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Advice You - Leading Change - Fatal Results When You Force Timelines
Every leader of organizational change has a timeline. The Big Kahuna wants it done by such and such a date and that date becomes the gospel. There is just no changing it. Let me take you on a trip and show you why that is often fatal, for the project, the organization and
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
mostly the people involved.
Go back with me to the summer of 1967. It was in the northern provinces of South Vietnam and I was a sniper team leader with the U.S. Marines. It was my second consecutive year in country and we were assigned to go with a Marine infantry unit t
Go back with me to the summer of 1967. It was in the northern provinces of South Vietnam and I was a sniper team leader with the U.S. Marines. It was my second consecutive year in country and we were assigned to go with a Marine infantry unit t
; 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
a nasty place called the Street Without Joy located in Quang Tri Province. It was an area in the sand dunes with tree lines and hedge rows and villages.
You have to know that at that time the Marines carried the M-14 rifle. Twice each year we had to do what they called ‘
You have to know that at that time the Marines carried the M-14 rifle. Twice each year we had to do what they called ‘
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ield strip’ the rifle. This meant taking it apart and putting it back together, blindfolded in sixty seconds. The reason for the test was in case the rifle jammed at night, you could fix it quickly. In the case of the M-14, it was a little heavy but incredibly reliable so
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
amming was rare at best.
Enter our illustrious Defense Secretary, Mr. McNamara who was pushing all kinds of new stuff to publicly show his strong support for the U.S. troops fighting there. This is all well written about today, at the time it was much like what you hear i
Enter our illustrious Defense Secretary, Mr. McNamara who was pushing all kinds of new stuff to publicly show his strong support for the U.S. troops fighting there. This is all well written about today, at the time it was much like what you hear i
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
today’s media regarding Iraq. Long story short, the M-16 rifle was forced down the military’s throat with a rollout timeline that was nearly immediate.
The justification was that it was much lighter (think plastic), the ammunition was lighter (and smaller) and it would s
The justification was that it was much lighter (think plastic), the ammunition was lighter (and smaller) and it would s
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
oot much faster. If all that was true, and that was a stretch, it would have been okay except for the fact that it was barely tested. The thing was surely in what they call today ‘beta’ and not ready for prime time.
The Marines my snipers and I were with had M-14’s until
The Marines my snipers and I were with had M-14’s until
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
hree or four hours before the operation we were going on when Marine leadership, under the direction of those fine leaders we had in Washington, came by to rollout the new M-16. The Marines gave up their trusted M-14 and were handed the new toy M-16 with an hours training
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nd wished well – we headed out at the sign of darkness and headed for the Street Without Joy.
We arrived at near midnight and the plan was to ‘sit in’ until first light and sweep the local villages. We were ambushed and fought all night, at one point being overrun by the
We arrived at near midnight and the plan was to ‘sit in’ until first light and sweep the local villages. We were ambushed and fought all night, at one point being overrun by the
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
ad guys. It was an awful night. At first light the North Vietnamese broke off the fight and we were left to gather up the carnage. As the choppers came in for the severely wounded first, the Lieutenant asked me to get my snipers and gather the dead for their flight out aft
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r the wounded. It was pretty grim duty.
We gathered up nearly three dozen dead Marines and zipped them in body bags, and half of the dead had their M-16 rifles apart in their hands. They had jammed in the sand. This scene was relived across Vietnam for the next couple yea
We gathered up nearly three dozen dead Marines and zipped them in body bags, and half of the dead had their M-16 rifles apart in their hands. They had jammed in the sand. This scene was relived across Vietnam for the next couple yea
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
rs at least. Why? Because some tin soldier leader way back in headquarters made a macho decision to rollout an unproven and untested weapon that cost the lives of many great young Marines. Our leaders dutifully followed orders and their troops died with weapons that didn’t
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
work. That is a scene I relive time and again. It’s happening today in organizations across America and the World.
In the past eight years while consulting on change projects I have seen this same thing happen in organizations large and small. It is a leadership issue. In
In the past eight years while consulting on change projects I have seen this same thing happen in organizations large and small. It is a leadership issue. In
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
business and other peacetime organizations these actions don’t kill people, they just kill careers. When leaders blindly think they can ‘drive’ the timelines they don’t find success, it is an illusion they support by failing to ask the right questions.
I was involved in a
I was involved in a
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
Peoplesoft implementation for a $1.3 billion company. The consulting house told them they could design and implement in two years. We came in at the site of the train wreck two and a half years later when all they had implemented was the system in headquarters finance. Or
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
ow about an Oracle implementation, it was in a technology company doing around $500 million in sales and a year behind on their timeline with nothing on the street. We were called to get it on track. When we discuss the timeline all heads bow and silence enters the room.
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
nother fun time was with a company formed by several mergers and the new CEO, a fine GE Capital man, decided to implement the infamous SAP as his first project. He demanded it be done in under a year. Keep in mind that the company was formed with 11 other companies they pu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
chased and were bringing together. They would have done $600 million had they survived. But the lights dimmed when they turned on SAP, they couldn’t ship for a week or bill for three weeks and they died. It is split up and sold off and many careers went down the drain.
Pe
Pe
.
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
ple on high, dictating timelines disguised as leadership, are killing companies and careers today at an alarming rate. It is the same as my experience in Vietnam forty years ago. McNamara demanded certain things like Rumsfeld today. You can demand all you want but the real
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
ty is that based on the resources you commit and the scope of the change, times the quality of the work, will equal the time it takes to complete. You can edict all you want and it will bring you fatal results if you aren’t connected to the people doing the work.
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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