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It all started a week ago. I was driving home from another long, waste-of-time sales meeting, at the office, when I noticed a strange sensation in my mouth. It began as a slight annoying th

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

robbing. Being the macho-type guy I was, I tried to ignore it while getting through the following day. But it persisted and eventually commanded my full attention. So, days later, when I wo

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

Examples of combination products may in

ke up and decided that the entire national armed forces had decided to conduct an all-out training exercise in my mouth with live ammo and bombs, it was time to focus on the real problem.

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

I hate dentists. More precisely, I hate having them peer at me while hovering with an assortment of evil-looking, stainless-steel instruments of mass destruction. With that in mind, I put o

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

ff the inevitable until the pain had reached a 20 on a scale of 1 to 10. My usual dentist had really put me off the last time we connected, by having me wait and hour for a simple exam and

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

Combination pro

then making some crack about me gaining a few pounds since the last visit.

Therefore, I decided I could do better and headed for the phone book. I paged through it looking for anything tha

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 might ease my mind. But almost every ad had the name of the practice in huge letters and some tripe about “Smiles” or “Emergencies.” Well, since I didn’t give a rat’s tail about my smile

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

and figured that every dental issue was some type of emergency, what was up with all these lousy ads?

So I shelved the Yellow Pages and tried a shot of Scotch instead and sucked on some i

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

ce for a while. It calmed me down a bit, though I doubted it was doing anything in a medicinal fashion. As the liquor began to take effect, within my gentle haze, an aberration appeared. It

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

took the form of a large, yellow book and actually spoke to me. “I feel your pain,” he, or rather, “it” began. The it’s middle opened to reveal a full-page Yellow Page ad. The ad stated, “

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

Immediate Pain Relief – We Keep our Appointments, Guaranteed or Free!”

I don’t know whether it was the second shot of alcohol or not, but I felt better right away. I memorized the phone nu

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

Following aspects would a

mber and looked for my phone. Five minutes later, I was booked and ready to meet my new dental savior. The character had stayed long enough to be satisfied and now waddled out the door. It

dd to the challenges in developing combination products:

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

stopped for a second, waved briefly and said, “Just remember it was Wolley Segap to your rescue,”and, with that, it vanished. The end… or is it?

This little story was designed to serve a p

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

urpose and illustrate the need for effective advertising. So, attention business people: Is your Yellow Page ad doing its job? If not, let this serve as your wake-up call. I’ve witnessed ma

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

ny companies that thought they had an ad that worked, while, in reality, it had a flawed headline, lousy copy, or pathetic artwork. How do I know?

I was a YP rep and consultant for nearly

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

25 years and, prior to that, had my own advertising agency. I also have a degree in marketing. I’ve been designing Yellow Page ads for the past three decades. So I have expertise in YP cre

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation and have advised almost 7000 companies on how to put together the most effective YP ads. If you have a display or in-column ad, regardless of size, color or position, I can tell you i

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

t most probably needs improvement in the headline, artwork, body text, placement, book, or heading. You must understand the ROI or return on investment and learn how to track the results a

.

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 well.

So consider getting some expert advice before you place your next ad. There are many good and inexpensive places to turn, some available on the internet. Make sure the consultant i

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

Companies that provide selfless information through particip

s well qualified with at least 25 years experience. Otherwise, you’ll be wasting your own time and money. Then, hopefully, you wont’ really need Wolley Segap coming to the rescue after all

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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