Our Capabilities

Injectable Drug Delivery Devices Concept and Feasibility

DALIMED defines the injection device concept that best fits the drug product, target patients, healthcare professionals, and intended use environment.
We translate early product requirements into a user-centered device design that can move forward with confidence.

Concept Creation and Selection

We apply creative thinking to generate several distinct device concepts, then narrow them to the leading options for prototyping, in parallel with FTO analysis and patent strategy.

User, Therapy, and Use-Environment Definition

We map the drug type, indication, dosing regimen, user profile, and use environment, including home, clinic, or hospital use - to define clear usability, safety, ergonomic, and performance requirements.

Prototyping and Early Device Evaluation

We use a variety of prototyping methods such as rapid 3D printing, CNC machining, and silicone molding to iterate quickly and conduct early evaluation with representative users and technical stakeholders.

Device Compatibility and Configuration

We assess critical compatibility factors and route of administration (subcutaneous or intramuscular), including viscosity, pH, lyophilization requirements, dose volume, syringe or primary container type, needle gauge and material compatibility.

Development Path Planning

We define the preferred device strategy, regulatory path, intellectual property considerations, high-level timeline, technical milestones, and go / no-go criteria.

Injectable Device Customization

Many injectable drug programs are best served by adapting an existing device technology rather than developing a completely new solution from the ground up. DALIMED customizes injectable drug delivery technologies to fit the specific drug product, primary container, administration route, intended users, and other requirements. This approach can provide a clinically and commercially fit solution while reducing the risk, cost, and timeline associated with full new device development.

Concept Creation and Selection

We apply creative thinking to generate several distinct device concepts, then narrow them to the leading options for prototyping, in parallel with FTO analysis and patent strategy.

User, Therapy, and Use-Environment Definition

We map the drug type, indication, dosing regimen, user profile, and use environment, including home, clinic, or hospital use - to define clear usability, safety, ergonomic, and performance requirements.

Prototyping and Early Device Evaluation

We use a variety of prototyping methods such as rapid 3D printing, CNC machining, and silicone molding to iterate quickly and conduct early evaluation with representative users and technical stakeholders.

Device Compatibility and Configuration

We assess critical compatibility factors and route of administration (subcutaneous or intramuscular), including viscosity, pH, lyophilization requirements, dose volume, syringe or primary container type, needle gauge and material compatibility.

Development Path Planning

We define the preferred device strategy, regulatory path, intellectual property considerations, high-level timeline, technical milestones, and go / no-go criteria.

Injectable Device Development and Engineering

Once the device path and concept are defined, DALIMED moves into detailed design and engineering.
Our development know-how is supported by more than 20 years of experience in injectable drug delivery technologies and a wide portfolio of patented device solutions.
The goal is to create an injection device design that can be verified, validated, manufactured, supplied, and supported in regulatory submissions.

Detailed Device Design and Analysis

We convert user needs, clinical requirements, and product requirements into formal design inputs. Our structured development process includes raw material selection, finite element analysis, tolerance analysis, and engineering calculations.

Design for Manufacturing, Assembly, and Scale-Up

We work with suppliers, contract manufacturers, tooling partners, and equipment manufacturers to optimize design parts and assemblies for injection molding, scalable assembly, in-process inspection, and functional testing. This supports robust and reproducible performance from low-volume to high-volume commercial production.

Pilot Molding and Raw Materials

We use early pilot molding with medical-grade resins to verify design feasibility, mechanical performance, material behavior, and small-scale production capacities.

Process Development and Technology Transfer

Operations, engineering, and R&D work together to define molds, jigs, assembly equipment, inspection processes, and production methods. When needed, we coordinate with external partners to support process development and technology transfer.

Quality Assurance

Our quality assurance approach maintains the Design Master Record (DMR) and Design History File (DHF) and ensures that development and manufacturing activities are documented, traceable and compliant with all required standards and guidelines.

Lab Testing and Verification

Early and often laboratory testing confirms functionality, usability-related performance, and durability in production processes and realistic handling conditions. Final validation and verification confirm that the device meets technical specifications and performance requirements, including injection force, delivery time, dose delivery, needle shielding, activation performance, shelf-life and long-term mechanical durability.

