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IMPACT

We help you achieve market approval of your health technology faster, with less capital.

About the program

The Integrated Management Platform to Accelerate Clinical Trials (IMPACT) provides an accelerated path to health innovation market approval for less capital. The IMPACT program will help your health-tech or biomedical early or mid-stage venture conduct clinical trials and secure regulatory approvals for your new health-related inventions.

Founded in 2019, our team and partners at Innovate Calgary have over 300 years of combined experience in trial design, management and execution, regulatory affairs and quality management, biostatistics, data analysis, IP and business development. With our help, several ventures have achieved FDA and Health Canada product approvals and you can be next!

IMPACT is the recognized clinical trial vendor for the Creative Destruction Lab, and has partnerships with McMaster Innovation Park and Applied Pharmaceutical Innovation. While we are proud to support our local Calgary innovation community, over half of our client ventures originate from across Canada, the United States and the United Kingdom thanks to our growing reputation.

Bridging the gap between innovation and market readiness

Medtech Companies Face Massive Barriers

Planning the Path to Market:

From navigating complex regulatory requirements to securing clinical evidence and funding, the road ahead can be expensive and time-consuming. As investors become increasingly cautious with early-stage companies, having a well-defined and strategic path to market is more important than ever.

A clear, detailed roadmap—complete with realistic timelines and budgets—is essential not only for attracting capital but for efficiently allocating resources throughout the development process. A comprehensive plan demonstrates to stakeholders that the device is being developed with a thoughtful, calculated approach, reducing risk and maximizing potential for success.

Developing an appropriate research strategy:

Start-up companies face significant challenges when it comes to executing well-designed and effective pre-market clinical trials. Clinical research for regulatory approval is not just about meeting the minimum safety and efficacy requirements—it must also address critical marketing needs and commercial considerations. For startups with limited funding and short timelines, any misstep can be costly.  Making a comprehensive and well-executed clinical plan a key factor in their success.

The Impact Solution

We demystify regulatory processes, accelerate clinical trials and provide a comprehensive suite of services tailored to support startups through their various stages.

At early stages, we provide support in developing a comprehensive regulatory strategy to map out your path to market. This plan allows for identification of detailed milestones, as well as costs, timelines, and adaptable approaches to action.

When your device is ready for testing, our Rapid Assessment of Medical Prototypes (“RAMP”) and Regulatory Assistance, Investigation Support and Execution (“RAISE”) programs provide tailored solutions to meet your company’s needs. Whether it’s a small early pilot or a large pivotal clinical trial, we will provide you with a cost-effective solution.

What to Expect When You Partner With Us

Whether it’s end-to-end service, or just helping you work through isolated challenges, we act like an extension of your team to provide regulatory, quality, and clinical support- tailored to your needs.

Regulatory Support

Preparation and Planning

  • Device classification and confirmation with regulatory bodies
  • Regulatory pathways in different markets, with strategic considerations for ease of access and market impact
  • Identification of relevant standards, and support in pre-clinical/bench testing plan
  • Support in development and/or maintenance of your quality management system, and preparation for audits
  • Identification of preliminary budgets, timelines, and critical paths associated with each milestone.

Execution

  • Presubmission package preparation, correspondence and meetings with regulatory bodies, to streamline clinical and regulatory pathways
  • Development of an investigator’s brochure, and facilitation of necessary regulatory submissions approvals for testing
  • Medical device license applications with Health Canada and the FDA.

Clinical Support

Development

  • An expert Navigator assigned to your project
  • Comprehensive protocol development, trial design, budgeting, and forecasting
  • Alignment of clinical protocol with regulatory strategy and marketing goals
  • Facilitation of necessary regulatory and ethics approvals
  • Engagement of Key Opinion Leaders, trial investigators, and qualified trial sites
  • Connection with partner network and collaborators to take actionable steps on your plan

Execution

  • Support in study-startup, through site selection and initiation
  • Database development, validation, and management
  • Clinical trial management of operations, including data collection, safety monitoring, quality assurance
  • Trial close-out, statistical analysis, and scientific writing

Our ideal partners

  • Have a health-tech product offering (e.g., device, diagnostic, combination product, SaMD) at TRL 5 or above
  • Are ready to engage in planning human trials and/or regulatory applications
  • Have secured funding to support clinical activities
  • Have defensible and secure IP

How to connect with IMPACT

For a no-cost consultation, send an email to impact@ucalgary.ca and we will follow up to schedule a meeting.

  • Providing information about your general needs (e.g., regulatory strategy/submissions, clinical strategy/trial management, quality), will allow us to ensure the most relevant team members are available for the consultation. If you are unsure, no problem. Our job is to help you figure that out!
  • Providing a brief overview of your technology / device will also assist with our preparation for the meeting.

What to expect during the meeting:

  • If you have a pitch-deck, we will welcome you to (informally) share this with us.
  • We would like to hear about your product/project goals, and we will give you an overview on how we can help guide you along the path to market.
  • If our teams mutually determine that this will be a good fit, we can scope out project parameters, estimated costs, and provide further introductions to relevant team members.
  • If we are unable to directly provide the services you are looking for at the current stage, we are more than happy to refer you to one of our many collaborators.

Meet our team

Meet our consultants

Our partners

Our clients

Have questions about the program?

Contact Us