the World Health Organization on network development and tuberculosis testing.
A graduate of the University of North Carolina Chapel Hill (Dr.P.H. and MPH) and Indiana University (BS), she is also a certified medical laboratory scientist (ASCP) and high complexity laboratory director (ABB).
Dr. Maria Rubino is an Associate Professor in the School of Packaging and has been at Michigan State University since 2004. Maria also has over 15 years of industrial experience working as a scientist in chemical and food companies. Her research is focused on the mass transfer of vapors, gases and additives in polymer materials and packaging systems, and on developing packaging strategies that will contribute to the overall safety of foods and pharmaceutical products. She teaches courses on packaging permeability and shelf life and the application of instrumental analysis for packaging.
PKG 490, Section 010 Directed Studies in Packaging: Development of solutions to specific packaging problems. Supervised individual study.
PKG 817 Instrument Any Packaging Matl: Analytical methods for packaging including spectrophotometry and chromatography. Material identification and characterization. Migration and permeation measurements.
PKG 815 Permeability and Shelf Life: Relationship between the storage life of packaged food and pharmaceutical products and the gas, moisture, and organic vapor permeability of packages in various environments.
Erin Sarzynski, MD, MS, earned an undergraduate degree in biochemistry from Michigan State University and a Master of Science degree in entomology from the University of Florida. She received her medical degree from MSU College of Human Medicine and completed a residency in internal medicine at MSU, graduating in 2010. She completed the Sparrow/MSU Geriatric Fellowship in 2011 and has a Certificate of Added Qualification in Geriatric Medicine. Presently, Dr. Sarzynski is an Assistant Professor in the MSU Department of Family Medicine, Geriatrics Division. She has a dual position in the Institute for Health Policy at MSU. Dr. Sarzynski practices as an internist and geriatrician, and her research interests include medication management, health literacy, health information technology, and transitional care.
Tony Trier (B.S., 2009; M.S., 2012) is a PhD candidate working with Dr. Laura Bix’s HUB team. Tony is currently a Packaging Engineer working for Cardinal Health at the Packaging Technology Center in Waukegan. In graduate school, Tony worked on human factors packaging projects with the industry in addition to his own research. His focus has been on understanding how sterile products may become contaminated during aseptic presentation of items to the sterile field. In order to explore this idea, he has leveraged multiple academic disciplines and methodologies to better understand aseptic technique, and what it means to the packaging industry.
Pan Wu is a PhD candidate in Engineering Mechanics with a research oriented towards human body Biomechanics. Her dissertation focuses on venous ulcers on lower legs, by applying engineering knowledge and techniques, to better understand the ulcer formation and ulcer risk assessment. She also worked on projects including the study of human body movement and soft tissue deformation. She is currently working with Dr.Bix and Paula on the BCBS package design project.