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Subjects - Leading a Business; Getting Lost in Generalities
Leaders of small businesses have no trouble thinking specifically about their business, its goals and the resources and processes required to reach the goals. If they don't they "go broke" very quickly. Why is it then that in big organisations t
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
hat managers of even small departments get lost in a fog of generalities?
How do we know when an organisation is lost in the fog? The symptoms to watch for include the use of management phrases which make no sense, the inability to confront rea
How do we know when an organisation is lost in the fog? The symptoms to watch for include the use of management phrases which make no sense, the inability to confront rea
; 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
problems and the inability to grasp real opportunities.
To some readers it may seem trite to think of overuse of management phrases and management models as being a symptom of not thinking seriously enough about the organisation. My experience
To some readers it may seem trite to think of overuse of management phrases and management models as being a symptom of not thinking seriously enough about the organisation. My experience
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tells me otherwise. The most popular phrase I know of in Australian senior management circles now is "going forward". If they could really go backward in time then they would not need to run their organisation to make billions.
The phrase adds
The phrase adds
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
othing to what they are saying and lacks the specificity of next quarter or next year or within three years. It is a popular term precisely because it lacks specificity. It does not force leaders to pinpoint a time by which they expect and event
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
to happen.
Other examples of behaviour of the same genre are fascination with management fads. The growth in management fads and consultant tools has been exponential since the 1960s. Has management of organisations become exponentially complex
Other examples of behaviour of the same genre are fascination with management fads. The growth in management fads and consultant tools has been exponential since the 1960s. Has management of organisations become exponentially complex
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
My view is that the answer is no. People in my profession have tried to make it more complex with single point solutions for every organisational ill that there is. Business however, in both the public and private sectors is still about matchi
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
g your capabilities to meet or exceed customer and stakeholder expectations.
Leaders need to build organisations who understand who their customers are, who their stakeholders are, what the expectations of each are and how to build the capabili
Leaders need to build organisations who understand who their customers are, who their stakeholders are, what the expectations of each are and how to build the capabili
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
y to meet or exceed those expectations.
In larger organisations the responsibilities for doing this are delegated. Business controls are put in place then to make sure that the responsibility is accepted by subordinates and accountability accep
In larger organisations the responsibilities for doing this are delegated. Business controls are put in place then to make sure that the responsibility is accepted by subordinates and accountability accep
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
ed by leaders. Business is more complex, but not exponentially so. The vast majority of consultant tools are therefore redundant once a few are used to help communicate issues and insights.
The inability to confront real problems stems from two
The inability to confront real problems stems from two
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
aspects. One is the inability of organisations to think specifically about its customers, stakeholders, goals and capabilities. The other is an inability to communicate. The former is related to the previous discussion. The latter is another sub
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
ject altogether.
Inability to communicate the real problems stems from one or more of four organisational issues.
The first is the inability to view a problem other than from within the frame it has always been viewed. People who view problems
Inability to communicate the real problems stems from one or more of four organisational issues.
The first is the inability to view a problem other than from within the frame it has always been viewed. People who view problems
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
from a different frame of reference are regarded as mavericks.
The second is an inability to communicate to people with different thinking styles and backgrounds. This is a skill problem.
The third is an unwillingness to communicate bad news.
The second is an inability to communicate to people with different thinking styles and backgrounds. This is a skill problem.
The third is an unwillingness to communicate bad news.
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
The fourth and the most unrecognised whilst being equally debilitating, is the communication by PowerPoint syndrome that afflicts so many organisations. Reports are no longer written or read. Discussions are rarely actually had. The organisation
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
s world is revolves around "The Presentation". People spend inordinate hours developing the presentation to get an acceptable message across rather than just telling it like it is.
Recipients of these "Presentations" are equally focussed on whe
Recipients of these "Presentations" are equally focussed on whe
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
e "The Presentation" fails to be compelling, to critique the presenter, rather than listen to the message, question for improving clarity and critiquing the suggestions for action.
The usual manifestation for me of a failure to grasp opportunit
The usual manifestation for me of a failure to grasp opportunit
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
es is in the stated notion of "playing devils advocate". People who agree that a goal is desirable and of high priority and then set about articulating why the strategy or the actions planned are not sufficient to reach the goal, are in my opini
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
n, lazy.
They do it not to force some critical thinking on a group, but to make a personal point. They have completed only half of the work. The barriers to success are clearly articulated. What they need to do is to find ways to remove or nega
They do it not to force some critical thinking on a group, but to make a personal point. They have completed only half of the work. The barriers to success are clearly articulated. What they need to do is to find ways to remove or nega
.
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
e the impact of the barriers. They need to articulate their thoughts as what needs to be done to be successful.
Getting lost in a fog of generalities is symptomatic of leaders who lack the "helicopter quality" to deal with the specifics in the
Getting lost in a fog of generalities is symptomatic of leaders who lack the "helicopter quality" to deal with the specifics in 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
ontext of the generalities of the business. When they fail as they often do, they fail without knowing why. Those who do master the specifics may also fail. However, at least they know why and learn from their mistakes, rather than repeating the
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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