TODD DAWSON, JD
Todd has practiced as a registered patent attorney for 30 years and has over 25 years of experience in the orthopedic industry specializing in Intellectual Property matters. He began his career in orthopedics in 1991 as a patent attorney in the Zimmer legal department and held executive-level legal positions including Vice President, Global Intellectual Property Counsel. After leaving Zimmer he served as the Vice President and Chief Compliance Office for Olympus Corporation of the Americas where he established the compliance department and culture for the company. Utilizing his broad legal background, Todd founded Dawson Consulting, LLC in 2011 to provide legal services specializing in intellectual property, licensing, and healthcare compliance issues to start-up companies in the medical device field. Todd moved to Colorado to assist one such start-up as the Vice President Intellectual Property and was instrumental in the eventual purchase and transition of that company to Biomet. Biomet convinced Todd to return to Warsaw and assume the position of Vice President and Associate General Counsel, Intellectual Property in their legal department where he led the department and assisted in the purchase and transition of Biomet by Zimmer. During his career Todd has led a number of cross-functional multi-national teams in the development of company programs in addition to his leadership of Intellectual Property Departments. Todd’s expertise spans adult reconstructive, trauma, spine, sports medicine, extremities, endoscopic, and biologics fields. His passion for orthopedics and intellectual property is only surpassed by his love for the World Champion Chicago Cubs.
Todd holds a Juris Doctor degree from Valparaiso University School of Law and a B.S. in Electrical Technology from Purdue University. He is a registered US Patent Attorney and is licensed to practice law by the State of Indiana.
Mark has over 20 years of experience working in reimbursement, health policy and health economics for various organizations including orthopedic and cardiovascular medical device companies, providers and health systems. He is currently the founder and president of an independent consulting firm focused on strategic reimbursement and health economics consulting for medical technology companies. He works primarily with early stage companies to develop and execute their reimbursement strategies and develop health economic messaging for successful product commercialization.
Mark has a track record of success, including acquiring incremental hospital payment from CMS, including New Technology Add-On Payments, APC Pass-Through and New Technology APCs. He has also secured new coding for multiple technologies, and engaged various payers, including national and local Medicare to achieve positive coverage.
Prior to forming his consulting practice, Mark has developed and led the health economics and reimbursement function in multiple companies. He was most recently Senior Director, Global Healthcare Economics for St. Jude Medical, focusing on global integration of the function across the entire product portfolio, and developing relationships with payers, including Medicare. Mark has served in similar leadership roles in various other medical device companies, including Zimmer, CardioMEMS, Restore Medical and Medtronic.
Prior to these roles, Mark spent 10 years in health care consulting, assisting payers, providers, pharmaceutical and medical device companies on various strategic initiatives and projects. He has a Master of Business Administration degree with a focus on Healthcare Administration from the Wharton School, University of Pennsylvania and a Bachelor of Science in Accounting from Minnesota State University, Moorhead.
MIKE HAWKINS, PhD
A 35-year veteran of the orthopedics industry, Mike retired in 2015 from Zimmer Holdings as the Vice President of Corporate Research. Prior to serving in that role, he held various executive-level positions in the Research, Marketing, Manufacturing and Quality areas where his problem-solving mindset led to significant value creation for the company in terms of new product development and efficient, high quality production processes. Mike has worked across a multitude of orthopedic fields including adult reconstructive, trauma, spine, sports medicine, extremities, and biologics.
Mike holds a Ph.D. in Mechanical Engineering from the University of Notre Dame, where he also completed his Master’s in Mechanical Engineering. He also holds a Master of Science in Chemistry from Eastern Illinois University and a B.A. in Mathematics and Chemistry from University of Indianapolis. Mike is also certified by the US Patent and Trademark Office to practice patent law and holds 20+ US patents.
Kris has been providing federal grant proposal support services and project management to clients for over 17 years through her independent consulting firm. She specializes in SBIR/STTR preparations and submissions and has worked on over 250 proposals just in the last 10 years. Her proposals have been submitted to all 11 participating federal agencies, for both contract and grant solicitations, Omnibus and special solicitations, SBIR and STTR programs, and Phase I, Phase II and additional Phase programs (FastTrack, Phase IIB, etc.). Kris has prepared and managed large, multi-site clinical trial applications and has extensive knowledge of required registration and submission sites, ensuring complete and correct submissions. She has enjoyed extensive work with two major research universities (Indiana University and Purdue University), supporting over 65 submissions since 2010. By reading an average of 25 summary statements per year, Kris has developed an acute awareness of trends and themes among granting agencies and review panels, which helps in guiding her clients to the most appropriate grant opportunities. Her depth of experience in the grant writing field has allowed her to create a highly refined process that provides maximum efficiency and results in quality and competitive proposals. The things that Kris enjoys most about her work are the direct interactions with clients and a hands-on role on projects.
