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Just Other Articles - Managing Change - The First Key to Helping People to Embrace Change
“Life is a movie and you’re the star, give it a happy ending.” Joan Rivers the actress and comedienne said that and it really applies to dealing with and coping with change in your organization and life. I learned
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
about this as a Marine sniper in the jungles of Vietnam. I might have found myself there as part of the United States Marine Corp but what I made of the experience was up to me. It is serving me to this day.
Whe
Whe
; 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
you are leading or managing change the people under your charge will have varying reactions to the changes taking place. Few will embrace it out of the blocks, many will struggle. You can help. As popular speaker
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
Larry Winget says, “Shut up, stop whining and get a life!”
The very first thing you must help people do, in a kind, yet straightforward way, is to help them go home and look in the mirror. Each of us needs to hav
The very first thing you must help people do, in a kind, yet straightforward way, is to help them go home and look in the mirror. Each of us needs to hav
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
a stop kidding yourself day. Teach them to ask, “Where are my present practices taking me?” That means that if I continue to react and behave in the way I am, regarding these changes – where will I be?
You see p
You see p
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ople need to understand that once you launch the ‘change’ it is going to proceed in that direction … the choice is in how they react. Understanding this principle came early to me. My first patrol in Nam as a snip
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
r came with a Force Reconnaissance team in the mountains near Laos. We planned a ten day patrol and my partner and I took just enough c-rations for the ten days, barely. We didn’t want to carry the extra weight.
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
Well, at the end of ten days, for whatever reason, the choppers didn’t come to get us. A tough Recon sergeant, knowing we were out of food, came by and said, “No whining.” It was three days before the choppers cam
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
… we didn’t eat for three days. Now that was change, but we lived and we learned and we changed. The good people in your organization will learn too.
Understanding this first hand has led me to create the first
Understanding this first hand has led me to create the first
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
ey to helping people embrace change and that is to decide whether you want to stay with the organization. I created a test I give people in my How to Cope workshop that is designed to make them face the fact that
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
hings are changing and they can get with the changes or they should lead. It’s just a fact.
The test goes something like this …
1. The first question is do you still have a job? If you don’t have a job then move
The test goes something like this …
1. The first question is do you still have a job? If you don’t have a job then move
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
on, stop the test and focus on finding a new one. Your change is different.
2. The second question is what are the facts that you know to be true as they relate to you? We all know all the horriblizing that goes
2. The second question is what are the facts that you know to be true as they relate to you? We all know all the horriblizing that goes
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
n during change, here, we just want the people to focus on what is true about the changes as it relates to them.
3. The next question relates to now you know some facts, how do they impact you personally? This is
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
just getting people to ‘get real’. Do these changes actually impact you, or are they impacting others and you are ‘projecting’ those changes on you? It pays to understand and be sure.
4. There are some other ques
4. There are some other ques
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
tions in between, but for this article lets focus on this … are you in denial about anything you see and what do you fear? Here you get the folks to come clean and stop kidding themselves.
5. The next couple ques
5. The next couple ques
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
ions focus the individual on how they are behaving and feeling about the changes. You cannot change that which you do not acknowledge. The focus has to be on getting real and doing something about it.
6. The last
6. The last
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
focuses on this question … is your situation hopeful or helpless? While this needs further explanation, if it is hopeful to you, then stay and work it out. If it is helpless … get out now.
The key to helping you
The key to helping you
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
people move to embracing change and not fighting it is to get them to make a choice, based on their answers, whether to go or stay. If someone simply can’t get with the program then for their own mental and physi
.
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
al health they should choose to go. It should be civil, you should help them, but they should not stay.
On the other hand if someone chooses to stay, as most will, then they need to understand that while you want
On the other hand if someone chooses to stay, as most will, then they need to understand that while you want
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
and need feedback on the process, resistance is not acceptable. It is important that this message be delivered in the beginning of the change process. Otherwise, have fun in the carnage that will follow.
Ed Kugle
Ed Kugle
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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