I just finished reading a powerful book The Profitable Power of Purpose in which the author Ian Percy (
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
target="_new" href="http://www.IanPercy.com">www.IanPercy.com) states “If your customers were not irri
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
ated, they would not even be your customers.” How true it is! In 1978, I ran an ad in a New York City n
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
wspaper, “Organizing consultant can help you make better use of time and space” and launched a 25+ year 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
iness which is still going strong. Obviously there were, and still are lots of people irritated about thei
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
lack of time and space, because now there is an entire industry devoted to helping people solve that irri
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
ation. A recent TV show said home storage alone is a $3+ billion industry.
I would love to know “What ir
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
ritates you?” Not just about getting organized and being productive, but about life in general? And in t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e interest of providing better service to our customers, what irritates you about the organizing solutions
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
you have found so far? Are they working? What irritates you about Taming the Paper Tiger? (See the end of
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
his article to see how you can contact me).
Our mission is to help you increase your productivity, so you
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
can accomplish your work and enjoy your life. So what is stopping you?
One of the biggest stumbling bloc
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
s to improved productivity is “action!” Action prevents thought and not thinking leads us to do the same
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ld things in the same old way. I remember an old Burma Shave sign on a Nebraska country road: “Choose your
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
rut carefully – you’ll be in it for the next 30 years!” Are you in a rut?
With the “lazy-hazy” days of
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
ummer upon us, take some time for thinking – especially about what it is that irritates you. As Mark Twai
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
put it, “Progress starts with the truth.” I can’t think of a better way for all of us to improve our pr
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ductivity than by admitting the truth about what it is that irritates us, so we can do something to change
.
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
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
m) with your irritations. Who knows – I may know someone or something that can help. I’d love to try
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
