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Main Subject - Organisational Culture for Continuous Improvement
I have been working with leading Business Improvement guru, Tim Franklin, preparing the PR for his latest book which offers an i
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ntroduction to Continuous Improvement (CI) at beginner level, encompassing Lean, TQM, Six Sigma and the other related methodolog
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
es of CI.
He was developing an analogy of a geographic expedition to describe Continuous Improvement. As you start out on an ex
He was developing an analogy of a geographic expedition to describe Continuous Improvement. As you start out on an ex
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
edition, you can see the horizon clearly as being the final destination, but as you walk towards it, it recedes and eludes you,
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ike a moving target. CI is like this in practise. In the beginning you think that you know the maximum benefit that you can leve
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
from a particular process, but if you continue to revisit the same process time and time again, it’s amazing how your comprehen
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ion alters through experience – learning by doing.
Sadly, many organisations don’t develop this advanced comprehension, because
Sadly, many organisations don’t develop this advanced comprehension, because
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
they don’t embrace the ideology behind CI, they see TQM or Lean as a set of tools and techniques, rather than a different way o
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
working.
By simply imposing CI as an additional set of craft skills, employees can become suspicious, wondering just what the
By simply imposing CI as an additional set of craft skills, employees can become suspicious, wondering just what the
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
idden agenda may be. Just look up the word Lean in the dictionary – devoid of fat, sparse – no wonder that many employees think
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
hat it is another term for downsizing.
In Tim's view, to get the best from CI, you need to have an organisational culture that
In Tim's view, to get the best from CI, you need to have an organisational culture that
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
upports the ideology – empowerment, no blame for trying and failing, good leadership with modest egos.
Given the choice of
a)i
Given the choice of
a)i
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
posing CI;
b)modifying CI to suit the prevailing culture; or
c)changing the culture to suit CI guess which one most o
b)modifying CI to suit the prevailing culture; or
c)changing the culture to suit CI guess which one most o
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ganisations adopt?
Organisational culture can act as an invisible force to repel CI introduction. Being invisible, management c
Organisational culture can act as an invisible force to repel CI introduction. Being invisible, management c
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
an misinterpret the lack of progress wrongly, and ‘throw’ more money or management time, or both at the implementation to try an
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
establish a CI momentum, without succeeding.
If I can close with analogy once more – if CI is an expedition, surely you need t
If I can close with analogy once more – if CI is an expedition, surely you need t
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
understand your point of embarkation as well as your destination; you need to understand the organisation culture that you are
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ealing with before you embark upon your CI journey.
Tim has developed his own web blog (an unusual step for top Business Improv
Tim has developed his own web blog (an unusual step for top Business Improv
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ment gurus but an interesting development) that can be found at http://timfranklin.blogspot.com - and which I think this has the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
potential to become a useful tool for business leaders to reflect upon how they can lead and manage change in their organisation
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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