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Business Articles - Managing Change; Ten Signs of Organisational Decay
Many once great organisations have disappeared over time. They may have been unable to stem the tide of technical innovation or the entrance of low cost competitors or in the public arena they may have become irrelevant as service providers.
Mos
Mos
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
tly they have sown the seeds of their demise many years before, missing the tell tale signs and hence being powerless to do anything about it. Here are my top ten signs of organisations losing relevance and heading for oblivion.
Everybod
Everybod
; 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
y agrees.
When there is no dissent in an organisation it means one of three things. The boss is so dominant that no-one dares to contradict what he or she says. In this case the boss had better be perfect as they will make all the decis
When there is no dissent in an organisation it means one of three things. The boss is so dominant that no-one dares to contradict what he or she says. In this case the boss had better be perfect as they will make all the decis
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ions. I am yet to meet anyone befitting that descriptor.
Alternatively, everyone is working in silos, uninterested in what happens in other functions or in the boss's domain. A slow death of confused objectives, wasted effort an
Alternatively, everyone is working in silos, uninterested in what happens in other functions or in the boss's domain. A slow death of confused objectives, wasted effort an
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
d low productivity ensues from this warning sign. Thirdly, everyone may be asleep.
Data shows that there is little room for improvement.
When organisations coast and do not reinvent themselves they are in trouble. When their an
Data shows that there is little room for improvement.
When organisations coast and do not reinvent themselves they are in trouble. When their an
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
alysis tells them they do not have to change and adapt they will be blindsided by some change in the market or technology. If their data says there is no room for improvement, the data is wrong or the interpretation severely flawed.
Ther
Ther
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
e is no cost pressure.
Technology, reduction in trade barriers and the relentless internationalisation of companies means that there are only two types of cost pressures. The ones you see and the ones you don't.
There is only c
Technology, reduction in trade barriers and the relentless internationalisation of companies means that there are only two types of cost pressures. The ones you see and the ones you don't.
There is only c
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
ost pressure.
When organisations get locked in on cost reduction without a purpose e.g. reducing costs to gain or retain market share or reducing costs to generate cash to invest or reduce debt, they enter a death spiral. The death spi
When organisations get locked in on cost reduction without a purpose e.g. reducing costs to gain or retain market share or reducing costs to generate cash to invest or reduce debt, they enter a death spiral. The death spi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ral ends with the golden dollar; the last dollar to be saved as the lights are turned out.
Decisions are not made.
Initiatives are trapped in endless rounds of deliberations by subcommittees rather than subjecting them to rigor
Decisions are not made.
Initiatives are trapped in endless rounds of deliberations by subcommittees rather than subjecting them to rigor
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
ous risk analysis and contingency planning. The organisation paralyses like a rabbit in the headlights of change and becoming just another piece of road-kill.
Progress is difficult to define.
When one year appears to be no bett
Progress is difficult to define.
When one year appears to be no bett
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r or worse than another, just different, it means that no matter what the vision statement shingle says, the organisation has no vision or goal that is measurable. It does not know where it is going and will get to somewhere that it does not know
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
, but does not like.
Risks are not knowingly being taken.
This is a double edged sword, risks can be known but not taken or unknown and inadvertently taken. At some time, cumulative aversion of risks will result in a very low r
Risks are not knowingly being taken.
This is a double edged sword, risks can be known but not taken or unknown and inadvertently taken. At some time, cumulative aversion of risks will result in a very low r
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
eturn. Continued inadvertent taking of unknown risks courts a quick end to an organisation.
Projects are always late or change in scope.
Continued delays in delivering the benefits of projects will result in an accumulation of
Projects are always late or change in scope.
Continued delays in delivering the benefits of projects will result in an accumulation of
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
increased costs and reduced benefits with. Continued changes in scope not only has an impact on the cost benefit of projects but also demonstrates a lack of planning in a project and/or will on part of the executive team.
In either case, organis
In either case, organis
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
ations that display poor planning or poor will to keep to a plan will be significantly less productive than organisations that do not suffer from this malaise.
No-one is a poor performer.
When no-one gets feedback that they cou
No-one is a poor performer.
When no-one gets feedback that they cou
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
ld do better and are made to understand clearly what is expected of them then either the organisation has robots for staff or the have no sense of what are the minimum standards of performance and what are stretch targets for individuals.
Having
Having
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
no minimum standards of performance or stretch targets for people drives performance to a lowest common denominator and a gradual spiral into mediocrity.
Organisations that are in trouble do not arrive there suddenly. Even if they believe that
Organisations that are in trouble do not arrive there suddenly. Even if they believe that
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
the cause was sudden such as a devaluation that exposed them to foreign currency losses or a recession that arrives quickly and collapses sales, the seed of their problems is evident many years before.
Organisations that regularly take a good ha
Organisations that regularly take a good ha
.
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
rd look in the mirror at themselves tend to avoid the worst of sudden changes in fortune. They may choose to do so at their annual retreat or at an annual challenge session where the executive team complete a "what if" analysis to see if their st
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
rategies and tactics are still suitable to achieve a goal which is still appropriate.
Organisations when facing the implications of a sudden change in fortune that complain about their bad luck start or continue the steady decay into irrelevance
Organisations when facing the implications of a sudden change in fortune that complain about their bad luck start or continue the steady decay into irrelevance
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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