Global challenges such as navigating an increasingly complicated regulatory landscape, an overall global lack of manufacturing capacities, and high levels of geopolitical uncertainty only add to the challenge. Successfully getting a medical device to market requires an integrated strategy for design and manufacture, which manages risk at each stage of the development process. In this context, the right CDMO is more than a vendor – it should and can be a strategic enabler.

GLOBAL CAPACITY AND FLEXIBLE MANUFACTURING

One of the most critical assets in today’s medical device landscape is manufacturing capacity and a flexible global footprint. The surge in demand for GLP1s has led to a massive demand for manufacturing capacity from big pharma companies for the devices that deliver them. This in turn has created a shortage of capacity for other medical device companies. In particular, the need to produce smaller batches of devices for clinical trials is becoming increasingly difficult as the capabilities required in terms of agility often differ from those for high-volume production.

Uncertainty regarding the geopolitical situation also implies that medical device companies need to be prepared to be globally flexible. Having partners who offer suitable manufacturing capabilities in different parts of the world offers resilience as well as improved access to markets. With its worldwide geographical footprint, Sanner provides these capabilities and can fulfil diverse customer needs – from regional market launches to globally distributed product lines. Additionally, all manufacturing sites implement the same high-quality approaches and meet the latest global standards such as cGMP, ISO 13485, and ISO 9001.

CLINICAL MANUFACTURING – CRUCIAL FOR DEVICE COMMERCIALISATION

Clinical builds are critical to the success of a novel product. Device companies and their partners must be prepared to react quickly to new developments, clinical trial findings, or regulatory changes. And they must have suitable manufacturing systems in place to avoid long set-up delays, which might lead to commercial opportunities being missed.

By integrating clinical insights with technical expertise, Sanner helps transform designs into clinically validated solutions positioned for regulatory success and market acceptance. Dedicated experts identify and resolve design limitations that might impact clinical outcomes. This includes implementing targeted modifications to enhance device functionality, address performance gaps, and ensure compliance with evolving clinical requirements – whether preparing for pivotal trials or addressing post-market performance expectations. Cross-functional teams bridge the gap between innovative concepts and clinical reality. Through iterative prototyping and manufacturing simulations, Sanner creates designs that balance clinical effectiveness with production efficiency. This dual focus reduces trial risks while establishing robust processes for commercial-scale manufacturing.

MANAGING COMPLEXITY WITH INTEGRATED DESIGN AND MANUFACTURING

Successfully getting a medical device to market requires an integrated strategy for design and manufacture, which manages risk at each stage of the development process. This process must consider a wide range of factors, including clinical functionality, usability, manufacturability, cost-effectiveness, and regulatory requirements. When these considerations are addressed in silos – by different teams and at different times – it results in an inefficient process with costly redesigns, project delays, and elevated levels of technical risk.

Mapping this entire process out as a single program with an integrated team provides the foundation for a successful project. From early feasibility and human-centred design through to high-volume serial production, assembly, and packaging: each step of the process needs to feed seamlessly into the next. This is achieved by embedding capabilities such as Design for Manufacturing and Assembly (DfMA), Human Factors Engineering (HFE), and Regulatory Affairs (RA) into a development project right from the beginning. Early collaboration avoids late-stage surprises, which can derail timelines and compromise product viability. Hence, building long-term feasibility and scalability into the design itself, instead of adding them as an afterthought, is paramount.

With Design Centres in the high-tech hubs of Cambridge, UK, and North Carolina, US, Sanner has access to the highest level of design and development expertise, and the unique ability to transfer this into cutting-edge medical device manufacturing completely in-house to the manufacturing facilities on three continents.

ADVANCED AUTOMATION FOR QUALITY AND EFFICIENCY

Another aspect that is crucial for efficient industrial-scale manufacturing is automation – not just for speed and cost efficiency, but also for ensuring consistent quality. Automation should be suitably designed to meet the requirements of the devices and increases in complexity the more parts must be assembled. Increased repeatability and the reduction of human errors combined with a higher degree of in-process controls such as load cells or camera checks make the highest levels of quality assurance possible.

GLOBAL SUPPLY CHAINS AND REGULATORY COMPLIANCE

Supply chain disruption has become one of the defining challenges of the last years. From raw material shortages to transportation delays, these issues can have huge impacts on launch timelines and production continuity. For any global medical device supplier, it is vital to analyse the resilience of their manufacturing supply chains and put in place suitable mitigations to the biggest risks. Sanner has established a global injection moulding backup system for medical devices. Through a combination of multi-sourcing strategies, local supplier networks, and digital supply chain monitoring, the company offers both agility and security. In addition, the global footprint allows Sanner to shift production as needed to respond to changing conditions or customer requirements.

At the same time, regulatory compliance and navigating regulatory approval is a core part of any medical device project. Risk mitigation should be proactive, and regulators will expect to see a clear link between the customer requirements and design inputs from the development process through to the controls in place during manufacturing. If targeting multiple global markets, a coherent strategy is vital. Sanner has the expertise across Europe, North America, and China to support customers through ISO 13485 audits, prepare documentation for CE marking, or ensure FDA 21 CFR Part 820 compliance.

CASE STUDY

The SmartSite IV bag and the needle-free SmartSite valve connector, developed by Sanner’s US design and development team in close partnership with a key customer, is a good example for sustainable development (figure 4). The solution addresses the need for empty IV bags, predominantly in in-patient care. The needle-free valve effectively eliminates the risk of injury from needles when handling the bag, which is statistically one of the biggest sources of injuries in hospitals. The bags also offer a significant environmental advantage: thanks to their specific design, they can be filled with IV solution, hygienically disinfected, and refilled with new medication. This reduces single-use plastic waste considerably. Additionally, they are designed to collapse when emptying to minimize drug waste and save even more resources.

By combining world-class design expertise, global manufacturing capacity, regulatory insight, and operational excellence, Sanner helps its partners to not only navigate these challenges but to thrive within them. Whether launching a next-generation drug delivery combination device, an innovative diagnostic, or a connected health device, Sanner provides everything clients need from a single source. As healthcare continues to evolve, so too must the partnerships that drive it. With a foundation of quality and shared purpose, Sanner is ready to meet the future of medical device development together with its customers and partners.

“CDMOS as Strategic Enablers for Device Industrialisation” was originally created and published by Medical Device Network, a GlobalData owned brand.

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