Joel Ironstone, BASc., RAC
Joel Ironstone is a medical technology development expert with ~20 years of experience developing novel medical technologies. His experience includes technical development, regulatory approvals and the design and execution of first-in-man and pivotal clinical trials. He has brought more than a dozen innovative healthcare products from concept through to commercialization, and has held executive positions as CEO, COO, VP Product Development, and VP Clinical and Regulatory Affairs at several medical technology companies.
Matthew Asselin, MASc.
VP Product Development
Matthew has over 10 years of experience in medical devices, in addition to two years of R&D at Sunnybrook Hospital’s Research Institute. Matthew was a founding member of Profound Medical Inc., a Class III medical device for treatment of prostate cancer under MR-guidance. During his five years at Profound, he actively designed several system components, managed multidisciplinary teams for HC/FDA submissions, and was instrumental in the successful completion of both pre-clinical and clinical trials in Germany and Canada. Matthew then took on a role at Philips Healthcare in their Ultrasound division where he managed a cross-functional, international team mandated with launching image fusion and image-guided navigation on Philips’ ultrasound systems. As Director of Engineering at CIMTEC, a medical device consulting firm specializing in imaging-related medical technologies, Matthew managed an engineering department of 15. During his tenure, he introduced several processes (ISO 13485, ISO 14971, IEC 62304, project management, etc.) to better help customers develop their medical technologies for commercial use.
Abhi Pushparaj, Ph.D
VP Clinical and Regulatory
Abhi is a neuropharmacologist with extensive experience in the clinical evaluation and regulatory approval of a variety of therapeutic and diagnostic medical technologies. He has particular experience in clinical trial design and execution, and pre-submission engagement with both the FDA and Health Canada, and he has authored successful class II, III, and IV regulatory submissions for a variety of diagnostic and therapeutic products.
Charusheila Ramkumar, MD, PhD
Charu Ramkumar is a physician-scientist with over 10 years of experience in oncology diagnostics. She received her MD from India and a PhD in Biomedical Sciences, specializing in cancer genetics from the University of Massachusetts Medical School. Prior to joining IPD she worked at biotech start-ups in senior scientific roles and conceptualized, developed and commercialized novel oncology-based testing solutions. Charu is experienced in clinical development and regulatory evaluation of medical devices and IVDs.
Martin Musiol, BSc., CBA
Medical Device Consultant & Management Representative
An alumnus of the University of Toronto’s Neuroscience program and the MaRS Discovery District’s “Studio Y” Fellowship for Ontario’s top young leaders, Martin spent a year working at the intersection of technology and public health before joining IPD. Martin is both a Certified Biomedical Auditor (CBA) and TPECS Lead Auditor who has written and established several ISO 13485:2016, CMDR, and FDA QSR compliant Quality Management Systems (QMS). He directed the establishment of IPD’s internal QMS and now serves as our Management Representative. A dynamic asset to our team, Martin has managed turnkey product development projects, led Health Canada and CE Mark regulatory submissions, created Clinical Evaluation Reports for Technical Files, clinical feasibility and pilot studies, and designed and executed usability evaluations for a range of medical devices.
Martin Rozee, P. Eng, MASc.
Director of Software
Martin is a software craftsman ~20 years of experience in software and systems development for medical devices. His leadership of teams at companies including Thornhill Research, Perimeter, and Z-Tech has yielded a track record of products with successful premarket clearances. Managed software engineering and architecture projects for a range of cutting-edge technologies, including breast cancer screening, tissue imaging, and fully integrated life support systems designed for use in combat. He is a professional engineer with a Master’s degree in Computer Engineering from University of Toronto, and is a graduate of Systems Design Engineering at Waterloo.
Catriona Boyd, P.Eng, CBA
Senior Medical Device Consultant
Catriona has been helping companies bring innovative medical technologies to the market for over 9 years. Catriona has led Quality/Regulatory departments at Thornhill Medical (formally Thornhill Research) and ChipCare Corporation, with experiences spanning from early stage research and development through the product life cycle to post market surveillance and reporting. She has generated and maintained Quality Management Systems compliant to ISO 13485, EU MDD/IVDD, Health Canada Canadian Medical Devices Regulation, FDA Quality System Regulations and participated in the preparation and successful marketing applications to the FDA, EU, Therapeutic Goods Administration (Australia), and Health Canada. Catriona has a Bachelor of Applied Science in Engineering Science, Biomedical Engineering from the University of Toronto, a professional engineering designation (P.Eng), and is certified as a Certified Biomedical Auditor (CBA), TPECS Lead Auditor, and ISO 13485:2016 Internal Auditor.
Jess Hatch, Ph.D
Jess is a clinical pharmacologist with over 7 years of experience in interdisciplinary health research and clinical trial design. She completed her doctoral research at the University of Toronto, in the department of Pharmacology and Toxicology, specializing in psychiatric disorders and cardiovascular disease. She has extensive experience in both preclinical and clinical settings, on research topics ranging from medical devices and patient-centered outcomes in the treatment of vascular pathologies to animal models of addiction. Jess is highly skilled in taking concept to clinical trial design, ethics board communications and applications, data management, and statistical modeling techniques.
Drew Miller, P.Eng BASc
Medical Electronics Consultant
Drew Miller is a medical electronics expert with over 20 years of product development experience. He has brought more than 30 products from concept through to production including class I, class II, and class III medical devices in imaging, emergency medicine critical care, cardiology, and neurology. Drew’s technical expertise includes high power systems (up to 5kW), lithium battery systems, MR compatibility, safety critical software systems and motor control.
Chris Gillespie, P. Eng, BASc
Senior Mechanical Engineer
Chris is a seasoned product development professional who has driven novel medical devices through all life cycle phases. He has over 15 years of experience in the industry, previously holding positions as a hardware developer and lead designer at Sentinelle and Philips Healthcare. Chris is an expert in creating prototypes and production-ready models designed for manufacturing, and has executed design for injection molding and supply chain sourcing for surgical imaging and augmentation technologies. He is a Professional Engineer and holds a BASc from Queen’s University.
Michael Klein, MASc, P.Eng
Medical Device Consultant
Michael Klein has been successfully developing innovative medical technologies for ten years by working at the interface of engineering and the life sciences. Michael spent six years at Thornhill Medical building novel respiratory devices to improve mechanical ventilation, inhalational anesthesia delivery, and non-invasive hemodynamic monitoring. His developments led to multiple patent applications and commercialization opportunities for Thornhill Medical. Michael continued his career as Assistant Director of Research and Development at Xagenic, where he designed new assays and biosensors for a point-of-care molecular diagnostic platform. As a consultant, Michael applied his unique combination of design, research, and strategic thinking skills to lead projects in a variety of fields such as molecular diagnostics, respirology, cardiology, and gastroenterology, helping numerous companies successfully navigate the path to market. Michael holds a Bachelor of Applied Science degree from the University of Waterloo and a Master of Science degree with a research focus in respiratory physiology from the University of Toronto.
Product Development Technician
Danny has a background in electrical engineering, to be completed, and experience in a medical device start-up creating an incontinence management device for senior citizens in long term care homes. He was part of the research and design teams, with a focus in verification and validation of the system through its various prototype stages. The start-up company was acquired in late 2016 after 2 years of development, where Danny continued to work with the new team to integrate the device with their systems. Danny has experience in verification and validation of medical devices to ensure devices meet system requirements, providing the industrial/mechanical, electrical, software teams with the information necessary to make improvements to the system.