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When I first started my marriage and family therapy private practice in 1986, it was considered bad form to advertise

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

your services. It was not considered unethical, just something a “professional” did not do.

That never really made a

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

Examples of combination products may in

whole lot of sense to me.

I think it came from the never was true notion that all you had to do was hang up your shin

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

gle and the clients would flock to your door.

Breaking the rules

So when one of my colleagues and I put an ad

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

in the paper for a teen therapy group we were running, you would have thought we had shot someone. The reaction varied

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

Combination pro

from stunned silence to comments such as “What are you guys, ambulance chasers?”

Well, what made all the flack easie

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 to take, besides the fact I have a fairly thick skin, is that it worked. We tapped into an underserved niche (teens

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 their parents), the practice took off, and I’ve been busy ever since.

Unexpected results

Because I had ru

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

a few adds in the local paper, when it came time to interview an expert, the reporters came to me. For years I had ev

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

erything from one line quotes to full feature interviews in the paper. This was nice, as it upped my perceived “exper

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

t-ability” and brought in many clients.

And then came the mother lode. I was asked to write a weekly mental health co

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

Following aspects would a

lumn for the local paper. This brought in a flood of clients. That would have been great enough in and of itself. Then

dd to the challenges in developing combination products:

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

the parent company of the local paper picked up the column for syndication and began to run it all over the country an

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

d then all over the world.

Almost 20 years later

Here it is almost 20 years later, and at the last local marr

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

iage and family therapy association party, I had people following me out to my car asking questions about how I do wha

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

t I do. The funny thing is that some of these folks asking for tips are some of the same ones that gave me flack years

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

Professional from academic institutions, pharmaceutical industries, health care indust

ago.

I don’t tell you this to impress you. I tell you this to impress upon you the answer to the question in the titl

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

e of this article - “Is it wrong to let others know what you do?”

The answer is a resounding NO! Not only is it accep

.

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

table to let others know what you do, when you have something inside you that can help others, you not only have the

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

Companies that provide selfless information through particip

right to let others know what you offer.

I believe you have the obligation to let others know what you have to offer

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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Strategy of building a successful logo for any business and Logo Design Strategy for logo designers.

There are several ways to determine the value of your inventory and each type of valuation has benefits. The most common type used by small businesses is average cost or weighted average costing. This is based on the average cost of identical units.

The author has spend years training supervisors, generally in manufacturing. With whatever curriculum he used he would add a chapter on adult learning theory. With this as a framework, he believed that trainees are far more receptive to the training as they have some understanding of why and how the program is constructed to benefit there growth. Very rarely do training facilitators take the time to explain the basics of adult learning to class participants. Indeed, if he has limited facilitator experience the facilitator may not even know the basics of adult learning himself.

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