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Useful Advices - Go Slow to Go Fast
I’ve been telling people this for several years. The admonishment, for me, began with my work teaching Quality Improvement at Chevron. In that work we found,
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
to no one’s surprise, that people often focus on the task - solving a problem - much more than on the process - understanding its causes (and planning solut
; 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
ons accordingly.)
Most of us in western culture can easily focus on solving a problem or removing a barrier. After all, we know what’s wrong - just fix it!
Most of us in western culture can easily focus on solving a problem or removing a barrier. After all, we know what’s wrong - just fix it!
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
As all of us know from experience, the bias for action (a task focus) often leads to incomplete solutions, solutions that cause more problems (maybe ones wor
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
e than the original), solutions that don’t solve.
Go slow to go fast.
By taking time to focus on process - how we solve the problem - and using some sequen
Go slow to go fast.
By taking time to focus on process - how we solve the problem - and using some sequen
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e of steps that include understanding the causes of the problem often we achieve better results. The rub is that these steps may seem like they take a lot of
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
time. In the moment, that time is often seen as wasted ("Let’s just solve the problem!").
Go slow to go fast.
Several current happenings have coalesced re
Go slow to go fast.
Several current happenings have coalesced re
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
ently to remind me of this saying (yes I hear myself telling others in my own voice!) On the flight from Chicago to Oakland recently, I was reading a book an
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
put it down with nearly two hours remaining in the flight. This is very odd behavior for me, especially when I am truly enjoying the book. I put it down bec
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
ause I decided some reflection would make the book more valuable and more enjoyable.
Go slow to go fast.
After I had put it down and was contemplating what
Go slow to go fast.
After I had put it down and was contemplating what
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
I had read, the flight attendant came by to pick up empty drinks. She mistakenly thought my Coke was empty. As she quickly started to pick it up it spilled (
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
ostly on me!) She certainly didn’t intend to spill it and she was very helpful in my cleanup efforts. The point is, she ended up spending much more time with
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
me than she would’ve had to if the Coke hadn’t spilled. Slow down to go fast. A trivial example? Perhaps. But often the greatest truths are seen in the simp
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
est acts.
This phrase is also in my consciousness as I work with a colleague to build a workshop on consulting skills. This workshop will feature much time
This phrase is also in my consciousness as I work with a colleague to build a workshop on consulting skills. This workshop will feature much time
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
or reflection, personal learning and process. I’m hoping to impress, through my actions, the importance of process - the importance of slowing down.
There a
There a
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
re examples, large and small, of this advice all around us. Since I started this Vantagepoints I’ve seen many! (Including my tendency to hand write notes too
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
quickly, which make it hard for the reader to read, and may cause miscommunication, etc.)
I urge you to think about the application of this thought to your
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ife. I am sure you will come to the same conclusion I have - that we can often improve our results simply by slowing down and focusing on process as well as
.
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
task.
When you come to this conclusion, I urge you to pick one task or problem you are working on and apply this advice. Slow down. Focusing on the process
When you come to this conclusion, I urge you to pick one task or problem you are working on and apply this advice. Slow down. Focusing on the process
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
ou are using to solve the problem will bring clarity and help you avoid mistakes. It may be a bit frustrating, but in the long run it will be time well spent
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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