Kris is a proud graduate of Indiana University’s School of Public and Environmental Affairs and is an entrepreneur herself, launching Lectio, LLC in 2015 to provide an assistive learning technology for children with dyslexia and ADHD.
Mark brings over 20 years of experience in the human and animal health industries and has held a variety of leadership positions, including C-level and Board roles, in start-ups through larger corporations. His forte is evaluating, initiating, managing, funding, and growing new business ventures from inception through exit.
Mark has broad, international experience in medical device (Biomet, Zimmer, Tornier), pharmaceutical / biotech (Roche), life-science (Vanderbilt University Tech Transfer) and Government (US DOE/Battelle) sectors. Mark’s expertise spans marketing, sales, brand / product management, project management, R&D, clinical, and business development (M&A, licensing) fields, among others. Specific to medical device, Mark has worked across craniomaxillofacial, pediatrics, plastic surgery, cardiothoracic / cardivascular, hips, knees, shoulders, foot and ankle and regenerative medicine. Products have ranged from pre-operative technologies, to implants (including biologics, synthetics and xenografts), and delivery technologies (robotics, patient specific instruments, computer assisted surgery, injectables, disposables, etc).
As an entrepreneur, Mark served as CEO, Co-founder, and Board Member for Owl Manor Medical, LLC, an animal heath biologics / medical device company with a focused regenerative medicine portfolio targeting equine and companion animal joint and soft tissue preservation. Following a successful Series A financing round, Owl Manor grew in both revenues and profitability through its globally recognized portfolio. In addition to building a direct US / Canada sales channel, Owl Manor established a successful international business through a combination of distribution and direct sales across Europe, Middle East, Australia, and Mexico. Founded in February of 2015, Owl Manor was acquired on June 1, 2021 by Zoetis, the World’s Largest Animal Health company.
Mark holds an MBA from Vanderbilt University and a B.S. with honors from Purdue University. Mark’s interests include fitness, the outdoors, music, and travel.
Roy has over 30 years of executive experience in orthopedic product development and manufacturing to his credit. He spent the last 9 years with Medtronic in a variety of manufacturing engineering leadership roles of increasing responsibility, culminating in the position of Senior Director of Manufacturing/Site Leader, where he was responsible for overall operations performance, including strategic planning, budgets, compliance, and talent development for the 500+ person operation. During Roy’s leadership, the plant transitioned to a high mix/low volume operation, was voted as one of Indiana’s Best Places to Work and received the 2011 AME Manufacturing Excellence Award. Roy has over 20 years of experience in leading new product development efforts in the sports medicine, extremities, trauma, CMF, hip and knee fields at DePuy, Biomet and Zimmer and is a named inventor on 14 US patents. His most recent position in product development was Director of Global Development – Extremities, at Zimmer, where he and his team were responsible for a steady cadence of new products that contributed to a 5X increase in revenues over a five-year period. Roy is also a successful entrepreneur – he founded and led an orthopedics company focused on products for veterinary use which was acquired six years later. Roy recently established his own consulting firm and enjoys working with clients to mold ideas into commercialized products.
Roy’s educational background includes a Bachelor of Science Degree in Engineering Physics from Miami University (of Ohio) and a Bachelor of Science Degree in Biomedical Engineering from Case Western Reserve University.
Daniel Williman has 15 years of experience in the medical device industry. He started his career as a product development engineer and then moved into regulatory affairs leadership roles at Zimmer and DePuy Synthes. Daniel formed his own regulatory affairs consulting business in May 2019, with a goal of helping medical device companies bring innovative products to market and maintain regulatory compliance. More recently, he joined the AcceLINX team as a subject matter expert to assist their clients.
Throughout his career, Daniel has specialized in U.S. and EU regulatory strategy development and execution. He has been responsible for U.S. Pre-Submissions, U.S. 510(k) clearances, U.S. PMA Supplement approvals, a U.S. IDE approval, and various EU Design Dossier approvals and Technical Files.
Daniel’s educational background includes a Bachelor of Science Degree in Bioengineering from the University of Toledo with a minor in Business Administration. He holds a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.