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Therapeutic Areas Endocrinology, Gastroenterology, and Urology

Endocrinology, Gastroenterology, and Urology

From advanced diabetes technologies to minimally invasive urologic and gastrointestinal devices, innovation in these therapeutic areas is transforming quality of life for millions of patients worldwide. The path from concept to commercialization, however, is rarely straightforward; each study demands deep understanding of anatomy, regulatory nuance, and procedural variability.

Connect with Our Endocrinology, Gastroenterology, and Urology Experts

Advancing Endocrinology, Gastroenterology, and Urology MedTech

Avania’s MedTech focus ensures precision across every stage of this process. Our global team combines regulatory, clinical, and operational expertise to guide complex devices from First-in-Human through pivotal and post-market programs, whether pursuing EU CE Mark or U.S. FDA De Novo, 510(k), or PMA approval.

By aligning every project with subject matter experts, strategic oversight, and flexible execution models, Avania helps sponsors de-risk development and accelerate timelines across three of MedTech’s most dynamic therapeutic frontiers.

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Navigating the Unique Challenges of

Endocrinology, Gastroenterology, and Urology Device Development

Each of these therapeutic areas presents unique technical and regulatory hurdles: from complex anatomy and imaging demands to evolving evidence requirements for long-term safety and effectiveness.

Avania provides the depth of experience and flexibility required to navigate these challenges successfully.

  • Endocrinology: Devices supporting continuous monitoring, automated insulin delivery, and non-pharma metabolic solutions require precision data, cybersecurity validation, and human factor design.
  • Gastroenterology: Endoscopic and robotic systems demand meticulous coordination between device engineers, clinicians, and imaging partners, balancing usability and safety across variable anatomy.
  • Urology: Trials for implantable or energy-based BPH, incontinence, or prostate cancer therapies must account for procedural learning curves and long-term functional outcomes.
  • MedTech-Only Expertise: Unlike generalist CROs, Avania’s workflows and oversight are optimized for device complexity, ensuring regulatory compliance, data integrity, and operational efficiency from start to finish.

Unparalleled Expertise:

Meet Our Endocrinology, Gastroenterology, and Urology MedTech Veterans

Deborah Bell

Executive Director, Urology SME

Deborah Bell, RGN, CCRA

  • Over 30 years of global experience in urological device innovation, including implantables, energy-based modalities, and combination therapies
  • Expertise across BPH, urinary incontinence, prostate cancer, and painful bladder conditions
  • Recognized leader in clinical training, procedural support, regulatory strategy, and publication development
Karin Andersson

SME Hepatology & Gastroenterology

Dr. Karin Andersson, MD, MPH

  • Practicing transplant hepatologist and gastroenterologist at Massachusetts General Hospital
  • Deep expertise in liver diseases, viral hepatitis, and autoimmune liver conditions
  • Provides safety oversight and clinical guidance for gastroenterology and hepatology programs
Zohair Ahmed

SME, Gastroenterology

Dr. Zohair Ahmed, MD

  • Practicing interventional gastroenterologist specializing in endoscopic bariatric therapies and metabolic device research
  • Advises Avania study teams on training, safety review, and clinical development strategy
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The Avania Team Advantage

Avania’s Endocrinology, Gastroenterology, and Urology programs are led by specialists with decades of experience in device development, regulatory strategy, and global clinical operations. Every project includes direct access to senior leadership and medical SMEs, ensuring clear communication, continuity, and informed decision-making.

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Deep Therapeutic & Industry Insight

Our teams have supported technologies spanning metabolic disease, interventional gastroenterology, and urology, bringing firsthand experience with Class I–III devices, combination products, and chronic disease solutions. Each SME brings both clinical and commercial insight, helping sponsors anticipate challenges and accelerate approvals.

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Consistent, Dedicated & Flexible Teams

Our low-turnover project teams provide the stability and insight needed for long-term programs. Clients describe Avania as an extension of their in-house teams: responsive, professional, and proactive in managing timelines, communication, and compliance across multi-site, multi-country studies.

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Integrated Solutions for Endocrinology, Gastroenterology, and Urology Innovation

Avania offers a comprehensive, multidisciplinary service model supporting every stage of the product lifecycle. Our teams integrate regulatory, engineering, and commercial expertise to deliver cohesive, efficient programs that maintain scientific and operational rigor.

Strategic Consulting & Regulatory Pathways

Our regulatory experts work directly with sponsors to define optimal development and submission strategies for complex device categories. We maintain deep experience collaborating with the OHT3: Office of Gastrorenal, Obstetrics/Gynecology, General Hospital, and Urology Devices, ensuring strategic alignment across regulatory divisions.

