man running and rendered view of his lungs

Other Expertise

Avania’s experience spans the full spectrum of MedTech innovation.

While our core focus areas represent the largest share of our portfolio, our teams have also advanced countless other technologies across trauma, ophthalmology, respiratory care, women’s health, nephrology, and beyond. What unites every engagement is our MedTech-focused approach: customized systems, right-fit teams, and proven expertise guiding sponsors from early feasibility through pivotal and post-market programs. Wherever your device fits, Avania provides the knowledge, structure, and flexibility to bring it to life.

Connect with Our Medical Device Experts

Scientist Working in The Lab, Using Computer

Navigating the Unique Challenges of

Medical Device Development

Every therapeutic area carries its own operational and regulatory complexity. Whether managing trauma programs with emergency enrollment protocols, imaging-driven ophthalmic trials, or device-based women’s health interventions, Avania applies the same principles of precision, adaptability, and compliance that define our work across all MedTech sectors.

Across each domain, Avania combines specialist insight with operational discipline to deliver efficient, compliant, and scalable study execution.

Trauma

Partnerships with over 150 Level 1 trauma centers worldwide. Experienced in Exception from Informed Consent (EFIC) and equivalent global frameworks. Managed one of the largest trauma studies ever completed, activating 92 sites and enrolling nearly 1,400 patients between 2023 and 2024.

Ophthalmology

Conducted 15+ studies spanning AMD, glaucoma, dry eye, diabetic retinopathy, and retinal detachment across the U.S., Europe, Canada, and Australia. Experience in both regulatory-only and full-service study models, managing cohorts from 10 to 300 participants.

Women’s Health

Supported programs across endometrial ablation, IVF and infertility, pelvic organ prolapse, and contraceptive devices. Trials ranging from feasibility to post-market, typically enrolling 30–150 participants across North America and Europe.

Respiratory

Managed device programs for sleep apnea (PAP, CPAP, and ASV systems), nebulizers and inhalers, and lung ablation devices (RFA, MWA, cryoablation). Notable collaborations include Resvent, Onera, and Ony Biotech, with additional case studies under review.

Nephrology

Supported chronic kidney and end-stage renal disease programs, including Quanta Dialysis for home hemodialysis solutions.

Medical/Surgical

Provided regulatory and clinical operations support for a wide range of general surgical and medical technologies, always through a MedTech-focused lens.

Unparalleled Expertise: The Avania Team Advantage

Our clients value Avania’s ability to mobilize the right experts for every challenge. With global reach and therapeutic diversity, we place the appropriate medical and clinical SMEs based on the specific indication, ensuring informed oversight from startup through post-market follow-up.

Deep Therapeutic & Industry Insight

Avania’s multidisciplinary teams are steeped in the clinical, regulatory, and procedural nuances that shape device success. Our leaders bring direct experience from medical practice, industry R&D, and regulatory review — translating that knowledge into actionable strategy for sponsors worldwide.

Consistent, Dedicated & Flexible Teams

Low turnover and a collaborative culture mean continuity across long programs. Sponsors describe Avania as an extension of their in-house teams: professional, transparent, and agile in responding to evolving study needs.

Integrated Solutions for MedTech Innovation

Our full-lifecycle approach is the same across every therapeutic area: integrated regulatory, clinical, and operational excellence supporting the full product lifecycle.

reading and writing on business meeting notes

Strategic Consulting & Regulatory Pathways

Avania’s regulatory experts work across all major device categories and maintain active relationships with global agencies including the U.S. FDA, Australian TGA, Health Canada, and EU authorities under MDR/IVDR.

We bring direct experience interacting with specialized FDA divisions such as:

OHT1: Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
OHT3: Gastrorenal, OB/GYN, General Hospital, and Urology Devices
OHT4: Surgical and Infection Control Devices
OHT5: Neurological and Physical Medicine Devices

Explore our strategic advisory services

Clinical Development & Execution

Avania delivers flexible study management solutions to fit the scope,
risk, and regional footprint of each program. Our services include:

Global site activation, monitoring, and data management
Imaging and core lab coordination
Safety oversight and adjudication
Statistical analysis and regulatory reporting
Feasibility through post-market follow-up studies

Explore our strategic clinical development capabilities

Doctor, support and applause in celebration for team unity

Demonstrated Success Across

Therapeutic Areas

Avania’s expertise is proven across hundreds of diverse device programs,
from early-stage innovation to market expansion.

Each success reflects Avania’s ability to adapt our processes to fit the technology, indication, and region, delivering the same operational excellence that defines our work in every major therapeutic area.

