An End-to-End Contract Development and Research Organization (CDRO) partner for pharmaceutical companies, device innovators, and CDMOs, supporting drug-device combination products from concept and design through testing, regulatory approval, and commercialization.
From initial concept to market launch, we provide end-to-end solutions that maximize value while minimizing risk throughout your product journey.
Selecting the right delivery platform and maturing it from concept to a pharma-ready device.
Learn MoreAn audit-ready Design History File and risk management to ISO 14971.
Learn MoreIn-house ISO/ASTM device testing, ICH stability, and analytical services under one roof.
Learn MoreFormative and summative usability studies to IEC 62366-1 and FDA guidance.
Learn MoreRegulatory strategy and filing across FDA, Health Canada, and EU MDR, plus QMS set-up.
Learn MoreComplaint handling, post-market surveillance, and legacy DHF remediation.
Learn MoreFull industrial and mechanical design of delivery devices and their components — translating your target product profile and molecule constraints into a manufacturable, human-centered design.
Executed under design controls per 21 CFR 820.30 and ISO 13485 §7.3.
Bridging design and production so a validated design transfers cleanly into manufacturing — process development, assembly, and scale-up coordinated with your fill-finish and CMO/CDMO partners.
Aligned to FDA process validation guidance and ISO 11607 for sterile barrier packaging.
Positioning, value messaging, and go-to-market support to bring a combination product to the right customers and partners — informed by deep industry relationships and market insight.
Part of our Business Development practice, supporting North American, EU, and Asia-Pacific market entry.
Customized training that upskills client teams in the disciplines combination-product development demands — delivered by engineers who have led programs at Fortune 500 device and pharma companies.
Formats from single workshops to ongoing programs, grounded in FDA and ISO expectations.
Identifying, evaluating, and qualifying the CRO, CMO/CDMO, and supply-chain partners a program needs — then managing the interfaces so the right vendors are matched to your product, timeline, and budget.
Vendor selection and qualification aligned to your quality system requirements.
MedNEx Device LLC is a business facilitator for pharmaceutical companies, device innovators, and CDMOs, with a core focus on engineering services, product commercialization, and business development.
To become the go-to partner for drug-device combination product clients looking to expand their portfolio and market reach — providing one-stop-shop services across conceptualization, design and development, commercialization, and business development.
We are a value-adding, long-term strategic partner, committed to quality, innovation, efficiency, and commercial success.
Decades of combined experience in drug delivery device development
Navigate FDA, Health Canada, and EU requirements with confidence
Streamlined processes to get your products to market faster
Your success is our priority — we work as an extension of your team
We begin by understanding your product vision, market goals, and technical requirements.
Our experts craft a comprehensive development and regulatory strategy tailored to your needs.
We execute the development plan with rigorous engineering and quality standards.
Support your successful product launch and market entry with ongoing guidance.
MedNEx Device was founded to make drug-device combination products easy. Our team brings decades of combined experience from leadership and technical roles at Fortune 500 companies — including Pfizer, Baxter, Abbott, BD, Medtronic, and P&G — giving combination-product innovators a single, expert partner from concept through commercialization.
PhDs across polymer science, chemical, and biomedical engineering, backed by deep laboratory and quality expertise.
Leadership and technical roles at Pfizer, Baxter, Abbott, BD, Medtronic, and P&G.
Products taken through FDA clearance and launched worldwide, with multiple patented inventions.
Honored with awards from Fortune 500 companies and professional societies.
What the revised “Applying Human Factors and Usability Engineering to Medical Devices” guidance changes in practice — HF as a formal design input, cumulative-change evidence, and a proportional framework for what reaches your submission.
Read Article (PDF)
The regulation that replaced most of 21 CFR 820 on February 2, 2026 — how it incorporates ISO 13485:2016, what changed from the legacy QSR, and what the transition means for combination-product manufacturers.
Read Article (PDF)Partner with MedNEx Device and leverage our expertise to bring your product to market efficiently and successfully.
Ready to take the next step? Our team is here to answer your questions and help you explore how we can support your goals.
