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Useful Advices - Do You Know and Plan For The 3-R's for Your Business?
Everyone is familiar with the 3-R’s from school – reading, ‘riting and ‘rithmetic. This was our first introduction to an eff
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
ective performance model. As proficiency increased in each R, performance was further enhanced. Effective performance models
; 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
by their very design are a continuum that automatically raises performance to the next level.
Today’s businesses have their
Today’s businesses have their
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
own 3-R Performance Model. This model hasn’t really changed since the early of origins of business enterprises. No matter w
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hat the latest business guru advocates, good business practices and most importantly the “bottom-line” always appear to retu
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
n to these basic 3-R’s. For without Relationships, Referrals or Revenue, today’s businesses will not achieve current goals
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
or grow.
R1 – Relationships - With the Internet providing immediate access to unlimited vendors, products and services, to
R1 – Relationships - With the Internet providing immediate access to unlimited vendors, products and services, to
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
day’s business owners must develop sustainable and loyal relationships. Current customer service research suggests that the
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ost to attract a new customer or client is 10 times greater than to maintain an existing customer. Relationships lead to the
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
second R.
R2 – Referrals - Referrals according to recent research account for 84% of all sales. This research supports what
R2 – Referrals - Referrals according to recent research account for 84% of all sales. This research supports what
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
our common sense tells us about human nature. We are more likely to believe a close friend and probably a not so close frien
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
d over the slick Madison Avenue advertising efforts. Additionally, only 1 in 26 dissatisfied clients will share their dissat
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
sfaction with the organization, but will be more than happy to share their “bad” experience with others.
Referrals add valu
Referrals add valu
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
to the bottom line by reducing marketing dollars. You can’t “pay” for referrals. Referrals are given free much like a fri
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
endly smile or a sincere handshake. R1 and R2 make R3.
R3 – Revenue - Without this final third “R,” companies would not be
R3 – Revenue - Without this final third “R,” companies would not be
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
in business. Revenue is the ultimate desired end result. When revenue grows, both the company and employees transition beyo
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
d surviving and transform into a thriving, high performance, results driven team where everyone shares a laser focus. Succes
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
sful companies and individuals actively work the 3-R’s every day regardless of their yearly achievements. Complacency for th
.
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
se individuals is not an acceptable attitude!
If your goal is to reach that next level of success, then maybe the first ste
If your goal is to reach that next level of success, then maybe the first ste
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
is ask yourself, do you know your 3-R’s? And the second step is to begin to construct a plan to help you improve your 3-R’s
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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