Our 22nd Year of Publication
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Cover Story

Medical Device Manufacturing : Balancing Innovation, Quality And Compliance

Globally, medical device industry is highly dynamic as new medical devices are developed, technologies improved, regulations changed and treatments are adopted worldwide. The industry has always been dependent upon product innovation to drive growth. The common challenge is how medical device manufacturers and their suppliers can simultaneously improve their financial performance, product innovation and quality while growing at a significants speed.

As per recent research report by “Cambashi” with a title “Beyond Trade-Offs: How Medical Device Manufacturers Can Balance Innovation, Quality and Compliance While Improving Profit”, the top opportunities for future improvements are:

  • New products and new product lines

  • Faster new product introduction

  • Product development efficiency

  • Additions to existing product lines

  • Lowering cost of quality

  • Improving product quality

The top four factors that companies expect will improve their success are product design, development and introduction: next two factors related to product quality.

It was found that about 25% of the companies who responded grew and made major improvements in business performance. They focus on what customers care about, they innovate aggressively and they improve at the operational level in manufacturing, planning and development. They implement measurement, production and management processes and a wide array of information systems.

These Companies achieve these major gains in quality and timeliness by improving metrics that are closer to the Quality by Design (QbD) concept. That concept is : quality is inherent to the product design and the production process, not necessarily achieved through additional steps or checks. This is often measured as process capability. Those with a more capable process are able to handle change and variety far more successfully than others.

In addition to having a well- designed product and process, process quality refers to the execution reliability of the process. So quality by execution is just as important as quality by design.

With that level of process understanding and capability, QbD is also designed to allow companies to make changes confidently without re-validating the processes.

By improving professional performance they create a stable environment built to accommodate change. Their continued improvements in their business performance also allow them to invest in education, information systems and better approaches throughout their business and their suppliers.

Indian medical device industry has enormous promise but is relatively much more immature in most of such business practices. In this issue as well as the next one, we highlight some of the areas of advancement and improvements in manufacturing practices for the benefit of our readers.

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