Success Stories

“Avania provided electrical system design, firmware development, and complete product development management to transform our wheelchair repositioning concept into a market-ready medical device. We needed a reliable, regulatory-compliant solution for demanding long-term care environments, and Avania delivered exceptional technical work while seamlessly managing the entire process. The results speak for themselves: Paraglide® launched as the world’s first automated wheelchair repositioning system, sold out our initial production run, won ‘The Pitch’ competition at OLTCA 2023, and is now eliminating caregiver injuries across Canadian care facilities. Avania’s technical excellence and project management were critical to bringing our vision to life.”

Matthew MacKenzie
President, MacKenzie Healthcare Technologies, Nova Scotia

“Exceptionally collaborative and pragmatic. Avania brought senior, device-savvy guidance, anticipated FDA’s perspective, and felt like an extension of our team. [Avania helped with] a well-structured Q-Sub package, investor facing materials, EFS study protocol, and a clear roadmap with actionable next steps for IDE/EFS. We left the process with alignment on milestones and more confident in the path forward. Avania strikes the right balance of speed and rigor. Highly recommend them for early-stage medtech teams navigating complex regulatory paths.”

Ashley King
Chief Commercial Officer, Turing Medical

“My four decades of experience in interventional cardiology and clinical research have reinforced the importance of working with experienced partners who truly understand the complexities of trial execution. Avania consistently delivers comprehensive, tailored, end-to-end solutions that make the difference between a good study and a great one, meeting all the goals on time. Their team is thorough, collaborative, and deeply committed to quality when navigating high-stakes clinical programs. Partnering with Avania means knowing the details are handled and the science is respected.”

Dr. Steven Bailey, MD
Former Chairman of the Department of Medicine and the Malcolm Feist Chair of Interventional Cardiology
LSU Health Shreveport

“Avania supported us through one of the most critical phases of our journey — preparing our regulatory submissions to both Health Canada and the FDA, and acting as the contract research organization (CRO) for our clinical trial with Unity Health. We turned to Avania because we needed a partner who could help us navigate complex regulatory pathways while keeping up with the fast-paced, resource-constrained environment of a startup. Our goal was ambitious: to move efficiently toward clinical validation and regulatory clearance without losing momentum.

From day one, the Avania team felt like an integral part of Remedy Robotics. They were exceptionally knowledgeable, creative, and detail-oriented — but also scrappy and tenacious in the face of . They didn’t just give us advice; they worked shoulder to shoulder alongside us, solving problems as they arose and pushing our program forward. Thanks to their guidance and hands-on collaboration, we were able to deliver a strong, well-supported regulatory submission and run a smooth, well-managed clinical trial. We’ve come out of the process not only with critical milestones achieved but also with a stronger foundation for future regulatory and clinical work.

We’re so grateful for Avania’s partnership and would recommend them wholeheartedly to any company looking for a CRO and regulatory consultant who truly feels like part of the team.”

David Bell
CEO, Remedy Robotics

“We interviewed a number of CROs before we selected Avania to help us conduct our medical device IDE trial. From inception to execution and closeout, we were continuously impressed with the team’s diverse skill set, responsiveness, and willingness to pitch in whenever required. The team is experienced and well credentialed, but we were most impressed at how whatever we asked, the Avania team delivered without any pushback. These trials are complex, often frustrating, and there are many ups and downs. I would trust Avania in a heartbeat for getting things over the line, on time, and on budget.”

Paul Komenda M.D., MHA, FRCPC, FASN
Chief Medical Officer, Quanta Dialysis Technologies Limited

“As a regulatory/clinical/quality scientist, I am not a linguistics expert best equipped to define all the adjectives (superlative, outstanding, etc.) that come to mind from working with Avania. What I can say is that Avania rocks! Avania has assembled an expert team, assisting me in our efforts to bring to market a medical device that had IDE clinical data and regulatory submissions from a previous manufacturer. From providing gap analyses, preparing IDE reports, and planning pre-submissions for getting our product across the finish line, Avania is proving to be invaluable in these efforts. Working for an orthopedic surgeon can be highly demanding and Avania is right there for every one of my inquiries — their responsiveness has made this a thoroughly enjoyable work effort. I look forward to working with Avania on the completion of this project and many more in the future.”

Patrick Balsmann
Unity HA Director Regulatory Clinical & QA

“As an early stage, MedTech startup, you are only as strong as your next round of funding. And no three letters give an investor more pause than “FDA.” Fortunately, months of collaboration with Avania helped produce a very successful Pre-Submission meeting, the results of which have become the cornerstone of our future fundraising efforts. Throughout the process, we have been pleased with not only Avania’s regulatory strengths, but also their understanding of the powerful stresses startups face. Bottom line: Avania has become a critical strategic partner in helping prepare the VentriFlo® True Pulse Pump for successful market clearance so we can fulfill our mission of providing improved healthcare options to some of the sickest cardiac patients while helping achieve lower overall total costs.”

Doug Vincent
President and CEO – Design Mentor

“Avania shows a passion for supporting companies as they develop their technologies to make an impact on healthcare and the marketplace. Avania has a deep pool of experience for developing effective and efficient regulatory strategy, clinical strategy, and protocol writing, as well as networking with KOLs. Avania understands the needs of a fast-paced young and growing start up, and provides their services in a courteous, supportive, and patient manner.”

Dustin Arless
Clinical Development at SoundBite Medical Solutions Inc.

“Our recent PMA submission and approval took eight months from filing to approval. We worked with Avania as a statistical consultant throughout the development and execution of the HeartLight pivotal clinical study. Avania delivered high-quality statistical services throughout the study and PMA process. We are very appreciative of their valuable statistical insights.”

Burke T. Barrett
Vice President of Regulatory & Clinical Affairs at CardioFocus

“While collaborating with Avania to prepare our mutual client for a successful FDA PMA Panel meeting, I was able to see first hand the quality of Avania. I have thoroughly enjoyed working with the Avania team. They provide an unparalleled level of dedication and service to their clients.”

Jim Dibiasi
3D Communications, LLC

“Avania understands the benefits of the Bayesian adaptive approach to clinical trial design. While partnering with Avania to provide adaptive clinical trial designs, I have seen how Avania provides thoughtful and aggressive strategic advice to its clients. Avania is dedicated to helping its clients using innovative and accurate statistical designs and analysis plans in line with current FDA guidance and the FDA’s critical path initiative.”

Jason Connor, Ph.D.
Statistical Scientist