Whether planning an early feasibility study or managing a PMA submission, Avania helps sponsors navigate classification challenges, pre-sub interactions, and evolving evidence expectations.

Clinical Development & Execution

Avania’s clinical operations and project management teams bring proven expertise in designing and executing complex clinical trials across endocrinology, gastroenterology, and urology.

  • Customized training and SME support for site investigators
  • Integrated safety and data oversight
  • Endoscopic and robotic workflow coordination
  • Device-specific data management and statistical analysis
  • Flexible engagement models for FIH, pivotal, and post-market studies

Our Track Record

Demonstrated Success in Endocrinology, Gastroenterology, and Urology

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

Endocrinology

  • Type 1 and Type 2 diabetes management technologies
  • Continuous glucose monitoring (CGM) and automated insulin delivery (AID) systems
  • Smart pens and pumps for optimized insulin dosing
  • Non-pharma weight loss and metabolic health solutions

Gastroenterology

  • Endoscopy and robotic systems for minimally invasive intervention
  • AI-driven imaging and diagnostic solutions
  • Bariatric and GI devices improving metabolic and digestive function
  • Non-pharma weight management devices and combination approaches

Urology

  • Minimally invasive therapies for BPH and urinary incontinence (UI/SUI/MUI)
  • Implantable stents and sacral neuromodulation systems
  • Prostate cancer combination therapies integrating device, diagnostic, and biologic components

Client

Successes

Each collaboration reflects Avania’s ability to manage complex, interdisciplinary programs, balancing regulatory strategy, clinical design, and real-world data integration to accelerate approval and adoption.

With 900 MedTech projects, 500+ regulatory submissions, and 25+ Breakthrough Device designations supported worldwide, Avania offers unmatched experience delivering successful outcomes across these critical areas of MedTech.

“Working with Avania has been a consistently professional and rewarding experience. As a committee chair, I’ve seen firsthand how thoroughly prepared their team is — they come to the table with a deep understanding of the regulations and a clear commitment to doing things the right way. They take their role seriously, balancing scientific rigor with practical execution. The team is well-trained, thoughtful, and genuinely invested in the success of each study. It’s clear they care — not just about the data, but about the people and the outcomes. That level of dedication makes all the difference.”

Dr. Karin Andersson, MD, MPH
Gastroenterologist and Transplant Hepatologist at Massachusetts General Hospital

Case Study

Achieving PMA and CMS Success Through Strategic Regulatory Partnership

Device:

Implantable, automated device that pumps ascites from the abdomen into the bladder for elimination through urination

Solution:

Strong regulatory and strategic consulting support, intense BIMO audit preparation, and summarized high volume of output in SSR

Problem:

High volume of output and high scrutiny from the FDA (>40 fileable FDA interactions)

Outcome:

Successful clinical trial that resulted in PMA approval and no BIMO inspection findings. Additional NTAP submitted and approved, resulting in CMS approval with the help of Avania reimbursement services

Case Study

Accelerating Enrollment and Restoring Momentum in BPH Study Execution

Device:

Minimally invasive procedure and temporary device placement delivering rapid and effective relief from BPH symptoms

Solution:

Avania joined amidst site onboarding and enrollment challenges, and provided project team support in the roles of project management and site monitoring support; Avania drew upon experience in the BPH space to mitigate the start-up and enrollment challenges

Problem:

Sponsor opened a multi-site, randomized controlled, post market study across the US and UK, but quickly found that the study management required external support

Outcome:

Enrollment rates increased 40% under the oversight of Avania, with full enrollment closed on schedule and primary comparison data available in time for key milestones (i.e. conference presentations)

Case Study

Scaling Global Research Efficiency Across a Diabetes Portfolio

Company:

Multi-national device manufacturer with a portfolio of products dedicated to advancing diabetes care and management

Solution:

Avania has now worked with the company on over ten engagements, providing study specific, customized support while developing client specific templates to translate lessons learned and efficiencies from one project to the next

Problem:

The client required a partner to be able to service multiple projects across the EU and US in a flexible, scalable manner

Outcome:

Programmatic solutions that provide efficient, consistent, and repeatable processes to be leveraged across the company’s portfolio of research studies for diabetes management

Partner with Avania’s

Endocrinology, Gastroenterology, and Urology Experts Today

Innovation in these therapeutic areas demands precision, flexibility, and a partner with the expertise to navigate complex, evolving regulatory and clinical environments. Avania’s specialized teams combine scientific depth with operational excellence, helping you bring transformative technologies to patients faster and with confidence.

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