Randy AuCoin is a seasoned clinical executive with broad experience in all aspects of medical device operations. He started his career developing software in a medical device start-up and quickly realized his love for early stage companies and medical devices. Randy’s career is reflective of his passion for growing early stage medical device companies and spans a broad range of operational and managerial roles. Prior to Exact Imaging, he was a key executive in three other early stage ventures, helping to grow the companies’ valuation resulting in four liquidity events including one company which was sold twice based on the fundamental technology which Randy helped to develop and commercialize.
Randy is President and CEO of Exact Imaging, responsible for the company’s strategic direction, key operations and overseeing the development and global commercialization of its ExactVu™ micro-ultrasound platform. He joined Imagistx (now Exact Imaging) in 2011 as COO. In 2013 he became President and CEO, successfully restructuring the company into a Canadian entity, driving the Company’s strategy and fundraising, and building the Company’s management and operational teams. He also architected and led the company’s multi-site clinical trial. Randy has also successfully raised over $43 million in financing.
Prior to Exact Imaging from 2003 – 2011, Randy was Vice President, Quality Assurance and Regulatory Affairs at VisualSonics (sold in 2010 to Sonosite (SONO: NASDAQ)) and was responsible for the development and execution of all quality assurance and control efforts as well as directing all regulatory affairs and clinical programs. He directed VisualSonics’ achievement of ISO 9001 quality certification within its first 2 years of operation. He also led all clinical investigations including the original efforts into successfully validating the Imagistx’s opportunity leveraging the VisualSonics technology for prostate imaging. He also contributed to the quality system that successfully delivered over 1,500 VisualSonics high resolution-ultrasound systems with an extremely high-level of quality and customer satisfaction.
From 2000 to 2003, Randy was Manager of Engineering, QA & RA at Dicomit DICOM Information Technologies (acquired by Cedara software). From 1998 to 2000, Randy was a Y2K consultant with Ontario Hydro. Previously, from 1990 to 1998, Randy worked in cardiology as a principal engineer with Biomedical Instrumentation Inc. (acquired by American Home Products and re-branded as Quinton Electrophysiology Corporation). Quinton Electrophysiology was eventually acquired by Pruka Engineering.
Brian Wodlinger is a post-doctoral level biomedical engineer with 15 years’ experience in medical devices and biomedical research. Brian is VP of Engineering and Clinical at Exact Imaging, responsible for overseeing product development, clinical applications, physician training, and clinical evidence generation.
Prior to Exact Imaging, Brian held research positions at the University of Pittsburgh Medical Center and Case Western Reserve University. This research won Popular Mechanics Top Breakthroughs of the Year award and has been featured in the popular media on platforms such as CBS's "60 Minutes". Brian holds 8 patents in the medical devices space, has designed and executed more than 13 clinical trials and has authored more than 18 peer-reviewed research articles in prestigious journals such as The Lancet, and PLoS ONE.
Brian holds a PhD and MSc in Biomedical Engineering from Case Western Reserve University and BASc in Engineering Science from the University of Toronto.
Russell Daling is a highly experienced leader in medical device manufacturing and service. With over 14 years in a leadership role he has implemented advanced manufacturing systems, employee culture transformation and managed teams of up to 30 employees. As Director, Manufacturing and Service for Exact Imaging, Russell is responsible for overseeing the product manufacturing functions and providing service excellence to the Exact Imaging international customer base and distribution partners.
From 2003 to 2018 Russell authored, implemented and managed the ISO 13485 Quality Management System from initial certification through two major revisions for Widex Canada, a cutting edge medical device manufacturer. While serving as Production Manager at Widex, Russell lead a major operational transformation, consolidating core production and service activities to a central North American operations centre and consistently improved financial performance through lean initiatives in materials handling, process efficiency, and capacity planning.
Most recently Russell has served as Service Manager for Conavi, a cardiac imaging start-up in the role of service manager where he developed capability, strategy and processes for implementing the company’s service function. Russell is educated in electro-mechanical engineering and has continuously updated his knowledge and skills with an extensive record of ongoing educational achievements.
Kevin Maier is a leader in financial management and accounting with over 10 years of experience. As Senior Manager, Finance for Exact Imaging, Kevin is responsible for overseeing the company’s financial functions, including accounting, business support, treasury and tax.
Prior to Exact Imaging, Kevin served as Manager at Taylor Leibow LLP in the Assurance and Business Advisory practice, where he was responsible for leading assurance projects, employee training, and serving as an accounting, business and tax advisory resource to a wide variety of clients. He implemented new software systems, developed a robust staff training program and worked with his clients to strengthen their processes and controls. Kevin has obtained his Chartered Accountant designation and holds a Bachelor of Accounting from Brock University.
Sandy Smith is an experienced quality specialist with over 20 years’ experience in medical device development and manufacturing. Most recently, Sandy worked as an independent quality consultant, providing services that include development and execution of system testing plans, development of regulatory submissions, quality system management, development of risk management plans, and instructions for use. She has had a long-time consulting relationship with Exact Imaging and has worked with several medical device companies in the Toronto-area, including VisualSonics and MolecuLight Inc.
Prior to working as a consultant, Sandy held senior Verification and Validation positions at VisualSonics and Quinton Electrophysiology (later acquired by Pruka Engineering). Outside the medical device field, Sandy held software QA positions in a variety of consulting engagements and began her career at Delrina Inc. (later acquired by Symantec Corp.) in 1993 after graduating from Queen’s University in Kingston as a Bachelor of Science (Engineering).
As the Director, Verification & Validation, Sandy oversees all testing activities during the development of Exact Imaging medical devices and ensures adherence to prescribed testing guidelines and quality control procedures. Sandy supports all departments responsible for the design, development, manufacture, and support of Exact Imaging products.
Gwendolyn Pinto is an experienced Regulatory Affairs & Quality Assurance leader with more than 10 years’ experience in Medical Devices. As Director, RA & QA at Exact Imaging, Gwendolyn is responsible for global markets registration of Exact Imaging product lines, implementing continuous improvement opportunities to ensure compliance to national and global regulations and maintaining an effective quality management system.
Prior to joining Exact Imaging, Gwendolyn managed a cross-functional team at Laborie Medical Technologies Canada ULC. as a Regulatory Affairs Manager of Global Emerging Markets where she was responsible for the creation and management of global regulatory submissions to support product registration activities for Laborie and its acquisition companies in emerging global markets in Asia, Latin America, Middle East, Eurasia & Oceania, in addition to Canadian, USA & European markets.
During her time at Laborie, Gwendolyn spearheaded and closed out numerous quality management system projects, CAPAs, complaint handling and other supplier-related project management activities. She was the audit lead on many global regulatory body site audits from the FDA, Health Canada, ANVISA (Brazil), Japan, S. Korea and addressed responses to various Notified Body Technical File Audit assessments for Europe CE Mark. As the regulatory subject matter expert, Gwendolyn contributed to design & development, labeling, risk management, usability and clinical requirements for various new design projects and sustaining product design change control processes.
Gwendolyn is a certified internal auditor with hands-on expertise in leading companies to achieve compliance to the ISO 13485:2016, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745 & MDSAP regulations.
Gwendolyn holds a Master of Science (MSc.) in Regulatory Affairs for Drugs, Biologics and Medical Devices from Northeastern University in Boston, MA and a Bachelor of Science (BSc.) in Neuroscience and Health Studies from the University of Toronto.
