How to use this case study
This simplified example follows a pre-filled autoinjector as one therapeutic system. Ask whether dose, formulation, container, delivery mechanism, user interaction and production controls support the same clinical use across organisational boundaries.
Case at a glance
A single-dose pre-filled autoinjector delivers a fixed volume of a biological medicinal product subcutaneously. An adult patient or carer removes the cap, places the device against the skin and initiates delivery. The device provides start and completion feedback and shields the needle after use.
Therapeutic value
Reliable self-administration of the prescribed medicinal product outside the clinic.
Combination boundary
Drug formulation, primary container, delivery device, labelling, packaging and user workflow.
Principal uncertainty
Whether drug and device interactions remain acceptable through shelf life and use.
Organisational challenge
Evidence is created by pharmaceutical, device, supplier, clinical and manufacturing teams.
Define the therapy and delivery claim together
The product is intended for single subcutaneous administration of a specified fixed dose of the medicinal product by adult patients or carers following prescription and training. It is supplied pre-filled for use in the stated population and use environment.
The dose, viscosity, injection time, population, body site, storage, preparation and user determine both pharmaceutical and device requirements. Apply MTL-102 — Intended Purpose, Users and Use Environments.
Draw one combination-product boundary
Translate therapy into device requirements
- The system shall deliver the specified dose volume within the approved time and accuracy limits across claimed conditions.
- The device shall accommodate the approved container and formulation properties throughout shelf life.
- Activation shall not occur before correct placement under foreseeable handling.
- Completion feedback shall correspond to the defined delivery state and shall not overstate delivery into the body.
- The needle shall remain protected before use and become shielded after withdrawal.
- Storage excursion, visible damage or expired product shall be identifiable and handled by clear instructions.
- Critical drug, container and device configurations shall be uniquely controlled and traceable.
Analyse treatment failure across constituents
Under-delivery
Viscosity, force, obstruction, early removal or mechanism failure reduces delivered volume. Control design margins, feedback and instructions.
Degraded medicine
Material interaction, temperature or agitation affects product quality. Control compatibility, storage, transport and shelf life.
Needlestick
Premature exposure or failed shielding injures a user. Use passive protective design and representative verification.
Use error
The patient misinterprets preparation or completion. Simplify the interface and validate critical tasks.
A single risk analysis must connect device failure and use error to therapeutic consequence. Apply MTL-114 — Medical-device Risk Management.
Assign ownership without fragmenting the product
A combination governance team owns the integrated intended purpose, risk position, configuration, evidence plan and change assessment. Pharmaceutical teams lead formulation and drug-product evidence; device teams lead mechanism and delivery performance; human-factors teams lead the user interface; manufacturing and supplier teams control the realised combination. Interface agreements define inputs, outputs, approval and escalation.
Systems engineering provides the integrating logic using MTL-105 — Systems Engineering, Architecture and Interfaces.
Build evidence around the final combination
Medicinal-product quality
Identity, strength, purity, stability, particles, container closure and handling.
Delivery performance
Dose accuracy, injection time, activation, forces, feedback, needle safety and robustness.
Compatibility
Dimensions, materials, silicone, break-loose and glide forces, viscosity, ageing and transport.
Human factors and clinical use
Critical tasks, training, comprehension, simulated use and relevance to clinical evidence.
Representative evidence should reflect the final formulation, container, device and instructions. See MTL-315 — ISO 11608 Needle-based Injection Systems.
Follow one dose-delivery thread
Release the exact combination
Transfer covers drug-product batch, container components, device parts, assembly, labelling, packaging, in-process controls and final acceptance. Release documentation links the approved constituent versions and confirms that production evidence represents the same combination used in verification, validation and stability studies.
Use a formulation change to test lifecycle control
A higher-concentration formulation reduces injection volume but increases viscosity. The team must reassess container compatibility, delivery force and time, dose accuracy, device margins, user feedback, stability, manufacturing, human factors, clinical evidence and regulatory strategy. Reusing the same device platform does not make the new combination unchanged.
Every constituent change requires an integrated impact assessment against the approved treatment-delivery argument.
Questions to challenge the case
- Who owns the integrated combination-product risk position?
- Which drug properties become device design inputs?
- What does completion feedback actually prove?
- Which evidence must use the final aged combination?
- How are supplier and constituent changes assessed together?
- What configuration identifies the product tested and released?