What is industrialisation? 

Industrialisation is the systematic and strategic process of transforming a medical device concept or prototype into a fully realised, commercially viable product ready for mass production and market distribution. This involves a series of steps, including optimising the manufacturing process, ensuring regulatory compliance, managing supply chains, and establishing quality control measures. The industrialisation aspect of the product life cycle should be considered early to prevent delays and hiccups down the line. 

Understanding the role of compliance 

For medical devices, compliance is not just a buzzword – it’s the cornerstone of safety and efficacy. The stringent regulations and standards governing medical device development underscore the need for a compliance-centric approach. This emphasis on adherence to regulations guides companies toward building products that not only meet safety standards but also seamlessly integrate into the broader healthcare landscape. It also ensures that even a product that comes off the production line and onto the market is reliable and consistent. 

Pilotfish’s approach to compliance-driven industrialisation 

With ISO9001 and ISO 13485 certification, Pilotfish has experience in ensuring that every process and component aligns with the rigorous regulatory criteria while also optimising the industrialisation processes to meet business timelines and budgets. 

So, how do we do it? 

Parts and Subassemblies

We kick-start the industrialisation process by designing and producing parts and subassemblies tailored to your specific requirements. While we can create these components in-house, the final assembly integration can be handled either by your team or in collaboration with Pilotfish’s innovation management experts. 

Innovation Management 

Pilotfish provides innovation management support throughout the development process, with a strong focus on the mechanical parts, prototyping, testing, and comprehensive documentation. Documentation plays a vital role, and our experts ensure that everything is in order, from building the necessary tools to managing changes through Engineering Change Requests (ECR) and Engineering Change Notifications. We maintain a keen focus on the completeness and accuracy of technical dossiers, including Design Master Records (DMR). When any changes occur within the DMR, we meticulously process the associated documents, guaranteeing that all compliance-related paperwork is well-maintained. 

Versatility Across Different Classes 

Pilotfish caters to a wide range of medical device classes, and we recognize the distinct challenges and requirements that each class presents. Our team is well-equipped to navigate the intricacies of developing biocompatible parts, such as plastic and silicone components. 

Source from Certified Suppliers 

Taiwan boasts a burgeoning base of manufacturers that are ISO 13485 certified, making it an ideal hub for sourcing components and materials. We can assist in finding the right suppliers for specific materials, ensuring you have access to high-quality resources. Working exclusively with certified suppliers is a key element of our industrialization process so that we can seamlessly transition your product into the production phase. This collaborative effort ensures that your medical device is set for success in terms of compliance and quality.