The work that’s required to transition from the conception stage to the mass manufacturing of a medical device product, is as important as it is challenging. Proper management of medical device product development lifecycle can make the difference in bringing medical device products to market quickly and effectively.
This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, refinement, and adaptation, to result in a workable base for developing a medical device that is effective to use, feasible to produce, and can achieve regulatory compliance.
New Process Development (NPD)
Medical device product design should be carried out with manufacturing in mind. From the early stages of device components design, factors such as practical manufacturing limitations, ease of components assembly, and cost-efficient processing, should be taken into account. An experienced contract manufacturer utilizes New Process Development (NPD) principles, that include several techniques necessary to achieve seamless transitioning from design to manufacturing phase.
Process Flow Diagram (PFD)
Following the initial design phase, a PFD is developed to layout and describe in detail all of the medical -device’s assembly steps. This helps identify critical processes and preemptively avoid issues down the line, saving you money.
Design for Manufacturing (DFM)
Design for Manufacturing (DFM) focuses on adapting, from an engineering perspective, the product, its components, and/or any elements associated with its assembly, to mass production capabilities and parameters. This enables an effective, fast and smooth production process.
Pre-Process Failure Mode Effect Analysis (Pre-PFMEA)
The PFMEA is an analytical tool used to identify and evaluate the potential failures of a process. Through a PFMEA analysis, it is possible to identify and prioritize risk factors throughout the medical device product development lifecycle. The identified risk factors are then addressed from the design phase, removing major barriers for proceeding to production.
Benefits of utilizing NPD principles
A properly designed & developed medical device product has been optimized and prepared for mass manufacturing. All aspects are geared towards a specific process methodology capable of achieving low production times, production line and workstations optimization, and overall production cost-effectiveness. It also drastically speeds up transitioning from the design to the mass manufacturing phase.
In the context of medical device product development lifecycle, the term technology transfer refers to effectively transferring all of the knowledge gained from the conception, design and development phases, to the mass production phase. Within this scope, the New Product Introduction (NPI) methodology is used, which aims to optimize the production process without compromising quality, by means of:
● Creating a shared language for all aspects of the process, which enables effective communication and troubleshooting
● Assisting in identifying potential points of failure and preemptively resolving them from the development process, ensuring a smooth transition to the production with a minimum of setbacks
● Production line verification and validation (PVV), testing and documenting the capability for manufacturing the medical device product as specified.
● Streamlining the supply chain for achieving both consistent delivery times, as well as competitive purchase cost for every BOM item of the medical device.
Undertaking high yield mass manufacturing of the medical device product developed, poses a lot of challenges in order to provide products on time, within budget, and most importantly with excellent quality of manufacture. This is achieved through continuous process improvement in a cycle in which the medical device manufacturing team receives feedback and proceeds with optimizing and improving upon the production processes, in order to resolve any issues and produce an improved product. Information taken into account can include outside sources such as feedback from the customer or their clients and inside sources such as feedback from the manufacturing plants’ Quality Assurance department.
Once a medical device product launches, it will be used to help patients in hospitals and even operating ER rooms, where every small detail plays a critical role. That’s why employing best practices for mass manufacturing and consistently providing products and spare parts on time and up to specification, is of paramount importance.
Choosing the right partner to develop and produce your medical device products, plays a critical role in how you bring your products to market and can make or break a medical device product’s success. Contact us to discover how Quasar’s 30-year experience, infrastructure, and know-how, can help you bring your medical device to market.
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