Our 22nd Year of Publication
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Cover Story

Development of Plastics Injection Molded Medical Device: A Systematic Approach is Key to Success

Mr. Nikhil Patel
Credence Management Corporation,
Vadodra, Gujarat

The Indian health care industry is taking great strides. In the last few decades, the industry has grown to the status of a leading sector in the country with a sizable base.


India is doing extremely good in plastic disposables and low end plastic injection moulded medical devices. Unfortunately, 80% of our high-end medical devices are imported from other countries; on other hand there is 60% of export of or indigenously produced medical devices, especially disposables medical.


This is due to lack of innovation, lack of systematic approach to the development, Absence of good product design capability, Limited Knowledge of Manufacturing and Quality Assurance, limited world class manufacturing facility to open market and unclear regulatory support.


There is clear need of applying systematic approach to the device development, what developed countries in US and Europe are following from design brief to validations to mass manufacturing of medical devices.

Following structured development practices will definitely change the scenario of India- at present not being good at development of high-end plastics medical devices.

Itís essential to take project through each step to have world class quality device with full functionality and long term reliability.

Medical-device development has become increasingly complex in recent years. The advent of new technology, stricter regulatory requirements, and the ever increasing role of reimbursement for successful commercialization require careful planning and strategy setting, coordinated decisions, and consistent, rigorous processes. The design and implementation of such processes often captured in development models and related standard-operating procedures have become key to commercially successful devices.

I have tried putting together outline of structured methodology for development of plastics injection moulded medical devices. It is giving an idea of each development stages like; Preparing Design Brief, Concept Development, Product design, DFM, DFMEA, Design verification and validation (DQ), Engineering Drawing, Proto tool development, Production Tooling design and development, Process development and validation (IQ,OQ,PQ), Product testing and validation, product approvals etc.


Product Definition, Conceptualisation & Design:

A development process starts from gathering customer voice, which is been captured in the document called Design brief that focus on exactly what needs to be achieved before any work starts on the development. Regulatory and salutatory requirements should be defined at the start of device development project.

Once the product requirements are defined, a review of the existing intellectual property within a specific market or pathology is also conducted, as well as an early stage technology risk assessment. Patent search is vital to avoid duplication of R&D work and hence prevent cost of duplication and assess novelty and patentability of own developments with a view of applying for a domestic or foreign intellectual property right.

Multiple concepts are generated for Functionality, Aesthetics and user requirements. A cross-functional, project-core team is selected, and a general project plan and timeline developed. Design plan is been created where the team leader is responsible for initiating and managing the Design History File, a record indicating that the device was developed as described in the approved design brief / design plan.

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