MATRIX MEDICAL DEVICES - Key Persons
Jaclyn is a biomedical engineer with 3 years of experience in medical device development. She has spent her career working with start-up medical companies and thus has a broad range of experience in many aspects of product development. She has experience in both product design and quality, and can provide support with a variety of tasks such as development of user and product requirements, risk analysis & management, SOLIDWORKS services, and regulatory submissions.
Prior to Matrix, Jaclyn led the engineering effort for Back 2 Basics, a start-up orthopedic company focused on sterile-packed spinal implants. While at Back 2 Basics, Jaclyn was responsible for new product development in all phases; establishing user and product requirements, creating design output documents and drawings, managing V&V plans, and supplier management. She also supported Quality efforts with establishment of new procedures and increased CAPA and supplier management. In her time with the company, the small team obtained 510(k) clearances for two products, one being the first carbon composite spinal rod cleared as an adjunct in the treatment of spinal indications, and successfully sold the company assets to an acquiring party.
Since joining Matrix, Jaclyn has continued to develop a diverse skillset, supporting activities including Small Business Innovation Research grant applications, development of 21 CFR-compliant clinical study quality management systems, and IDE applications.
Jaclyn earned a Bachelor of Science degree in Biomedical Engineering with honors from the University of Akron.
Jaclyn is a biomedical engineer with experience in medical device development.
Job Titles:
- STRATEGIC PARTNERSHIPS, ADVISOR
Jeffrey Lietkze brings over 25 years in the medical device industry. As an advisor, Jeffrey's work supports and catalyzes business development, revenue growth, transactions, operations, and strategic partnerships. Jeffrey previously served in business development and legal leadership roles with medical device companies STERIS Corporation, Integra LifeSciences Corporation, and Theken Group. After launching in the 1990s, each of these three ventures wrote exemplary tech-startup stories: STERIS and Integra have become publicly-traded $1+ billion multinationals, and Theken's first exit closed for approximately $200 million in 2009 (a second closed in 2020, and others continue to grow).
STERIS, Integra, and Theken blend healthcare innovation with resolute leadership, generating sustained successes. They inspire medtech leadership. Solving and building, these "teams" improve lives of patients-in-need by scaling advanced technologies.
A Cornell Law graduate with economics degrees from the University of Akron (M.A.) and The College of Wooster (B.A.), Jeffrey values education and giving-back to communities. He was the first in his family to graduate from college, reinforcing a respect for America and the value of opportunity. Jeffrey volunteered for five years as an Adjunct Professor at Case Western's School of Law, and Weatherhead M.B.A. program. He delivered early-stage business and technology courses: Representing the Startup Internet Company, Advanced Contracts for E-commerce, and Digital Business & Law.
Job Titles:
- Senior Vice President, Regulatory and Quality
Meera Juneja has over 20 years of experience in the medical device industry spanning from start-ups to established medical device companies, with special emphasis in the areas of quality assurance and regulatory affairs.
Meera joined Matrix Medical in 2015. During her time at Matrix, she has implemented numerous Quality Management Systems, assisted Clients in achieving CE Marking and FDA Clearance for their devices, as well as ISO 9001:2015, ISO 13485:2016 and MDSAP Certification of their Quality Systems. Meera has also provided support for Clients during Notified Body Audits and FDA Inspections, as well as Annual Internal Audits. In addition, she serves as a virtual Quality and Regulatory Lead for several of Matrix's Clients.
Meera received Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professionals Society (RAPS) in 2017. She also received British Standards Institution (BSI) ISO 13485:2016 Lead Auditor Certification in 2020.
Prior to joining Matrix, Meera served as Director of Regulatory Affairs and Quality Assurance at Complion, Inc.. She led the software validation effort to ensure compliance to 21 CFR Part 11 for electronic records and electronic signatures during the development of a comprehensive regulatory e-System to efficiently manage clinical trial documentation at academic medical centers, community health systems and research sites. Additionally, Meera developed various e-System modules for FDA submissions.
Meera's prior experience as Manager, Regulatory Affairs at Frantz Medical Development, Ltd., encompassed the responsibility of the company's Management Representative and regulatory affairs representative for medical device product development cross-functional programs in the areas of interventional cardiology and orthopedics. Meera was also responsible for establishing and maintaining the international and FDA regulatory requirements for the company's infusion pump and cannula product lines. During her tenure, Meera streamlined and maintained the company's Documentation Control and Management Review processes. Meera also served as a member of the Corrective Action Board in which she was actively involved in the identification and implementation of corrective and preventive actions. As the Management Representative, Meera was also responsible for leading third-party and ISO/FDA audits and ensuring QSR requirements were effectively established and maintained.
