Not Every CRO is Built for Innovation. Veranex is.
A new kind of partner that’s purpose-built to accelerate MedTech breakthroughs from sketch to market.
The Current CRO Model is Broken and Innovators Pay the Price
Medical device development shouldn’t require so many handoffs.
You design it here. You test it there. Then comes a regulatory consultant, a clinical team, a reimbursement strategist—each one a new exchange that costs time, burns capital, and adds risk.
However, your project doesn’t have to stall. Your budget doesn’t have to bleed. The traditional CRO wasn’t built for innovative collaboration, speed, complexity, or the full scope of modern MedTech development.
So, we built something else.

Discover the iCRO: The Innovation Contract Research Organization
As the industry’s first iCRO, Veranex offers more than a smarter workflow. We reimagined what it truly takes to bring breakthrough technologies to life—and integrated eight essential disciplines under one roof, built upon best-in-breed capabilities.
All connected. All aligned. All working to bring your innovation with evidence to market—faster, safer, smarter.
What You Gain with an iCRO
Save Time
- Integrated teams cut 3-6 mo. per phase*
- Manufacturing prep from design through pre / clinical
- First-time-right protocols & execution—best in industry
- Trim learning curves & enhance adoption via custom training
* When leveraging iCRO vs. traditional siloed outsourcing practices
Capital Efficiency
- Partnership models available
- Less rework = ↓ 18 % budget variance*
- 600 + AVL for scalable manufacturing
- Clearer investor narratives
* When compared to transactional outsourcing practices
De-Risked Decisions
- Secure market fit with design + reimbursement
- Regulatory consulting with 96% clearance rate*
- Integration of pre/clinical feedback into design
- Evidence planning strategy baked in
* Based on CV 510(k), PMA & De Novo approvals in CV
Case Studies
Sketch-to-Market — Minus the Chaos
One integrated iCRO team powers concept, evidence, and launch—no hand-offs, no surprises.
From Design Sprint to 510(k) in One Year
Situation
A cardiovascular team needed to reinvent a mechanical venous-thromboembolism (VTE) device—improving ease-of-use while re-using existing system accessories to keep costs down. They also wanted a straight-line path to clearance and commercial launch.
iCRO Impact
- Instead of juggling multiple vendors, the client tapped a single iCRO squad—spanning product design, human-factors, manufacturing, and regulatory. Together we:
- Ideated and prototyped a new handle, packaging, and kit layout.
- Ran formative usability testing with ICU and OR teams, then refined labeling to eliminate confusion. 84% reduction in user errors.
- Sourced and integrated system accessories, building a pilot line ready to scale. Built 1,000 + units for launch.
- Compiled a friction-free DHF and navigated the FDA submission playbook. Obtained 510(k) in 1 year from kickoff.
Services by Veranex
Early discovery | Rapid prototyping | Human-factors & usability testing | Product refinement | Manufacturing scale-up | Regulatory & quality strategy
From Insight Sprint to Point-of-Care Sepsis Test
Situation
Inflammatix set out to bring the TriVerity™ Acute Infection & Sepsis Test system—the Myrna™ instrument plus single-use TriVerity cartridge—from bench concept to point-of-care reality. They needed deep clinical insight, user-driven design, and a clear path to manufacturing and launch.
iCRO Impact
- Partnering with Veranex gave Inflammatix a single, cross-disciplinary team instead of multiple vendors. Together, we:
- Performed clinical observation and stakeholder interviews to map workflow pain points.
- Synthesized insights into opportunity maps that guided concept and industrial design of the instrument and cartridge.
- Conducted iterative usability validation with emergency-department and laboratory teams, refining form factor, labeling, and software UI.
- As we worked with the teams across Veranex, Inflammatix “always felt like partners, not clients.” — Paul Fink, VP of Engineering
Services by Veranex
Clinical immersion | Opportunity mapping | Concept & industrial design | Usability testing | Pilot-line manufacturing | Regulatory & reimbursement strategy
Meet the Team
The iCRO Brain Trust — Powering Breakthroughs
Cross-functional leaders who turn concept into clinic—guiding innovators and strategics toward patient-benefiting MedTech.
Lisa Boyle
Chief Innovation Officer
Lisa guides our Medical Device CRO team helping clients deliver the next generation of medical devices and in-vitro diagnostics. She has helped MedTech innovators bring to life scores of new medical devices and/or generational enhancements over her 15-plus year career.
Having worked on both sides of the innovator | CRO fence, especially in the coronary and structural heart domains, including senior roles with Medtronic, BD and JenaValve, she understands what innovators need and how to get there be they startups, growth stage companies or large strategics. JenaValve, a pioneer in transcatheter treatment of aortic regurgitation, was acquired by Edwards Life Sciences in 2024.
