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Your Space - Five Reasons Why Leaders Fail to Create Successful Change
A bold title, don’t you think? I mean, change is a complex thing, so to define five reasons seems to oversimplify the issue.
Let me be clear. There are far more pitfalls than these and far more possible reasons change doesn’t ha
Let me be clear. There are far more pitfalls than these and far more possible reasons change doesn’t ha
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
ve the desired effect. The key in this title isn’t “Five Reasons,” it is “Leaders Fail.” Yes, there are many variables that can influence the success of change – but some of them must be owned by those leading the change.
This a
This a
; 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
ticle will identify some of those typical failures, and while it can’t in this brief format give you all the answers, it can point you in the right direction and give you some suggested courses of action.
Lack of Commitment
Lack of Commitment
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
George knew he had to shake things up in his team. Other departments were complaining that his department wasn’t responsive or even accurate in their work at times. So he started looking for ways to improve some work processes a
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 get the team’s attention. He held a couple of meetings to explain the situation and ask for suggestions. He even got volunteers to look at some of the work processes and got the group some help to make this happen. But deep do
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
n, George didn’t want to make these changes. He was happy with his team. He didn’t have any major problems internally and was afraid these work process reviews were going to reveal that he had people that would need to go.
Georg
Georg
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 was mouthing the words of change, but he wasn’t really committed to the change himself.
Want to create successful change? Get committed!
Lack of Communication
Lisa had explained the case for change clearly, so she thou
Want to create successful change? Get committed!
Lack of Communication
Lisa had explained the case for change clearly, so she thou
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
ht. She even talked to some of her VP’s and Department Heads and they agreed – her message was firm, strong and hopeful. Everyone should clearly understand the reasons for this change and the steps that the organization would be
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
aking. Three months later Lisa wondered what had gone wrong. What she didn’t realize was that successful change requires more than just great initial communication – it also requires ongoing formal and informal repeating of these
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
messages. Communicating and communicating; both for clarity and for comfort, so people really get it.
Want successful change? Communicate, communicate and communicate. Early and often, formally and informally.
Lack of Patie
Want successful change? Communicate, communicate and communicate. Early and often, formally and informally.
Lack of Patie
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ce
Tom got it. He really understood why this change was important. Admittedly, it took him awhile to really get on board, but once he got it, he was 100% committed. Soon he was showing impatience with everyone else, asking h
Tom got it. He really understood why this change was important. Admittedly, it took him awhile to really get on board, but once he got it, he was 100% committed. Soon he was showing impatience with everyone else, asking h
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
imself things like: Why isn’t this change happening faster? Why aren’t people on board? Why is there still resistance? Unfortunately he forgot how long it took him to really get committed. Tom made the mistake of assuming that
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
veryone “gets it” at the same rate. It takes some people longer to become comfortable with a change. It doesn’t make them bad or dumb or lazy or unmotivated. The fact is not everyone gets on board the same day.
Want successful c
Want successful c
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
ange? Be patient and realize that lasting change will take time.
Lack of Emotion
Lois had laid out the plan. Her logic was impeccable. She had been meticulous in explaining the reasons for the change and the steps that w
Lack of Emotion
Lois had laid out the plan. Her logic was impeccable. She had been meticulous in explaining the reasons for the change and the steps that w
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
uld be taken. She described what the organization would look like when the change was complete. She has answered every question patiently and completely. And she was surprised that the change effort was falling flat. What had sh
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
done wrong? Everything she did was fine, just incomplete.
Incomplete, because Lois focused on getting people to understand the change, and this isn’t the same as accepting the change. Acceptance requires more than just the fact
Incomplete, because Lois focused on getting people to understand the change, and this isn’t the same as accepting the change. Acceptance requires more than just the fact
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
s and figures.
Want successful change? Remember that people need more than the facts. They need to understand the change emotionally and intuitively in order to accept and embrace the change – and you want acceptance, not unders
Want successful change? Remember that people need more than the facts. They need to understand the change emotionally and intuitively in order to accept and embrace the change – and you want acceptance, not unders
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
anding.
Lack of Knowledge
Mike knew he had to make a change in his organization. But he had lived through so many unsuccessful change efforts that he didn’t know if it was possible to really create meaningful change. He
Lack of Knowledge
Mike knew he had to make a change in his organization. But he had lived through so many unsuccessful change efforts that he didn’t know if it was possible to really create meaningful change. He
.
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
as committed to the change, believed in it, but didn’t know how to make it happen. He didn’t even know where to start.
Want successful change? Learn what you need to do to succeed!
In Closing
The five reasons why leader
Want successful change? Learn what you need to do to succeed!
In Closing
The five reasons why leader
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
fail to create successful change:
• They aren’t committed
• They stop communicating too soon
• They aren’t patient
• They don’t present an emotional case for change
• They don’t know how
Which reasons are getting in your way
• They aren’t committed
• They stop communicating too soon
• They aren’t patient
• They don’t present an emotional case for change
• They don’t know how
Which reasons are getting in your way
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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