Combination product development is entering a new phase of complexity and opportunity.
MGS
Accelerated biologics growth and increasingly specialised therapies are reshaping expectations for drug delivery devices. Higher viscosity formulations, larger delivery volumes and increasingly diverse patient populations are creating demand for platforms that can adapt more efficiently across therapeutic, usability and commercialisation requirements. At the same time, pharmaceutical companies are balancing growing portfolio diversity with increasing pressure to improve manufacturing efficiency, supply chain resilience and speed-to-market.
As combination products become more complex, product performance, manufacturability and scalability must be achieved simultaneously. Yet these requirements are often evaluated separately and at different stages of development, limiting visibility into how design decisions will perform in high-volume manufacturing, automated assembly and real-world patient use.
When auto-injector designs transition into prototyping and high-volume production, these gaps in alignment emerge as operational constraints. Component geometry, material selection and assembly sequence complexity all influence how efficiently a device can be developed, validated and launched.
Platform-based auto-injectors emerged in part to address the growing complexities associated with development and scale-up. Their established device technologies and standardised development frameworks helped pharmaceutical companies reduce technical risk and accelerate commercialisation.
However, as drug delivery requirements continue to evolve, many platforms originally designed around standardised drug formulations and delivery profiles are being challenged to support increasingly diverse therapeutic and patient needs. Today, adaptable auto-injector platforms are helping to bridge the gap between evolving drug delivery requirements and the realities of scalable manufacturing.
Enabling more efficient commercialisation strategies
Adaptable auto-injector platforms help organisations support broader formulation, delivery and patient requirements without requiring bespoke device design and development for every therapy. By leveraging established platform technologies and configurable development frameworks, pharmaceutical companies can accelerate timelines, reduce technical risk and bring therapies to market more efficiently while maintaining greater manufacturing continuity across expanding portfolios.
However, commercialisation efficiency depends not only on platform strategy, but on how effectively devices are designed for manufacturability, assembly and scale. As devices move toward commercial production, early-stage design decisions increasingly influence moulding behaviour, automation feasibility, assembly efficiency and throughput. Approaches that evaluate these considerations earlier can help reduce downstream redesigns, simplify technology transfer and improve manufacturability as programs advance toward market readiness.
This makes earlier alignment between Design and Development, Tooling, Automation and Manufacturing increasingly important. Siloed development models that separate these functions slow decision making, increase design iterations, drive up costs and create operational challenges during commercialisation and scale-up.
Integrated development approaches help teams evaluate device performance, manufacturability and automation feasibility simultaneously rather than sequentially. Earlier production visibility can help reduce transfer complexity, simplify validation strategies and improve confidence as programs move toward clinical and commercial manufacturing.
These capabilities are becoming increasingly important as pharmaceutical manufacturers respond to evolving global regulatory expectations surrounding combination products, lifecycle management and supply chain continuity. Adaptable platforms designed with manufacturability in mind can also support future line extensions, evolving formulations and regional market adaptations more efficiently by maintaining a more consistent manufacturing foundation across platform variants.
Commercialisation-ready platform development
In response to the gaps that patients, clinicians and Pharma developers were experiencing with current auto-injector platforms and designs, MGS developed the A.i.r. Platform to support more efficient auto-injector commercialisation through adaptable platform technology and integrated end-to-end capabilities. The modular auto-injector platform accelerates combination product development while enabling customisation across drug, device, patient and brand requirements.
The A.i.r. Platform was developed using insights from 14 therapeutic areas within subcutaneous drug delivery. The insights uncovered key challenges with existing off-the-shelf solutions, including incomplete injections, activation issues, grip endurance, cap release and overall patient use. MGS’ team of Design & Development experts created a platform that could address these issues while supporting a broad range of viscosities, fill volumes and primary container configurations.
Rather than requiring fully custom device development programs for every new therapy brought to market, the A.i.r. Platform enables pharmaceutical companies to leverage a flexible core technology while tailoring configurable elements around look, feel and functionality. Designed with manufacturability, automation readiness and scalable assembly in mind, the platform can reduce development timelines by up to three years compared to bespoke devices.
Its configurable core technology enables customisation without requiring entirely new manufacturing setups or assembly strategies for each device variation. This allows for more consistent automation strategies and validation approaches across platform variants.
Accelerating development through hybrid tooling
The A.i.r. Platform was also developed leveraging innovative tooling strategies to assess performance during early-stage design while laying the foundation for full-scale production. To improve visibility into manufacturability and automation performance early in development, MGS leveraged hybrid tooling, which leverages aluminium and steel within a single prototype tool to rapidly manufacture functional moulded parts under production-relevant conditions prior to committing to full-scale tooling investments.
Moulded prototype devices can be delivered in as little as one month, enabling pharmaceutical companies to accelerate feasibility assessments, user evaluations and automation planning using production-representative components. Unlike 3D printed components, these injection moulded parts more accurately represent final dimensional behaviour, manufacturability and assembly performance, helping teams make more informed development decisions before advancing toward full-scale manufacturing.
Through technologies like hybrid tooling, MGS’ team created a platform that could reduce development timelines, improve manufacturing readiness and accelerate commercialisation across increasingly complex combination product portfolios. By aligning device Design and Development, Tooling, Automation and Manufacturing earlier in the process, Pharma innovators can reduce complexity, minimise development iterations, simplify scale-up and improve manufacturability while bringing new therapies to patients more efficiently.
Preparing the next generation of combination products
The pharmaceutical industry is approaching an inflection point in combination product development.
Therapeutic innovation is advancing faster than many traditional drug delivery development models were designed to support. As biologics continue evolving toward more complex formulations, increasingly specialised patient populations and accelerated commercialisation expectations, pharmaceutical companies are placing greater demands on auto-injector platforms to deliver adaptability, manufacturability and scalability.
This is changing the role of the auto-injector itself. Platforms are no longer evaluated solely on device functionality or usability, but on how effectively they can support evolving portfolio strategies, increasingly personalised treatment approaches and scalable global commercialisation without introducing unnecessary development complexity. This is becoming especially important as rare disease therapies and specialised patient populations create growing demand for adaptable drug delivery systems capable of supporting broader formulation requirements and customisable patient experiences.
Increasingly, the organisations best positioned for success will be those capable of aligning device development, automation and manufacturing strategy alongside therapeutic development from the outset. Traditional sequential development models can create late-stage redesigns, technology transfer challenges and delayed commercialisation readiness.