Advice You - Business

Sunday a business owner I had been chasing years ago when I was starting out approached me. He hadn't hired me back then. Now his busi

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

ness is struggling, near the brink of going under. He is working more than ever and earning less than ever.

Though those who followed

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

Examples of combination products may in

y advice have seen continued increases in their businesses, the only things that have increased for him are his gray hairs and the unne

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

essary stress in his life.

I could easily end this article here with, "I told you so," and then move on to something else...but I won'

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

t...

The reason I'm writing this is because something he asked me on Sunday made my head spin. He smugly asked if I was still involved

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

Combination pro

in the image advertising business.

What?!?

I could feel my head start to tighten. That vein in the center of my forehead that pops ou

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

when I'm angry was throbbing like a high pressure water hose with a kink in it.

Where did I go wrong? What did I ever say or do to ma

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

ke him think I was involved with image advertising? Did he not read any of my newsletters I sent him? Did he not read the sequence of s

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

les letters I sent to him explaining how to increase his sales and eliminate marketing guesswork? Did he not read any of the articles o

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

my site or in my blogs?

Nope.

He assumed image advertising in his own mind, without actually reading anything. And that is why he av

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

ided my follow calls too.

This encounter drove home even deeper for me how important it is to choose very carefully the clients you pu

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

Following aspects would a

rsue. I think it was Dan Kennedy and John Carlton who both said only choose clients who are already doing some form of direct response

dd to the challenges in developing combination products:

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

arketing, regardless of industry.

The ideal client is one who doesn't need me. They can do the work themselves and their businesses ar

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

thriving. The reason they hire outside help is to save time, gain a third-party perspective, and to lighten their load. For them, it

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

isn't a case of not knowing what I do.

Anyhow, I'm glad I had stopped chasing this business owner two years ago. Big waste of time and

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

resources.

Oh, would you believe, though his business is failing, he's still going to continue doing what isn't working, 'because he's

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

Professional from academic institutions, pharmaceutical industries, health care indust

been at it so long it eventually has to pay off'? Talk about stupidity!

I think it was Einstein who said the definition of insanity is

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

doing the same thing over and over again, but expecting to eventually get a different result.

He's insane. But I'm not. I'll never pu

.

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

sue a person or business that isn't already involved in some form of direct response marketing.

If you are in a business that pursues

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

Companies that provide selfless information through particip

lients, even indirectly, I urge you not to chase anyone who doesn't already do for themselves what you do either. You'll lose your mind

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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