Meera has also held positions at Imalux Corporation, a company focused on pioneering medical imaging devices based on optical coherence tomography, and STERIS Corporation, a global leader in infection prevention, contamination control, surgical and critical care technologies.
Meera received a Bachelor of Science from John Carroll University.
Job Titles:
- Mechanical Engineering Director
Paul has over 20 years of industry experience specific to medical device engineering. His knowledge in Design & Development Engineering; along with applied statistics and raw material & manufacturing knowledge; have developed an extensive skill range. His experience includes development of user and product requirements; risk analysis; product design; CAD; finite element analysis; statistics; plastic and metal materials; design for manufacturability; part qualification; pilot builds; product verification and validation; benchtop, cadaver, in-vivo, and usability testing.
Paul has held engineering leadership and managerial roles at Frantz Medical Development and Johnson & Johnson, Ethicon Endo-Surgery. Over the past ten years, Paul has been personally responsible for managing and completing new product development projects, including a spinal implant device and instruments and a cardiovascular interventional guidewire and catheter system. As a Program Manager, Paul is responsible for developing schedules, establishing the critical path, and coordinating activities with internal and external engineers, cross-functional team members, and suppliers. Paul also plays an active Mechanical Engineering role with development projects - including SolidWorks 3D modeling, verification and validation method development and criteria establishment, and ensuring a successful design transfer by working closely with production on assembly procedures, fixtures, and tools, and pilot production qualification. Paul has managed a patent portfolio, as well as drafted and filed multiple patent applications to strengthen coverage and block competition.
Within the area of Regulatory Affairs and Quality Systems, Paul has established Quality System Design Control and Risk Management Procedures, as well as generating supporting objective evidence (e.g., Design History Files, Risk Management Files). These procedures have successfully passed audits by FDA, ISO notified body, and large company distributors, e.g., Abbott, CooperSurgical, and Medtronic.
Paul is also skilled in preparing research and product development grant applications, including solid research plans, establishing leading clinical and research teams, as well as budget and schedule development. His grant preparation skills have been demonstrated by successfully achieving a Cleveland Clinic Global Cardiovascular Innovation Center ("GCIC") grant, NIH Small Business Innovation Research ("SBIR") grant, as well as an Ohio Third Frontier Grant, totally more than $1.5 million dollars in non-dilutive funding.
Paul holds multiple patents for novel design and technology. In addition, he has contributed to publications on prototyping, design and machine tool monitoring.
Paul earned his Master's and Bachelor's degree in Mechanical Engineering with honors from University of Illinois.
A Regulatory Affairs and Quality Systems professional in the medical device industry for over 25 years, Raymond Ursick has specific skills with regard to FDA regulations and international medical products regulations, regulatory affairs, regulatory compliance, ISO 9001 and ISO 13485, quality systems, and Total Quality Management (TQM). He has obtained FDA regulatory approvals for diagnostic imaging devices, neurological devices, cardiovascular devices and cardiovascular implants, sterilization devices and other infection control devices, surgical devices, dental devices, general hospital and personal use devices and critical care monitoring devices. Additionally, he has led successful programs to achieve ISO 9001 and ISO 13485 certification, to obtain CE Marking and to achieve Quality Awards using Malcolm Baldrige criteria.
Prior to beginning his consulting practice Raymond worked at Johnson & Johnson for eighteen years at three different operating companies, where he held various executive positions in Regulatory Affairs and Quality Systems. He then worked at STERIS Corporation for six years in the position of Vice President Regulatory Affairs and Quality Systems.
Ray Ursick is a Regulatory Affairs and Quality Systems professional that has been in the medical device industry for over 25 years.
Ruth has an accounting degree from GA State University and has over 20 years' experience working as an accountant prior to coming to Matrix Medical Devices. She has experience in corporate and government accounting. She has worked with Matrix Medical Devices since January 2022.
Job Titles:
- CEO
- Founder
- Founder and CEO / Matrix Medical Device Founder and Visionary, Stephanie Harrington Has over 25 Years of Management Experience in the Medical Device Industry
Matrix Medical Device founder and visionary, Stephanie Harrington has over 25+ years of management experience in the medical device industry with expertise in regulatory affairs, quality systems, product development, manufacturing, and clinical efficacy and market adoption studies. With strong technical skills, Stephanie has helped Companies and Clients establish savvy regulatory strategies that align with both short-term and long-term corporate objectives and are optimized to achieve marketable claims with the lowest regulatory risk, supported by achievable and applicable performance requirements and tests.
