IMPACT ACCELERATOR
Accelerating
Medtech
How We Work
Years Of Research Experience
Breadth and Depth
Through our deep team of experts, IMPACT delivers solutions across a broad spectrum of development, whether it be stage or phase of study, product, or company type.
Problem
Medtech Companies Face Massive Barriers
Start-up companies face massive barriers to executing well-designed and effective pre-market clinical trials compared to larger corporate entities. The myriad of regulatory expertise, clinical research expertise, market access knowledge, and the large financial commitment required to design and execute clinical trials for regulatory approval on new products are often the downfall of new ventures who face limited funding, short runways, and who simply cannot afford any missteps in the process.
Solution
Bench to bedside.
The IMPACT Accelerator supports startup ventures through every stage, from ideation to market launch. Companies that conduct their clinical trials through the IMPACT program receive unique research plans outlining the steps required throughout the entire process, have access to in-house and on-demand regulatory and quality management consultation services and software, and are able to tap into several third-party service providers who partner with IMPACT (software development, clinical monitoring, statisticians, prototyping, economic analyses, etc.) to effectively and efficiently generate the deliverables required to bring their health innovation to market.
Tailored programming for your venture
From proof-of-concept to clinical trials.
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. IMPACT’s experienced team will guide you and your team through the process. Whether it’s a small early pilot or a large pivotal clinical trial, we will provide you with a cost-effective solution.
From research to commercial launch, we got you covered.
Our Venture Services
Explore our Venture Services
We are dedicated to empowering startup ventures by providing comprehensive support in navigating clinical trials, regulatory compliance, and market access.
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Cost-effective clinical trials
Founder resources
Our commitment to founders & patients
Our mission at IMPACT is to lower barriers for medtech founders to allow them to bring innovative, life-saving, solutions to market faster and more cost-effectively.
IMPACT provides clients with a full suite of clinical trial services encompassing the workflow from planning and design through execution and study closure. These trials vary in size from small pilots (e.g., n=10) to full-scale pivotal trials (e.g., n>100). IMPACT designs trials for its clients such that clinical trial endpoints are met for all target markets (e.g., US FDA and Health Canada requirements), as well generating data to support the business case for the innovation (e.g., cost benefit analysis to support procurement).
Tailored Regulatory, Audit, Compliance and reporting (TRACr; pronounced [trækə(r)]) is a proprietary software platform that has been developed by IMPACT as a tool to support ventures with regulatory planning. TRACr provides an organized approach to regulatory submissions and clinical trial planning – it automates workflows, helps track and manage records, and is structured to satisfy the submission requirements of the US FDA and Health Canada. Use of the TRACr tool allows for reduced human capital and ensures that nothing gets missed. and requirements associated with clinical trials and market approval of their products.
Implementation of a Quality Management System (QMS) is a requirement to bring health products to market that is mandated by regulatory bodies. In the United States, that includes compliance with 21 CFR 820, in Canada, Europe, and other jurisdictions this often means compliance with standards such as ISO 13485 for medical devices. Conformity with these standards can be a confusing, complex, time-consuming and costly process for early-stage health ventures, so IMPACT provides services and tools to enable clients to meet these standards efficiently and effectively.
Join our medtech network
Intake form
Fill out our venture intake form, give our team a bit of background on your venture.
Introductory meeting
Meet with one of our venture navigators, with background in your clinical indication
Join our medtech network
Review our commercialization agreement and an actionable go-forward plan
Our clients
Medtech Startups
Network Trial Sites
Advisors
Meet one of our venture navigators
IMPACT is a medtech accelerator program dedicated to empowering startup ventures by providing comprehensive support in navigating clinical trials, regulatory compliance, and market access.
