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E-Folder - Entrepreneurial Inertia
From the moment a business is launched, a phenomenon begins to take over. The ant
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
i-entrepreneurial inertia begins to set in.
Every business starts out entreprene
Every business starts out entreprene
; 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
urial. Hungry and eager, innovative, open-minded and resourceful, all of its atte
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tion focused on finding and keeping customers.
Things start to happen and the bu
Things start to happen and the bu
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
siness begins to grow.
Meanwhile, something sinister begins to occur. Slowly, su
Meanwhile, something sinister begins to occur. Slowly, su
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tly and insidiously, the anti-entrepreneurial inertia begins to creep in.
As the
As 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
business continues to grow, we take on more and more responsibility. We hire oth
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
er people, who now need to be managed. We establish policies and procedures, rout
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nes, and rituals as part of our success strategy.
Our focus has begun to shift.
Our focus has begun to shift.
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
Without realizing it, we’ve grown a little less curious, a little less open-minde
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
and a little less attentive to the needs of our customers.
Soon we become “expe
Soon we become “expe
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
rts” in our field. We’ve achieved success. We know all there is to know about our
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
particular field of endeavor. We’ve established an identity or a culture within
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
ur organization.
Without realizing it, we’ve lost our entrepreneurial zeal. We’v
Without realizing it, we’ve lost our entrepreneurial zeal. We’v
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
e grown less open minded, now focused on protecting what we have rather than scou
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 the horizon, looking for what we don’t.
We stop listening. We stop learning.
We stop listening. We stop learning.
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
We ignore or deny the changes that are occurring all around us. (Think Maxwell H
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ouse vs. Starbucks)
Without realizing it we’ve moved to the other end of the spe
Without realizing it we’ve moved to the other end of the spe
.
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
trum. Without realizing it we’ve become complacent.
Without realizing it we’ve c
Without realizing it we’ve c
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
reated an opportunity for the next eager and innovative, open-minded entrepreneur
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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