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. |