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Digg It - The Devil We Know
“I'm in an abusive relationship,” sighed Andrew. “My bookkeeper annoys the hell out of me but I just can't let him go. I keep hoping he'll improve… it's torture. Why do I do this to myself.”
“You've already answered tha
“You've already answered tha
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
t question,” I replied. “You're in an abusive relationship. Would you feel better knowing that many business owners are in the same boat? They've outsourced a task or made concessions to a delinquent account with hope of
; 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
reducing the stress, but it only made matters worse.”
“I'd be better off taking the bookkeeping back and doing it myself,” Andrew suggested.
“That's not dealing with the underlying issue,” I countered. “You outsourced
“I'd be better off taking the bookkeeping back and doing it myself,” Andrew suggested.
“That's not dealing with the underlying issue,” I countered. “You outsourced
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the bookkeeping because you're not good at it, so taking it back does not serve your primary goal. You need a bookkeeper that will do the task and serve you, the customer.”
“Right! But how do I get rid of him? He has m
“Right! But how do I get rid of him? He has m
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
files, my receipts, all my information. How do I get that back without starting a confrontation?” he asked.
“Oh, I see. You want to bail out but not deal with the consequences. So the issue is with you, not him. You'd
“Oh, I see. You want to bail out but not deal with the consequences. So the issue is with you, not him. You'd
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
rather stay with the devil you know than the devil you don't,” I said.
“So what's the better action?” he asked.
Andrew is struggling with a dilemma many business owners wrestle with: an unwillingness to confront poor p
“So what's the better action?” he asked.
Andrew is struggling with a dilemma many business owners wrestle with: an unwillingness to confront poor p
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
erformance. Whether it's with an employee, an overdue account or a business relationship, they would rather bitch and complain about a lack of performance than deal with the fallout. The pain associated with a focused, c
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
rrective action is greater than stretching it out over time. Do you take off the bandage in a quick rip, or are you prone to pull it off hair by hair? Do you plunge into the cold lake, or slowly wade in?
“Actually your
“Actually your
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
problem is the result of not taking action. You're enduring the suffering because you refuse to go through the process of letting him go and finding someone more competent,” I replied. “This is all about you.”
Oftentime
Oftentime
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
s when we are faced with challenges, we place the blame 'out there'; someone or something is doing us wrong. But in reality, we're just refusing to get clear on what we want. And if you're not clear on what you want, you
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
can't initiate a decisive action.
In most situations where inferior performance is causing grief, we know what corrective action is needed but we will do almost anything to avoid going through the anguish that a focused
In most situations where inferior performance is causing grief, we know what corrective action is needed but we will do almost anything to avoid going through the anguish that a focused
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
action brings. In Andrew's case, terminating the relationship and retrieving the information, plus starting over with someone new, was daunting enough to override his frustration with the current situation. So instead o
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
f dealing with the real issue, Andrew is left to manipulate consequences. We go to silly extremes to avoid pain, like pulling off the bandage hair by hair!
Getting clear is always the first step. What outcome do you wan
Getting clear is always the first step. What outcome do you wan
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
t? Plotting the action to achieve that outcome is the second step. If you're not clear on what you want, any action you take will only complicate the situation. And since most people avoid getting clear first, they land
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
p manipulating the consequences of hanging onto the devil they know.
“What do you want the outcome to be?” I asked Andrew. “Tell me in 10 words or less.” Once you're clear, few words are needed.
“To get my bookkeeping
“What do you want the outcome to be?” I asked Andrew. “Tell me in 10 words or less.” Once you're clear, few words are needed.
“To get my bookkeeping
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
on track and up-to-date,” Andrew replied.
“Great! And what action will that take?”
“Deal decisively with my current bookkeeper, get my stuff back and find someone new,” he replied.
“Right! But not just 'someone new',
“Great! And what action will that take?”
“Deal decisively with my current bookkeeper, get my stuff back and find someone new,” he replied.
“Right! But not just 'someone new',
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
you want someone competent. Remember that your clarity will determine how decisive your action – and the response to it – will be. So if you give your bookkeeper another chance or leave it to him to return your files, yo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
r wavering will have a consequence on the outcome. If you're going to 'rip the bandage off' then make the action complete. A half-assed action only complicates things.”
Hanging out with the devil we know is a common bus
Hanging out with the devil we know is a common bus
.
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
iness habit. How often do you cajole with customers or network with clients even though you know the possibility of ever doing business with them is remote. Instead of moving on and finding new leads or business relation
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
ships, you fool yourself with a false sense of comfort. Why invest your time and money and more importantly, your emotional substance, into relationships that will never bear fruit?
Like Andrew, we really do know better
Like Andrew, we really do know better
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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