Over her career, she has prepared or overseen more than 30 medical device regulatory pre-market submissions with successful market approvals - FDA, CE, Australian TGA, Canada Licenses - over a range of medical device indication, complexity and risk, both therapeutics and diagnostics, e.g. IV Administration Sets, Arthroscopic Cannulas, Infusion Pumps, Endoscopes and Accessories, Temperature and Wellness Wearables, Novel and Traditional Imaging Devices, Interventional Cardiology, Spinal Implants and Sterilants/Sterilizers.
Stephanie has also established from the "ground-up" more than 30 FDA 21 CFR 820 and ISO 13485 Quality Systems, with many more remediated and streamlined, across small, mid, and large Companies. These Quality Systems, with well-practiced "objective evidence", result in successful audit results from FDA, Notified Bodies, and "Big Ten" Medical Device Companies, including, as example, Medtronic and Abbott.
Through these experiences, Stephanie has built mutually-respected, collegial relationships with FDA, other Regulatory Agencies, and leading EU Notified Bodies such as BSI. Her experience, competency, technical understanding, and Regulatory Body relationships result in more efficient and successful Client pre-market clearances and approvals as well as QS audits. While some Consulting groups attempt to insert themselves "indefinitely" with Clients, Stephanie strives to use these Milestone deliverables as opportunities to identify potential internal Client Regulatory and Quality champions, to train, mentor, and grow the Client's Regulatory and Quality organization, with our ultimate Matrix goal of the Client "graduating", with less or no Matrix support needed the next time.
Prior to forming Matrix Medical in 2013, Stephanie served as Chief Operating Officer of Frantz Medical Development Ltd., responsible for new product development, manufacturing and corporate regulatory and quality affairs. Prior to joining Frantz Medical, Stephanie served as Vice President and Chief Regulatory and Clinical Officer at Imalux Corporation, a start-up optical coherence tomography imaging company, establishing the company's Quality System, preparing and achieving multiple 510(k) clearances, as well as the first "OCT" FDA Product Code for non-ophthalmic use. Prior to Imalux, she was Director in Research and Development at STERIS Corporation, responsible for product development of medical device reprocessing systems.
Stephanie earned a Masters of Science degree in Chemical Engineering from Stanford University and holds a Bachelors of Science in Chemical Engineering, Summa Cum Laude, Honors in Engineering, from the University of Maryland.
Trevor O. Jones is a lifelong engineering pioneer and founded the International Development Corporation, a technology consulting company, in 1987.
Most recently, Mr. Jones served as chairman and chief executive officer of ElectroSonics Medical Inc., a biomedical device company he co-founded in 2007. Mr. Jones earlier founded BIOMEC, a company involved in the development and commercialization of biomedical devices, and served as its chairman until the firm was acquired by the Texas-based firm Greatbatch Inc. Mr. Jones also held leadership positions in such companies as TRW Inc., General Motors and the Libbey-Owens-Ford Co., a producer of flat glass for the automobile and construction industries. While at GM he directed such major initiatives as the B-52 bombing navigational system production program, advanced military avionic systems and Apollo lunar and command module computers.
Mr. Jones has received 16 patents, and has lectured and authored papers on automotive electronics, occupant safety, fuel cells, international human resource management and entrepreneurship. He also has received many of the most esteemed awards in innovation and industry in the U.S. and Great Britain. In 1982, for example, Mr. Jones was elected to the U.S. National Academy of Engineering, among the highest honors awarded in the field. In addition, he is also a Lifetime Associate of the National Research Council and Life Fellow of the American Institute of Electrical and Electronics Engineers. Moreover, he is a fellow of the British Institute of Electrical Engineers and a fellow of the Royal Society for the Encouragement of Arts, Manufacturing and Commerce (FRSA).
Mr. Jones received the U.S. Department of Transportation of Safety Award for Engineering Excellence in 1978, and, in 1991, received the H.H. Bliss Award from the Center for Study of Responsive Law. Both awards recognized his pioneering contributions to automotive inflatable occupant restraint systems development.
In 2006, Cleveland State University awarded Mr. Jones an honorary Doctor of Science degree and cited him for outstanding developments in fuel cell and biomedical device technologies. In 2014, Mr. Jones was named a 2014 fellow of the National Academy of Inventors (NAI), a distinction awarded to esteemed innovators and inventors worldwide.