Advice You - Business

I received an inquiry the other day from an organization that’s inviting me to speak before its staff.

Small problem: they can’t pay me my stand

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

ard fee.

Well, scratch them off them off the list, right?

Wrong.

If I’ve learned anything in my consulting career, it is the wisdom in the phr

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

Examples of combination products may in

se, “Mighty trees come from tiny acorns.” A prospect may seem small, but that’s only what a snapshot will reveal. Look deeper, and you’ll start t

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

detect its potential, which can be phenomenal.

Here are seven things that should be considered before we dismiss a potential deal as being impo

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

sible to make:

(1) What additional forms of compensation can they offer, besides money?

My dad, an astute businessperson and salesman, was very

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

Combination pro

fond of trading goods and services. For instance, the hot, Black Mustang convertible he drove was traded for advertising time on the radio. (His

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

best trade, from my point of view!)

If you can’t do a 100% trade, consider making a deal for part-cash and part-trade. Airlines are often willin

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

to make these arrangements.

(2) Will this experience enable you to penetrate a new market?

Some industries are difficult to break-into. Glamor

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

us movie studios have no problem lining up vendors, and they can be very picky about hiring you, especially if you haven’t worked in "the biz.” S

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

o, that inquiry you get from a tiny, independent studio may be just the credential you need to take you from being an outsider to becoming a chum

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

y insider.

(3) A well-managed start-up may be tomorrow’s mega-firm.

You’re not just a salesperson, a marketer, or a businessperson. You’re inve

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

Following aspects would a

ting in your clients in a way, by deciding to expend effort with them. If you think they are on the upswing, start with them on the ground floor.

dd to the challenges in developing combination products:

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

You’ll take-off, together.

(4) Provide creative financing.

Defer some of your earnings, as ballplayers sometimes do, in order to allow manageme

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

nt to temporarily strengthen its financial condition. There’s a risk, but you can moderate it if you devise a suitable and fair schedule of payme

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

ts.

(5) Cut quantity, but not quality.

Their eyes may be bigger than their wallets, right now, so see if you can pare back the order, a little.

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

The price will become more modest, but you’ll still be able to serve them.

(6) Consider sending them to a struggling competitor.

Why help the c

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

Professional from academic institutions, pharmaceutical industries, health care indust

mpetition? You’ll be taking the high road, and you’ll make two new friends, at once. And who knows, some day, that competitor may return the favo

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

r, or be open to a merger or acquisition overture.

(7) Will I feel better by saying no, or by saying yes?

There is an emotional consequence to

.

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

aking or passing on every deal. I regret having passed on about half of the deals that I thought I shouldn’t do. Some would have had tremendous u

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

Companies that provide selfless information through particip

side potential.

So, the next time you feel that you just have to say no, try your best to say yes, let’s make a deal!

Dr. Gary S. Goodman © 200

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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