Digg It - Business

Before Christmas I found a display of older candy brands, and some of them made it into my cart. Among other things I picked up Beeman’s Chewing Gum to put in the stockings of several family members.

While visiting my Dad before Christmas, he told me a story about fin

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

ding something at the store and buying all they had. As he told me the story he tossed me a package of Beeman’s. I burst into laughter and told him he would enjoy at least one of the things in his stocking later…

This all happened several weeks ago, and as I write th

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

Examples of combination products may in

is I am chewing Beeman’s Chewing Gum. If you are unfamiliar with Beeman’s it was invented in 1898 to ease heartburn, since it initially contained pepsin. Beeman’s was then a popular chewing gum brand for many decades.

I bought the gum out of nostalgia – the package a

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

one brought a smile to my face and hoped it would for others too. Thankfully, I was right. What I didn’t know at the time of my purchase was that this gum would help me learn something about business, change, and myself.

I’m really not much of a gum chewer. Occasion

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

ally I’ll have a piece of gum if offered, or if I think it would help my breath. What I have noticed is that all the newer gums come in smaller portions but have amazingly long lasting flavor. I always find myself feeling like I’m chewing almost nothing, and having a

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

sore jaw long before the flavor is gone.

Not so with Beeman’s. You don’t chew a piece of Beeman’s, you chew a stick. And while the flavor is excellent at first, it doesn’t last nearly as long. It was this insight that got me thinking…

Making Gum

Imagine a meeting

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

t one of the big chewing gum companies. Someone proclaims, “What we need is more flavor – we need flavor that lasts a long time.” Everyone agrees, then they discuss what the flavor itself should be, and a new gum brand is on the way to market. Everyone would assume th

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

at people would want more and longer lasting flavor.

By these measures gum manufacturers have surely succeeded. But for an occasional chewer like me, I’ll take Beeman’s. I like the feel of a full stick in my mouth instead of a small pebble and I like flavor that seem

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

s to magically wane about the time my jaws start to ache.

At first I chalked up my feelings about this old fashioned gum to nostalgia, but the more I thought about it, the more I thought I had real reasons for my preference. Once I got past nostalgia, I got thinking a

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

out change.

The Flip Side

I spend a good bit of my professional life helping people and organizations think about, learn from, prepare for and manage change. I am a proponent of change, and have many items in my home and office that show I am far from a laggard. I a

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

m interested in willing to try new things.

While I embrace most change and am willing to try new products, sometimes the old products work just as well. Many people swear by 20 Mule Team Borax as a detergent or laundry additive, even though it has been around for over

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

Following aspects would a

100 years. People were shocked when Coca Cola created New Coke, and eventually, Classic Coke was returned to the marketplace.

Finding the Balance

None of this means we shouldn’t continue to innovate in our businesses, or that we as consumers shouldn’t try new produc

dd to the challenges in developing combination products:

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

s. Rather, in our quest for the new solution or product, we shouldn’t forget the older one.

As I thought about all of this for a few days, I kept humming a Merle Haggard song from 1981 called, Are the Good Times Really Over. In the second verse he sings,

I wish Coke

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

was still cola and a joint was a bad place to be.

It was back before Nixon lied to us all on TV.

Before Microwave ovens when a girl could still cook, and still would.

Is the best of the free life behind us now and are the good times really over for good?

Both of th

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

e verses focus on a nostalgic view of the world, and are reinforced by the chorus,

Are we rollin' downhill like a snowball headed for hell?

With no kind of chance for the flag or the liberty bell?

I wish a Ford or a Chevy would still last ten years like they should.

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

Is the best of the free life behind us now and are the good times really over for good?

But the song ends with a revised chorus, with a revised vision of change and the future:

Stop rollin' downhill like a snowball headed for hell.

Standup for the flag, and let's all

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ring the liberty bell.

Let's make a Ford and a Chevy that'll still last ten years like they should...

The best of the free life is still yet to come and the good times ain't over for good.

We can value, learn from and use the products of the past; and still look for

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ward to, try, and create innovative products in the future. These two things don’t have to be contradictory.

The book copyrighted in 2005 isn’t necessarily better than the one written in 1955 (or 1905). Rather than assuming the new is better, read both. The new gum

.

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

s good, but so is Beeman’s.

You can be a champion of change and still like Classic Coke – in fact you can learn much from the existing or popular products of the past and use them as a springboard for the future. After all, Volkswagen made a new Beetle and had a hit an

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

d Ford is making a new Mustang that looks like a 35 year model.

I encourage you to think about your own feelings about change, and what you can learn from the examples I’ve shared with you.

And if you haven’t had a stick of Beeman’s, if you get a chance, give it a 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

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