Human Factors Studies

We conduct formative and summative studies with representative user groups. These studies confirm that the device is safe, intuitive, and aligned with user needs in the intended use environment.

Regulatory Support for Injectable Devices

Regulatory considerations are integrated from the earliest design phases.
DALIMED aligns device design, testing, documentation, usability evidence, and manufacturing data with applicable regulatory requirements to support global submissions.

Strategic Regulatory Planning

We align the injection device regulatory strategy with the overall drug development plan. This supports early integration of device information, primary packaging and drug documentation, and usability evidence into a coherent submission strategy

Global Regulatory Pathways

We define regulatory pathways for drug-device combination products and standalone medical devices across key markets. Our experience supports US and EU regulatory routes, including NDA, ANDA, 510(k), MAA, CE marking, and related submission requirements.

Master Files and Documentation Access

We support efficient health authority review by maintaining FDA master access (MAF) file documentation with Letter of Access (LoA) where applicable, as well as equivalent device documentation packages and technical files for the EU and other international markets.

Technical Files and EU MDR Article 117 Support

We prepare technical documentation for integral drug-device combinations in accordance with EU MDR Article 117 requirements, including documentation needed to support a notified body opinion where required.

Injectable Device Manufacturing and Process Validation

A successful injectable drug delivery device must be manufacturable at the required quality, volume, and cost.
DALIMED develops and validates the manufacturing process so the product can move from development to commercial production at the right scale for each stage of the pharmaceutical program.

Critical Quality Attributes

We identify, evaluate, and control critical quality attributes (CQA) so that quality is built into the device and manufacturing process from the start and maintained throughout the product’s stages.

Tooling and Production Line Implementation

Tooling, assembly equipment, in-process controls, inspection methods, and production line layouts are developed and targeted to support consistent commercial supply.

Manufacturing Process Validation

Installation qualification, operational qualification, and performance qualification are executed on production lines within an ISO 13485 compliant environment. Documentation is prepared in a format suitable for regulatory review and submission support.

Supplier Qualification for Components and Processes

Component, packaging, tooling, molding, assembly, and sterilization suppliers are selected and qualified. Technical and quality, agreements, incoming inspection plans, specifications, and controls are defined for critical materials and processes.

Design Transfer to Commercial Manufacturing

The team that develops the injection device supports the transfer to manufacturing. This reduces handover risk and provides structured documentation and on-site support through engineering runs, process validation, and initial commercial production.

Injectable Device Supply and Support

DALIMED supports reliable supply of injectable drug delivery devices throughout the product lifecycle.
We help pharmaceutical companies plan for flexible production locations, supplier continuity, capacity growth, regulatory change management, and post-market performance monitoring.

Supply Chain Setup and Management

We establish and manage supply chains for injection devices, components, assemblies, packaging, and related manufacturing processes across relevant markets. The supply model is structured for continuity, quality control, and regulatory compliance.

Supplier Oversight and Backup Supply Options

Suppliers are qualified and monitored on an ongoing basis. Backup supplier options are defined as part of the long-term supply strategy.

Planned Commercial Scale-Up

Volume growth is addressed during device design and supply planning. Tooling, molding, assembly, sterilization, and packaging relevant capacities are considered early so commercial scale-up can be managed as a planned program milestone.

Change Management

Design updates, supplier changes, site additions, and process changes are coordinated with full regulatory and quality oversight. All changes are documented and kept compliant with FDA and EU MDR requirements.

Post-Market Surveillance and Device Improvement

Complaints, corrective actions and field feedback are managed in line with ISO 13485 and applicable post-market surveillance requirements. Findings are fed back into engineering, manufacturing, and supply processes to maintain device performance over time.

Injectable Drug Delivery Partner for Pharmaceutical Companies

DALIMED supports pharmaceutical companies across the full injectable drug delivery lifecycle: from early device concept and feasibility through platform customization, engineering, regulatory support, manufacturing validation, commercial supply, and post-market lifecycle management.
Whether the right path is an existing device, an customized one or a totally new one, DALIMED helps align the device with the drug product, the users, the regulatory pathway, the manufacturing process, and the long-term supply strategy.

End-to-End Injectable Drug Delivery Device Solutions