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Just Other Articles - Is Your Company the Real McCoy?
One of my favorite Gary Larson cartoons is the one
with the cardboard cutouts of a hillbilly family on
the lawn of their mountain shack. The caption reads:
The Fake
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
McCoys.
The term "Real McCoy" most likely comes from a railway invention by Elijah McCoy that automatically dripped oil to critical parts of the train instead of havi
The term "Real McCoy" most likely comes from a railway invention by Elijah McCoy that automatically dripped oil to critical parts of the train instead of havi
; 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
g
to stop and let the oilman do it manually.
Even though Elijah applied for and was granted a US Patent, there were many imitators. But none of them were as good as
Even though Elijah applied for and was granted a US Patent, there were many imitators. But none of them were as good as
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 "Real McCoy".
How about you and your company? Are you the Real McCoy?
Or are you trying to be something you're not? Are you trying to imitate your competition inst
How about you and your company? Are you the Real McCoy?
Or are you trying to be something you're not? Are you trying to imitate your competition inst
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ad of being
yourself?
I see far too many small companies trying to look like big companies. I see big companies doing their best to come across as a small-town comp
I see far too many small companies trying to look like big companies. I see big companies doing their best to come across as a small-town comp
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ny. There are old
enterprises attempting to look fresh and new, while
brand new ones are trying to appear well established.
All of these efforts burn up time, energy
All of these efforts burn up time, energy
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
nd
resources. They rarely work well--if they work at all.
People like to do business with people they like. And they like people who are like themselves. They don't
People like to do business with people they like. And they like people who are like themselves. They don't
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
really do business with a company--they do business
with the people IN that company.
Buyers today are savvy. They have more choices than ever before. And they can te
Buyers today are savvy. They have more choices than ever before. And they can te
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
l--at least at some
level--whether or not the company and the people in it
are congruent. They seek out, resonate with and tend
to be loyal to companies that are aut
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
entic.
It's not only a good thing to do, it's good business.
Your uniqueness and the things you're best at doing are all part of your differentiating position. It's
It's not only a good thing to do, it's good business.
Your uniqueness and the things you're best at doing are all part of your differentiating position. It's
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ho you are--your identity. It's what people can relate
to. If there's anything false, made up or covered
over, your prospects will sense it. And they won't
even be a
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
le to tell you why they didn't buy.
As Emerson said so eloquently, "Who you are speaks so loudly, I can't hear what you say."
The company that knows who they are, know
As Emerson said so eloquently, "Who you are speaks so loudly, I can't hear what you say."
The company that knows who they are, know
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
what
they're really good at and communicates that
effectively--without trying to be all things to all
people--is usually way ahead of the pack.
Is it easy? No, I d
Is it easy? No, I d
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
n't think so. But it IS easier
than trying to be something you're not.
Authenticity is Pillar Number One of the World Class Principles. This principle--authenticity--
Authenticity is Pillar Number One of the World Class Principles. This principle--authenticity--
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
is the most
challenging and yet perhaps the simplest of all the
10 Pillars. Much like your core values, your authentic
self isn't something to create but rather somet
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
ing
to discover.
Be who you are--no one else is better qualified.
Most people--and most organizations--have not really thought about this. It starts with realizing t
Be who you are--no one else is better qualified.
Most people--and most organizations--have not really thought about this. It starts with realizing t
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
at this
process is worthy of some introspection.
And it requires that we answer some tough questions.
Who are we? Who are we being? How do we come across? What do we
And it requires that we answer some tough questions.
Who are we? Who are we being? How do we come across? What do we
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
stand for? What are our core values? This
goes far beyond our mission and our vision. It may be
based on mission/vision, but it's more about the
culture of our organ
.
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
zation and how that culture is
showing up in our business dealings.
And this process is ongoing. It demands that we get real. If we don't, we should prepare to become
And this process is ongoing. It demands that we get real. If we don't, we should prepare to become
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
real irrelevant.
If we're diligent to the task, and honest and true to ourselves and those we serve, we can have a company that everyone will know as the Real McCoy
If we're diligent to the task, and honest and true to ourselves and those we serve, we can have a company that everyone will know as the Real McCoy
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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