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Re-invention; Six Random thoughts “If it ain’t broke don’t fix it”… term often heard at Hurtte’s Texaco 1964 I had just started working as a car wash boy (a strapping ten years old) when I first heard mechanic Von use the term

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 bet you’ve heard it used too. To some extent, there’s a bit of human nature stashed deep in the phrase, too. Unfortunately, in today’s business “things” are breaking daily. Being prepared with better decisions equates to anticipating issues and planning alternatives befor

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

things break. Reinvention takes place when we fix the “broke” without waiting for the “explosion”.

The following are some random thoughts on “breakage”.

What might break? One --Computer Technology continues as a major driver of change. As I sit in my c

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

mfortable chair laptop on my knee, I think about the changes in the technology of creating this article. In 1984 my process for creating this article would have included dictating a draft to my secretary, Sherry. She would have manually typed the manuscript at least three times

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

Finally, I would have dropped the finished copy into the mail at the downtown Post Office. In just a little over twenty years we went from fax, computer, home computer, and floppy drives, to email and laptops with wireless.

How can technology change your business?
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro
What happens if you don’t use it?
How long will it take you to learn it?

Two – Demographic shifts can cause things to break. You may be doing things fine but your customers may be going out of business. Ultimately somebody is going to suff

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

r. Here are a couple of short examples in the demographic business. Sometime in the 1970’s the North American Machine Tool market took an abrupt change. If you were doing a business with one of these companies you might have had some breakage. Think about the shifts in manufa

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

turing demographics as scores of businesses moved off shore.

What kind of long range demographic changes are you anticipating?
What happens if you are not prepared for these shifts?
How long will it take you to adjust if you wait for things to “break”?
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
>

Three – Fashion doesn’t necessarily mean latest in clothing trends. I like to think of these as the cultural trends that affect everything from our shoes to our house and car. Here are a couple of fashions you may have noticed. Granite counter tops in

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

itchens come to mind. A realtor in Bettendorf, Iowa told me, “A granite top in your (gourmet) kitchen will sell you house every time.” The only place I remember with granite tops when I was a kid was the High School cafeteria. Yet, my guess is you can think of a half dozen peo

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

le with newly installed granite top counters.

Are there fashion trends that can cause things to break in your business?
How can you monitor and make best use of the changes in your own area of expertise?
What new positioning would put you at the front of

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

these fashion trends? Four – Competition is a good thing, but even slight changes in competitive landscape can cause things to break. In the industrial contactor and small business world, Home Depot and the like have vastly changed the lay of the land

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

Staples and Office Depot have changed the dynamics of office supply. But these are just a few of the shifts.

What happens if even a small competitive force comes your way?
Are there customers who might be vulnerable to a competitor?

Five
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
rong> – Commoditization will rock your world. The half life of a lot of businesses is getting shorter. Back in 1991 there were dozens of independent movie rental stores. Movies started off renting for 4-5 dollars per day. By the end of the boom times, they were renting for a
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
uck a week. Now www.netflick.com is putting a commodity squeeze on the few remaining brick and motor businesses. Movies are renting for next to nothing. They had things break in that industry. And, the list could go on and on. Computer wholesalers felt their product become
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
ommodity. And to my recollection only a couple actually survived that commodity drop.

Do you know where your products lie in the commodity curve?
Commodity products result in lower gross margin, what effect will an overall lowering of gross margin percentage hav
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
on your products? Six – Supply Chain plans can break. In my career, I saw UPS and FedEx change the lay of the land. In 1978, my employer (a Milwaukee based Electrical Product Manufacturer) had forty warehouses across North America. To put this into
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
a local perspective, the only way a Des Moines customer could get anything next day was counter to counter airfreight (very expensive) or via bus from the Davenport warehouse. This sounds funny by today’s standards but in the late seventies, this was the state of the supply chai
.

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
.

How will future supply chain issues affect your business?
How are your customers and suppliers tied into your own business needs?
A parting thought In 1964 (even 1974, 1984, or 1994) things were different. Business moved at a slower
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ace. Things could “break” and we had plenty of time to “fix them”. Today is different; we need to look for breakdowns in the making. Re-invention, reengineering and constant improvement have become the order of the day. Time spent projecting into the future is 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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