Strategic Combination Product Planning
For a combination product, clarity on regulatory classification, development strategy, market opportunity, and business needs are all critical to saving years or significant costs and successfully getting to market.
Key Services & Deliverables:
- Regulatory pathway definition (drug-led, device-led, or co-developed)
- CE Mark regulatory strategy under EU MDR/IVDR
- Market and payer landscape assessment
- Early business case modeling and value proposition development
- User informed opportunity definitions to inform concept generations
- Integrated clinical, regulatory, and market strategy planning
Development Services for a Reliable Design
Our integrated teams with quality, engineering, manufacturing, and human factors de-risk your product throughout development to ensure the design is reliable, effective, and safe.
Key Services & Deliverables:
- Human-centered design for auto-injectors, inhalers, infusion systems, and implants
- Material compatibility testing to protect drug stability
- Industrial and digital design for packaging, labeling, and user interfaces
- Human factor engineers informing usable designs for successful formative and summative studies.
- Development of Instructions for Use (IFU) and training programs
- Controlled engineering or V&V builds
Clinical Strategy & Post-Market Surveillance
Clinical trials for combination products are more complex because they must address both drug performance and device usability. Careful trial design accelerates regulatory approval and payer acceptance.
Key Services & Deliverables:
- Clinical strategy integrating FDA and Notified Body expectations for drug-device studies
- Study designs aligned to ISO 14155 standards
- Safety reporting that includes pharmacovigilance and device vigilance
- Post-market surveillance strategies
Regulatory & Quality Consulting and Support
Our team works with drug sponsors to define the regulatory and quality strategy for the device component and continues collaborating with the device partner through submission and launch.
Key Services & Deliverables:
- QMS harmonization across ISO 13485 and US QMSR
- FDA submissions including IDE, PMA, 510(k), and De Novo
- EU pathway execution, including alignment with notified bodies through structured dialogue
- Integrated risk management under ISO 14971
- Preparation of design history files and technical documentation
- EU, Swiss, and UK Authorized Representative services for non-EU manufacturers
Drug-Eluting Ophthalmic Implant
Situation
An ophthalmology innovator required a combination implant that delivered sustained therapeutic effect while meeting MDR compliance.
Successes
- Developed an advanced intraocular lens with drug-eluting capability
- Conducted biocompatibility and sterilization validation testing
- Generated health economics and reimbursement models for payer adoption
- Delivered regulatory documentation for CE-mark under EU MDR
Services by Veranex
- Design and engineering
- Biocompatibility and sterilization testing
- Regulatory and quality strategy
- Market access and HEOR
Digitally Enabled Injection System
Situation
A client needed a digital-enabled combination device to track therapeutic delivery and improve therapy adherence.
Successes
- Developed MEMS-based flow sensor integrated into delivery platform
- Created digital interface for patient monitoring and adherence tracking
- Delivered validated usability testing and IFU development
- Supported regulatory submission with combined device–software documentation
Services by Veranex
- Digital design and UX development
- Human factors and usability
- Software engineering and validation
- Regulatory submission support
Hydrocephalus Shunt Redesign
Situation
A client needed to redesign an implantable hydrocephalus shunt that combined drug delivery with mechanical drainage for long-term patient safety.
Successes
- Conducted failure mode analysis and re-engineered shunt system
- Integrated material science expertise to improve durability and reduce complications
- Delivered validated design history file (DHF) for regulatory submission
- Supported post-launch optimization for improved clinical outcomes
Services by Veranex
- Design and engineering
- Material science analysis
- Verification and validation testing
- Regulatory documentation
