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Cases - Leading Change - Be Careful What You Push For
"When two trains are approaching each other at a crossing, they shall both come to a full stop, and neither shall start up again until the other
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
has gone." That is a quote from actual railway law some years ago. We all know with what authority these bureaucracies are built. You will not
; 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
succeed doing it this way.
If you're trying to lead change in an organization overflowing with bureaucracy you'd better get ready for some figh
If you're trying to lead change in an organization overflowing with bureaucracy you'd better get ready for some figh
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ts. In one company where we worked to drive a big change project, the bad guys running the bureaucracy came bubbling out of the woodwork like 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
gusher of bad crude.
It was the end of the quarter and the changes we were working on were far from complete. They weren’t even scheduled for c
It was the end of the quarter and the changes we were working on were far from complete. They weren’t even scheduled for c
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
mpletion for another nine months but that didn’t stop the head of manufacturing from driving sales orders straight out the back door whether the
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
product was ready or not. Never mind the fact the handhelds we were working on didn’t pass the motherboard burn in tests, they overheated. In s
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
ome cases, the heat was actually causing damage to the plastic case they were housed in. It was bad.
In spite of the dogs of bureaucracy nippin
In spite of the dogs of bureaucracy nippin
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
g at his heals the head of quality was sticking to his guns. That is until the manufacturing manager, who he worked for, turned ugly. He was tol
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
d in no uncertain terms that he would ship those handhelds that were on hold or he'd find someone else who 'could get the job done'.
It was an
It was an
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
our long tirade that brought the quality guy to his knees.
"Yes, I understand and I can ship those new motherboards. But with that motherboard
"Yes, I understand and I can ship those new motherboards. But with that motherboard
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
overheating like it is, I'll need a little time to get hold of some of those tiny little air conditioners to put on the back of each one to cool
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
them down ... you know, so they don’t burn the customers hands."
He had guts, it was funny at the time but I tell you, the guy made us ship th
He had guts, it was funny at the time but I tell you, the guy made us ship th
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
em anyway. It was a train wreck. I couldn’t get the CEO to override the manufacturing guy so our project was about to be put on hold to pick up
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
these pieces.
The debacle that day came about because we had a guy who pushed for what he wanted, not what the project needed or the customer o
The debacle that day came about because we had a guy who pushed for what he wanted, not what the project needed or the customer o
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
anything. He got his way. You cannot let that happen or you fail, like we did in this case. Unfortunately, it does happen all too often.
As a
As a
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
change leader you must look out for people like the one described above. You must smoke them out long before you’re in a box like this one. In t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
his case as well, the CEO, who was behind me driving the change, stood with the manufacturing guy so they could drive the quarter for Wall Stree
.
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
t. The company later went down and those two with it.
"Change is inevitable, except from vending machines." If you're driving change with a few
"Change is inevitable, except from vending machines." If you're driving change with a few
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
vending machines for leaders, the you’ll fail. No question about it ... be careful and watch what you push for - you just may get it.
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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