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In the contracting meeting, the department head reviewed my proposal and slid the contract back across the table at me, shaking her head. “Too much,” she said. “I’ll give

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

you 20% less.”

This was more than a decade ago, when I was just starting out in private practice, and one of my first big opportunities was to help a large department work

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

Examples of combination products may in

through a long-standing state of unrest that was getting in the way of operations. Here I was, sitting with the head of the department, attempting to finalize the contract

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

proposal I'd so carefully constructed.

Pleasantly, I explained that I hadn’t deliberately inflated my proposed fees to come in with a highball offer or play negotiating g

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

ames. The proposed fee was a real number based on careful consideration. I further explained that while my hourly rate was not negotiable, perhaps she and I should revisit

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

Combination pro

the scope of the work to be done to see if that could be scaled back to bring the cost down.

She shook her head again, this time rolling her eyes ever so slightly, as tho

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

ugh she couldn’t quite believe she could be talking to such an imbecile. “Everything’s negotiable,” said she, “even hourly fees.”

Now, I had just finished a book cautioni

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

g new consultants not to negotiate their rates (assuming their rates were based on something real, like overhead, income needs, going rates in the field, etc. and not just

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

pulled out of the air) because it became a slippery slope. At a loss for what else to do and fast realizing that my plum of a new contract was slipping from my grasp, I as

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

ked, “Why do you believe that everything’s negotiable?”

She sat back and said, “I don’t. But the head of finance does. He’ll ask me if I bargained you down and got a good

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

deal.”

I stared in disbelief for a moment. Then I picked up my pen, crossed out the proposed fee, and wrote in a new fee about 25% higher than my original one. “Will this

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

Following aspects would a

work?” I asked, sliding the paper back to her.

She pondered my figure for a moment, then said, “Well, I’ll have to offer you 20% less than that. I think I’ve already been

dd to the challenges in developing combination products:

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

clear about that”

“That sounds reasonable,” I said. And we had a deal.

This really did happen. I learned a few important lessons about negotiating that day, ones that ar

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

e often key when I’m helping mediation parties negotiate or helping coach someone for an upcoming negotiation of their own.

I learned that pushing back and being f

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

rm in a position is often not a fruitful strategy. After all, had I refused to consider a new way to look at my fees, I wouldn’t have gotten the contract and I wo

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

uldn’t have this delightful story to tell.

I learned that asking even the simplest question in a real attempt to understand, then really listening to the

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

Professional from academic institutions, pharmaceutical industries, health care indust

answer, can unlock a negotiation.

I learned that knowing someone’s interests can make entirely new solutions visible. Learning that the department head h

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

ad an interest in being able to tell the CFO she had bargained me down helped open up my thinking. And it helped me see her in a different light. No longer was she just u

.

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

nreasonable or stubborn.

And I learned that even the zaniest solutions sometimes work or lead to other ideas that do. Who ever would have dreamed that up

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

Companies that provide selfless information through particip

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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For those wondering when our medical billing review of the EA0 was going to end, this is the final installment of the series covering fields 39 through 55.

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