View All Success Stories

“With over 15 years in trauma research at the site level, I’ve worked with many organizations — but Avania stands out. Their ability to dig deep into the therapeutic area of trauma and truly understand the nuances of EFIC studies is exceptional. They don’t just deliver; they support both clients and sites with a level of care and expertise that’s rare in this industry. Avania is a partner I trust to navigate complex clinical landscapes and consistently elevate the quality of research.”
Jeanette Podbielski
Clinical research lead at The University of Texas Health Science Center at Houston

“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.”
Dr. Paul Komenda, MD, MHA, FRCPC, FASN
Chief Medical Officer, Quanta Dialysis Technologies Limited

Trauma

Delivering One of the Largest Global Trauma Studies Through EFIC Navigation

Device:

Non-activated 4-factor prothrombin complex concentrate (4F-PCC)

Solution:

Avania was enlisted to support the sponsor in the site and country qualification and selection activity, and managed the site level regulatory submissions and processing

Problem:

Multi-national program in trauma research requiring exemption from informed consent (EFIC) or equivalent regulatory approvals

Outcome:

By the time the trial ended it had already enrolled just under 1,400 patients enrolled and 140 sites activated, making it one of the largest studies of trauma patients ever completed

Trauma

Accelerating First-in-Human Progress with Rapid EFIC Site Activation

Device:

Novel technology to treat major abdominal bleeding due to trauma

Solution:

Avania was able to support the addition of a new site, which navigated the regulatory approvals and contracting quickly in partnership with the sponsor

Problem:

Sponsor was finding it difficult to enroll in an EFIC environment at the sites that were activated

Outcome:

The first patient was successfully treated at the newly onboarded site, progressing the sponsor along a significant milestone in the FIH program

Ophthalmology

Enabling Phase 3 Advancement for Novel MGD and CLD Therapy

Device:

A pharmacological ointment to treat Meibomian Gland Dysfunction (MGD) and Contact Lens Discomfort (CLD)

Solution:

Avania identified clinics in Australia and New Zealand that could quickly enroll patients meeting the inclusion criteria, while also providing a comprehensive and thorough data package via EDC

Problem:

Client had multiple use cases moving to Phase 2 research in parallel

Outcome:

Avania supported successful statistical analyses that allowed the company to progress to Phase 3 studies and focus in on future research and marketing efforts

Women’s Health

Securing a 510(k) Pathway by Reducing Burdensome Testing Requirements

Device:

Novel pessary for management of urinary stress incontinence

Solution:

Avania provided strategic guidance and hands on support for bench testing, cleaning validation, microbial and TSS testing, and biocompatibility testing, and was able to argue against the requirement for clinical testing in interactive review meetings with the FDA

Problem:

Client had been advised that their 510(K) pathway would require clinical data as well as burdensome polar and non-polar E&L testing

Outcome:

FDA Class II 510(k) approval

Women’s Health

Orchestrating a Hybrid Partnership to Achieve On-Time PMA Approval

Device:

Endometrial Ablation System intended to treat menorrhagia

Solution:

Avania worked closely with the sponsor leads in the planning phase to design a program and project team that was right sized to fill into the services required

Problem:

The sponsor required a hybrid outsourcing solution, with shared site management and fully outsourced data solutions

Outcome:

Avania and the sponsor collaborated on a successful study execution on-time and in-budget that ultimately resulted in FDA PMA approval

Respiratory

Expediting Multi-Indication Enrollment for a Post-Market Lung Ablation Program

Device:

Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue

Solution:

Avania partnered with the sponsor to identify KOL physicians and sites for inclusion in the studies, and navigated multi-regional regulatory submissions to move towards enrollment in an expedited fashion

Problem:

Client was seeking to enroll multiple post market studies in parallel to test hypotheses across expanding indications

Outcome:

Trials are actively enrolling on schedule, with data readout anticipated ahead of major conferences which was a primary goal of the sponsor

Medical/Surgical

Advancing ICU Decision-Support Technology Through High-Quality Data Collection and Publication

Device:

Non-invasive hemodynamic monitoring system that measures cardiac output and assesses fluid responsiveness in patients

Solution:

Avania proposed a least burdensome approach to data collection for the site staff via an EDC logbook; Avania received iterative feedback from lead coordinators to ensure a comprehensive and efficient data collection process at sites

Problem:

Critical ICU data collection effort

Outcome:

Avania supported the conduct of the study and clinical data analysis which resulted in publications across three major journal outlets; sponsor ultimately leveraged data in a sale to a large strategic medical device manufacturer

Nephrology

Case Study: Quanta

Device:

Home hemodialysis (HHD) in patients with end-stage kidney disease (ESKD)

Solution:

Avania presented a well designed workflow for optimized patient and coordinator data entry in the EDC; managed several touch point calls with the site study coordinators around in-home use escalations and mitigations

Problem:

In home dialysis treatments and data collection presented several challenges

Outcome:

The product received FDA 510(k) approval on the heels of a successful collaboration across Avania and Quanta, which included a comprehensive study report and regulatory submission strategy

Partner with Avania’s

Experts Today

No matter how specialized or emerging your therapeutic area, Avania provides the structure, strategy, and expertise to advance your innovation efficiently and compliantly. From trauma and respiratory care to women’s health and nephrology, we bring the same proven approach that drives success across MedTech’s most complex categories.

Speak with Our Experts Request a Proposal