Medical Device Product Development Life Cycle

Medical Device Product Development Life Cycle

Initiation Oppurtunity and Concept Phase
• Look at the market potential
• By creating the product are we going to benefit as a company
• Market Size
• Market Competitors
• Key Partners
• Intellectual Property
• Here we define the product, look for the funding options
• Potential possibilities for marketing the product
Planning Stage
• Collect the user needs
• Translating of those needs into technical requirements and conceptualizng
how the device will look
For instance, Solidworks drawings
• Technical people start building the prototypes, building a design file and
broadening the scope to market the device
• Device is classified based on the risk associated with the device
Design and Development Phase: Planning

• Once the concept is proven to work-Design and Development activity for a

commercial product begins
• Engineers will iterate on the product design, get user feedback, do design
verification and validation, and start drafting technical documentation here
• Something like a blueprint of the device based on the customers
requirements
Design and Development Phase: Production
Processes
• During the design and development process stage the medical device and
the processes for its manufacturing are designed and tested until ready to
be transferred to production stage
• At this point the product has been submitted for Regulatory Approval
• In reality, the design and development process is iterative
• As design issues are identified and fixed, the design is improved and
optimized and tests may have to be repeated or specifications adjusted
until all relevant requirements are met
Product Launch

• Once a medical device firm gets clearance to commercialise a medical

device, the product enters the launch phase of its life cycle
• The product will be offered to hospitals, clinics, and healthcare
practitioners, with the maker providing training and assistance to ensure
that the equipment is used effectively
Post Market Phase
• Before a product is released onto the market, it is subjected to post-market
monitoring to ensure that it is safe for the general public
• Post market surveillance activities will be conducted to ensure that
adverse events that involve the medical device are reported,
• Clinical follow-up studies may be conducted and the manufacturer can still
address complaints or adverse events and make improvements to the
products.
• If the product proves to be a success, it may be launched into newer
markets