IMPACT MEDTECH
Clinical, Regulatory, and Quality Support for Medtech Innovation
IMPACT (Integrated Management Platform to Accelerate Clinical Trials) is an Innovate Calgary-born initiative that is supported by Alberta Innovates and the University of Calgary - Cumming School of Medicine. Using a regulatory-first and commercialization-oriented approach, IMPACT helps companies identify efficient development pathways, generate meaningful validation evidence through clinical trials, and navigate progression from early concept development through market access.
In addition to generalized regulatory, clinical, quality, and operational planning / execution support, IMPACT offers several focused programs aligned with different stages of technology development and commercialization.
Key Programs
Early Market Access Preparation (EMAP) | Early-stage regulatory, clinical, and commercialization planning designed to help companies identify efficient development and market access pathways prior to major investment and validation activities. |
Rapid Assessment of Medical Prototypes (RAMP) | Pilot and feasibility-focused support program to help companies generate clinically meaningful validation data, reduce development risk, and support commercialization readiness. |
Regulatory Assistance, Investigation Support and Execution (RAISE) | Integrated clinical, regulatory, quality, and operational support for companies advancing toward pivotal validation, regulatory submission, and commercialization activities. |
Who We Support
IMPACT supports MedTech, digital health, diagnostic, and emerging health technology companies across a broad range of development stages, from early concept and prototype development through clinical validation, regulatory submission, and commercialization.
- Early-stage startups and founders
- Companies strengthening funding applications and investor readiness
- Academic and translational research teams
- University-affiliated ventures and spinouts
- Independent Canadian and international companies
- Companies advancing pilot, feasibility, or pivotal clinical studies
- Companies evaluating lower-risk or non-regulated commercialization pathways
- Companies preparing for regulatory interactions and submissions
Why IMPACT?
IMPACT helps companies make efficient regulatory, clinical, and commercialization decisions using practical, least-burdensome approaches to validation and market access. Unlike traditional consulting or CRO models, IMPACT works collaboratively with companies through flexible, sponsor-integrated support tailored to company stage, internal expertise, and development goals.
Our approach integrates regulatory strategy, clinical development, quality systems, operational planning, and ecosystem coordination to help companies reduce fragmentation, identify critical gaps early, and progress efficiently toward validation, market access, and commercialization.
Key differentiators:
- Integrated regulatory, clinical, quality, and commercialization planning
- Flexible support models aligned with company stage and resources
- Practical, execution-oriented development strategies
- Ecosystem-connected navigation and partner coordination
- Support spanning concept development through market access and post-market growth
1. EARLY MARKET ACCESS PLANNING
IMPACT helps companies identify efficient regulatory and commercialization pathways early, reducing development risk, avoiding unnecessary costs, and supporting informed strategic decision-making before major investment.
2. REGULATORY STRATEGY AND QUALITY SYSTEMS
IMPACT supports development of scalable regulatory and quality strategies aligned with product maturity, target markets, evidence requirements, and commercialization goals.
3. CLINICAL DEVELOPMENT AND VALIDATION
IMPACT helps companies generate the clinical evidence needed to support regulatory submissions, market adoption, and commercialization through strategically aligned clinical development and trial execution.
4. VENTURE VAVIGATION
IMPACT helps companies identify development gaps, solve strategic and operational challenges, and connect with the right resources, partners, and expertise at the appropriate stage of development.
IMPACT helps companies navigate the path to market through integrated clinical, regulatory, quality, technical, and commercialization planning across the product lifecycle.
Work With Us
Whether you are exploring early development planning, preparing for validation activities, or advancing toward regulatory submission and commercialization, IMPACT can help identify appropriate next steps and support pathways aligned with your stage of development.
To discuss potential collaboration or request additional information:
impact@ucalgary.ca
Companies interested in participating in the Early Market Access Preparation (EMAP) Program, a subsidized Alberta Innovates-supported initiative providing early-stage regulatory, clinical, and commercialization planning support for health technology companies, are encouraged to complete the EMAP intake form.
Our Team
Leadership
Dr. Derek Exner, MD, MPH, FRCPC, FACC, FHRS is Executive Director of the IMPACT program and inaugural Associate Dean of Innovation and Commercialization for the Cumming School of Medicine at the University of Calgary. A practicing cardiologist, clinical trials expert, and Canada Research Chair in Cardiovascular Clinical Trials, his work focuses on advancing health technology innovation through clinical validation, regulatory strategy, and commercialization. Dr. Exner has authored over 300 publications and serves as Chief Medical Officer for HelpWear Inc.
Matt Rieger, PhD, ACRP-CP®, is Program Manager and Clinical Development Lead for the IMPACT program, supporting companies through integrated clinical development, regulatory strategy, and trial execution. With over 15 years of research experience spanning cardiovascular, respiratory, neurovascular, pediatric, and surgical/device research environments, his work focuses on translating early-stage technologies into practical validation and commercialization pathways through evidence-generation strategy, operational planning, and early-phase medical device trial management.
Pamela Ovadje, PhD, RAC (Devices), is Senior Manager, Regulatory and Quality for the IMPACT program, supporting health technology companies through regulatory strategy, quality systems, and global pre-market planning. Drawing on experience across preclinical research, scientific writing, and startup-focused regulatory support, her work focuses on helping companies navigate complex regulatory requirements while aligning commercialization, compliance, and risk-management objectives.