Lisa brings comprehensive expertise across business unit, corporate, and small business operations, with particular focus on real-world evidence, data analytics, and operational excellence; concept to commercialization and beyond.
Tom Lutzow
Vice President, Research & Design
Meeting an unmet clinical need starts with exceptional design. That’s why Tom Lutzow and his team focus on human factors evaluation, engineering, and testing that drive safer, more effective, and commercially viable solutions. Their work blends user insights with technical excellence—grounded in regulatory foresight and manufacturability—to reduce risk and accelerate development.
Tom has guided hundreds of innovators in shaping novel MedTech concepts into development-ready products. By embedding human-centered design into every phase—and collaborating closely with downstream functions like commercialization—his team ensures the right product gets to market, faster.
Joe Gordon
Vice President, Innovation and Technology
Based at our Providence, RI Innovation Center, Joe Gordon leads Veranex’s innovation engine—guiding early-stage concepts and generational enhancements into real-world solutions across more than 300 MedTech and in vitro diagnostic (IVD) projects. He specializes in translating ambiguity into actionable strategy, driving clarity through complexity, and aligning multidisciplinary teams to accelerate product realization. Whether it’s digital surgery platforms or wearable drug-delivery devices, Joe ensures each innovation is both breakthrough and buildable.
With over 20 years at the forefront of MedTech development, Joe plays a central role in full lifecycle programs—often leading from nascent idea through commercialization. He excels in navigating crowded patent landscapes and designing robust IP strategies that protect value creation. From capital systems to next-gen diagnostics, Joe’s diverse expertise and strategic foresight help set the innovation direction for clients aiming to reshape healthcare.
Nicolas Borenstein, DVM, MsC, PhD
Senior Vice President, Preclinical Services
Based in our state-of-the-art preclinical facilities in Paris, France, Nicolas Borenstein serves as co-president of preclinical services. He possesses extensive expertise in surgical and transcatheter preclinical science, particularly in cardiovascular medical devices. A widely published author and peer-reviewed journal reviewer, Nicolas combines academic excellence with hands-on surgical expertise. His work and leadership have contributed to hundreds of regulatory submissions for U.S., European and other global regulatory bodies covering the entire range of classifications or complexity from CE mark approvals and U.S. FDA 510ks to Class II and Class III PMA required devices. His additional qualifications include specialized certifications in microsurgery, experimental surgery, and animal research.
Morwan Choli, PhD
Senior Vice President, Global Regulatory Affairs and Quality
With more than 15 years of experience navigating complex regulatory environments worldwide and an expert in the field of MRI, Morwan Choli joined Veranex in May 2025 after serving as Executive Vice President of Global Regulatory Affairs and Quality and Managing Director of the German manufacturing site for Occlutech, a leading specialist provider of minimally invasive Class III cardiac devices. In this dual role, he led global registration strategies across more than 80 countries, directed quality systems for multiple production sites, and successfully secured the company’s first FDA Pre-Market Approval (PMA). His detailed, global knowledge of regulatory and quality environments for MedTech innovators and industry “strategics” is a high value asset accessible to Veranex clients at any stage in their commercialization pathway including post market surveillance, market expansion investigation or activities or next generation product development.
Joseph Ferrara
Chief Strategy Officer
Demonstrating value isn’t optional—it’s foundational. Whether you're seeking market authorization, payer access, or clinical adoption, your strategy must be evidence-driven from day one. For startups and growth-stage companies, this means aligning development with the expectations of clinical, regulatory, and economic stakeholders. For established players, it means meeting rising global demands for proof—and defending the value of innovation at scale.
Joe Ferrara brings over two decades of strategic leadership to innovators across medtech, diagnostics, and biopharma. His expertise spans pricing and reimbursement, health economics, market access, and growth strategy—with deep specialization in precision medicine, clinical diagnostics, and digital and AI-enabled technologies.
Veranex: Built for the Next Era of MedTech
We don’t just think across disciplines. We execute across them.
The only CRO capable of integrating design, preclinical, clinical, regulatory, and commercialization under one roof. Pair your passion for MedTech with our purpose, to deliver life-changing treatments to patients faster, safer, smarter. That’s the iCRO difference.
Product development programs
Preclinical & clinical projects
Cross-disciplinary experts
In enterprise fueled value
Turn Vision into Velocity
Veranex Is Your Engine
Partner with the iCRO to provide your team with the strategy, speed, and strength to bring breakthrough ideas into reality—without churn, chaos, or compromise. Need support at any stage of the journey? We’ve got you covered.



