Drugs and medical devices belong to two sectors with different regulations and operational models, each governed by strict requirements.
The increasing complexity of regulations and the rise of therapies that combine a drug with a device call for a thorough rethinking of traditional development models.
PTM Consulting supports pharmaceutical companies and medical device manufacturers in the development of Combination Products, ensuring an integrated management of both design and regulatory activities.
PTM Consulting Expertise
With over twenty years of experience, PTM Consulting brings together pharmaceutical and medical device expertise in a structured way, with particular strengths in Device Development and associated Design Control, Quality by Design (QbD), and Risk Management (ISO 14971 and ICH Q9).
MDR
Title 21 CFR Part 4
Title 21 CFR 820
This dual expertise ensures rigorous compliance management with regulatory requirements such as the Medical Device Regulation (MDR 2017/745 for Europe), the Regulation of Combination Products (FDA, Title 21 CFR Part 4), and the Quality System Regulation (QSR, FDA 21 CFR 820).
It also reduces design risks, streamlines approval pathways and generates tangible value across the entire development lifecycle.
What Are Combination Products?
Combination Products are therapeutic solutions that integrate two distinct components, such as a drug and a medical device (e.g., prefilled syringes, auto-injectors, pressurized inhalers).
These complex products require an integrated approach across different company functions, where collaboration between technical, regulatory, quality, procurement and commercial teams is critical.
This integrated vision ensures:
Patient safety
Economic sustainability
Operational excellence
Product value
Combination Product Development: Key Challenges
Our experience highlights specific challenges that can compromise project success:
Organizational isolation of teams
Pharmaceutical development teams and device design teams often work in parallel, communicating only at later stages, generating design inconsistencies.
Terminology and cultural barriers
Differences in terminology between pharma and device sectors create misunderstandings that slow down development and increase the risk of non-compliance.
Integration of development processes
Lack of truly integrated processes hinders effective collaboration among development teams, leading to delays and inefficiencies.
Understanding the device role
Historically treated as packaging, the device component now requires management covering design, development and production in compliance with EU and US regulations.
Fragmented Compliance and Risk Management
Separate management of Risk Management processes (ICH Q9 vs ISO 14971) create redundancies, omissions or conflicts that only emerge at advanced development or registration stages.
Supplier management
Managing suppliers and external partners requires clear, shared processes and documentation to ensure the quality of the entire Combination Product.
PTM Consulting’s Integrated Approach
In the Combination Product sector, a structured approach is essential to integrate drug and device into a single development flow.
Strategic decisions—such as selecting target markets, designing a new device versus using an existing one, or defining the target population—directly impact technical and operational choices from the very beginning.
Often, these decisions are made late in the process, risking previously completed design activities and affecting timelines, costs, and compliance.
PTM Consulting has developed a comprehensive methodology that combines Quality by Design and Design Control, covering the entire product lifecycle—from initial development to post-market surveillance.
This approach optimizes not only market immission but the full lifecycle of the Combination Product.
01.
Quality by Design Applied to Combination Products
Definition of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) for drug-device combinations.
Integrated Design Space to anticipate design and production issues.
02.
Systematic and Integrated Risk Management
Single Risk Management framework combining ICH Q9 and ISO 14971, eliminating duplication and documentation gaps.
Shared, real-time updated risk register between Pharma and Device teams.
03.
Integrated Development (Pharma/Device)
Synchronization of technical activities (formulation, device-product compatibility, device usability) from device selection and Proof of Concept.
Stage-Gate planning and management to avoid information loss and delays in intermediate stages.
04.
Smooth Design Transfer
Structured transition from clinical development to commercial manufacturing, reducing delays and errors typical of late-stage processes.
PTM Consulting’s Approach Enables To
Ridurre i tempi di sviluppo e approvazione regolatoria
Optimize R&D investment, lowering overall project costs
Minimize non-compliance risks while increasing final product robustness
PTM Consulting Methodology
Our integrated methodology addresses all critical elements of the development process in a structured and systematic way.
Critical element |
PTM approach |
Advantage |
|---|---|---|
| User needs and user environment |
In-depth analysis of intended use and user context | Patient-centered products with improved compliance |
| Human Factors and Risk Management | HF evaluation from Risk Assessment through HF study planning | Design and usability with managed and mitigated risks |
| Design input | Clear and unambiguous definition of requirements | Systematic verification of all requirements |
| Essential Drug Delivery Outputs | Monitoring of critical parameters | Consistency and treatment effectiveness |
| Verification and Validation | Integrated, comprehensive, and traceable approach | Adherence to requirements and user needs: fit-for-use product |
| Design History File | Complete and structured documentation | Facilitated regulatory compliance |
| Supplier quality management | Qualification and monitoring strategies | Ensured quality of the final product |
| Platform approach | Strategies for product families | Optimized development |
| Post-market management | Leveraging acquired knowledge to manage changes and post-market surveillance | Continuous lifecycle management |
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