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Digg It - 5S Can Pave the Way to Lean Success
Paul Wilson, Managing Director of Aster Training has rolled out many 5S implementation programmes for companies throughou
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
t
the UK.
Paul takes up the story, “Some organisations we work with initially tend to think they have a unique set of
Paul takes up the story, “Some organisations we work with initially tend to think they have a unique set of
; 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
roblems or operating conditions which would make 5S and the other lean tools difficult to implement. The reality tends to
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
be very different. Once we get over the initial hurdle of the ‘buy-in’ of the management team, progress and improvements
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
can be rapid.
The mechanics of 5S implementation are relatively easy and straightforward but where organisations can mak
The mechanics of 5S implementation are relatively easy and straightforward but where organisations can mak
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
a mistake is by failing to build in objective review mechanisms designed to identify how far the workforce has bought in
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
to the programme. 5S is about making everyone responsible and accountable for their work areas, not just the enthusiastic
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
few.
5S is also a company wide improvement programme and therefore needs ‘champions’ in every partcipia
5S is also a company wide improvement programme and therefore needs ‘champions’ in every partcipia
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ing area both ‘talking the talk’ and
‘walking the walk’on a daily basis. If this is not achieved early on it is likely t
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
he company will have difficulty sustaining the project in the longer term. Failure at this early stage will make it very
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ifficult to resurrect the 5S project at a later date because of the entrenched views and attitudes generated as a result
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
f initial failure.
It is therefore essential we get it right first time. At Aster we focus heavily on building the confi
It is therefore essential we get it right first time. At Aster we focus heavily on building the confi
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
dence of the 5S project leaders by getting them to use an Aster designed ‘structured framework’ of prior
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
ty based
implementation activities. This allows the project leaders to follow a ‘proven path to 5S success’ freeing up t
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
eir time to act as both mentors and coaches to their team members thus ensuring the smooth introduction of the programme.
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
By doing it this way we can bring about sustainable cultural change within an organisation thus making it easier to impl
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
ment other lean manufacturing tools when the time is right”.
Additional Notes
5S is one of the cornerstones of a
Additional Notes
5S is one of the cornerstones of a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lean manufacturing programme.
5S, also known as 5C or CANDO is concerned with the elimination of the ‘7 wastes’ by the i
5S, also known as 5C or CANDO is concerned with the elimination of the ‘7 wastes’ by the i
.
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
ntroduction of world class workplace organisation and housekeeping.
What are the 7 Wastes - By reviewing just 7 wastes
What are the 7 Wastes - By reviewing just 7 wastes
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
n our business, we can account for over 80% of the waste we are likely to find in both our office and factory environment
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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