Uncover Unmet User Needs
Identify gaps standard devices cannot meet and define custom strategies that align drug, patient, and market needs.
Our ethnographic research and market analysis uncover unmet needs, workflow barriers, and therapeutic opportunities. By aligning drug delivery systems with real-world user and market requirements, we set a foundation for innovation that resonates with patients, providers, and payers.
Services: Research & strategy, opportunity mapping, feasibility studies (engineering and preclinical), market assessment, & regulatory strategy
Tailor Devices for Every User
Create ergonomics, feedback, and labeling built for diverse populations to ensure confidence, safety, and correct use.
Our human factors team has tested various drug delivery device types in the market, providing unmatched insights into usability and typical challenges. Combined with our industrial design and preclinical expertise, we support development of your drug delivery system to create intuitive systems that reduce use errors, improve adoption, and differentiate your therapeutic.
Services: Human factors usability testing, industrial design, non-GLP preclinical studies, procedure design, and packaging or labeling design
Devices Aligned to Your Drug and User Needs
Develop prototypes and test-ready systems that fit complex formulations and dosing regimens.
Multidisciplinary engineering teams transform concepts into robust, manufacturable devices. With in-house labs, biosafety facilities, and rapid prototyping, we advance your delivery system through verification, risk assessment, and preclinical evaluation.
Services: Mechanical, electrical, and software engineering, technical data accuracy test method development and validation, preclinical studies, and design verification & validation.
Generate Evidence That Matches Your Claims
Design validation and clinical studies around your product claims to streamline submissions and avoid retrofitting data.
Our integrated CRO services deliver device-specific clinical trials aligned with FDA and EU expectations. A regulatory team led by professionals with 20+ years of experience in the medical device industry will guide your drug delivery product submission, while our safety reporting and quality teams ensure compliance at every step.
Services: Strategic quality and regulatory consulting, Submission execution, Clinical strategy & trial design, Design validation, HF validation, Physician training; and integrated evidence planning with value communication tools
Strengthen Value and Market Access
Demonstrate adherence and usability gains that support payer value stories, accelerate adoption, and sustain growth.
From ISO-certified cleanroom builds for clinical trials to scalable manufacturing and supply-chain transfer, we prepare your drug delivery device for market. Our commercialization and market access experts secure payer adoption, protect pricing, and drive long-term growth.
Services: Manufacturing solutions, HEOR, reimbursement strategy, due diligence for device partners, & sustaining engineering
Wearable Injector Redesign
Situation
A top-5 pharma company needed a wearable infusion pump redesigned for multi-day use. The challenge was to ensure patient comfort and correct dosing while preparing for large-scale manufacturing.
Successes
- Formative usability studies reduced user errors by more than 70%
- Delivered manufacturable design ready for automated assembly line transfer
- Supported regulatory submission strategy that led to smooth FDA clearance
- Enabled full commercial launch within 12 months
Services by Veranex
- Human factors and usability testing
- Mechanical and software engineering
- Design for manufacturability (DFM)
- Regulatory submission support
Connected Pen Injector
Situation
A global pharma innovator required a disposable pen add-on device that could capture dose data with a MEMS flow sensor and transmit results via Bluetooth to a mobile app.
Successes
- Developed functional prototypes through Phase 2 that enabled early investor validation
- Integrated flow-sensing system with high accuracy
- Delivered a connected platform aligned with mobile ecosystem requirements
- Handoff of design enabled client to achieve high-volume commercial build
Services by Veranex
- Systems engineering and integration
- Rapid prototyping and testing
- Connectivity and app development
- Manufacturing transfer
Inhalation Delivery System
Situation
A biotech client needed to advance a liquid-based inhalation device through Phase 1 to 5 trials with more than 100,000 units built for clinical supply. The challenge was to ensure reliability and manufacturability under accelerated timelines.
Successes
- Produced more than 100,000 units at Veranex’s PVD facility to meet trial demand
- Managed regulatory documentation with zero FDA submission questions
- Delivered validated and scalable design that transferred to commercial production
- Supported seamless transition into later-phase trials with consistent output
Services by Veranex
- Preclinical build and validation
- Regulatory submission preparation
- Manufacturing scale-up for trial supply
- Quality system support
Preclinical Validation of Catheter-Based Drug Delivery
Situation
A biotech innovator developing a minimally invasive hydrogel-based drug delivery system for atrial fibrillation needed to demonstrate safety and effectiveness before entering FDA Pre-IND discussions. Traditional treatments were either invasive or carried toxic side effects, so the client sought a partner with expertise in catheter-based delivery, large preclinical models, and regulatory preparation.
Successes
- Executed procedure simulation that established catheter-based delivery to the pericardial space, reducing off-target toxicity and avoiding open-heart surgery
- Conducted preclinical testing with fluoroscopy in a catheterization lab with large preclinical models that enabled rapid prototype refinement
- Delivered hands-on mentorship and technical guidance that accelerated unfamiliar regulatory and procedural steps
- Generated critical data and feedback from academic and clinical stakeholders to position the company for FDA Pre-IND discussions
- Accelerated development of a Class III device by leveraging regional medtech ecosystem partnerships alongside Veranex support
Services by Veranex
- Preclinical
