5 Phases of The Medical Device Development Lifecycle

In the medical device industry, introducing a new product to the market is significantly more complicated than in any other. It entails the diligent efforts of an experienced team of professionals who can efficiently manage the product development lifecycle.

A well-managed product development lifecycle will be a determining factor in the product’s time to market and overall profitability.

1. Conception and Planning

Planning begins with a conception process that leads to a working base for developing a medical device with benefits for users, a feasible production process, and regulatory compliance. In the following stages, prototypes will be developed, regulatory strategy will be developed, risk analysis will be performed, design files will be constructed, and a marketing plan will be drafted.

2. Design & Development

The design and development stage of the medical device life cycle include four components: New Process Development, Process Flow Diagram, Design for Manufacturing, and Pre-Process Failure Mode Effect Analysis. By following these steps, you will achieve low production times, production line optimization, cost-effective production, and regulatory compliance for your operation. It also drastically speeds up transitioning from the design to the mass manufacturing phase.

New Process Development (NPD)

Medical device product design should be carried out with manufacturing in mind. From the early stages of device components design, design input 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 Process Flow Diagram (PFD) is developed to layout and describe in detail all of the medical device assembly steps. This helps identify critical processes and preemptively avoid issues when dealing with regulatory bodies down the line.

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.

PFMEA

Pre-Process Failure Mode Effect Analysis (Pre-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.

3. Technology Transfer & New Product Introduction (NPI)

In the context of the 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:

• Establishing a shared language that facilitates effective communication and troubleshooting.
• Identifying potential failure points and preventing them from occurring in production to ensure a smooth transition to production.
• Production line verification and validation (PVV), process validation, testing and documenting the capability for manufacturing the product as specified.
• Optimizing the supply chain for consistent delivery times and competitive purchase costs for every medical device BOM item.

4. Mass Manufacturing of a Medical Device Product

With high-yield mass manufacturing poses many challenges 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 manufacturing team receives feedback and proceeds with optimizing and improving upon the production processes, to resolve any issues and produce an improved product. Information considered 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 the product launches, it will be used to help patients in 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.

5. Launch and Post Market

Upon gaining authorization to commercially distribute a medical device, the product will enter the launching stage of its life cycle.

For medical device manufacturers to guarantee timely delivery, remain within budget, and above all ensure the safe distribution of top-notch medical devices, it’s essential that they maintain a production plan and verify it meets regulatory requirements.

Manufacturers must stay closely connected to healthcare professionals, hospitals, and medical centers who acquire their device for providing the necessary training, guidance, and support to improve product efficiency. Additionally, collecting data from these users and evaluating them on a regular basis as part of a comprehensive risk management plan.

These activities are specifically needed when incorporating Post-Market Clinical Follow-Up (PMCF) and Post-Market Surveillance (PMS) that EU Medical Device Regulations (MDR) mandate.

How Quasar Can Help

Bringing a medical device from concept to reality is no small feat. It takes a meticulously planned out process along with countless technical files, regulations, and details that must be managed to make it all happen.

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 product to market.