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Many people believe that everyone sees the world exactly the same way as they do. This is never true and was the source of much turmoil in Dr.

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

Jacob’s office.

When the Job Isn’t Getting Done

“They never seem to get any work done on time, but they complain that they're being underutili

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

Examples of combination products may in

zed.”

Dr. Jacob, a chiropractor, was talking about his office staff.

“I have to do so many things myself that they could do for me, but they d

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

n't. They just don't seem care about what I want. I just don't understand. I pay them well and they need their jobs.”

As Dr. Jacob’s frustra

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

tion increased, he explored the idea that he had hired inappropriate people in the first place. He reflected that if only he could find the pro

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

Combination pro

er leverage he thought he could make them do what he had hired them to do.

Leverage to Dr. Jacob meant the proper combination of rewards and th

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

reats.

Guidelines May Be Necessary

When I asked about what guidelines the staff was given to do their work Dr. Jacob admitted that he let them

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

set up their own procedures with very little input from him. He communicated his expectations very vaguely, because he himself hated to be told

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

what to do.

Dr. Jacob thought if he were “nice” to them, they would like him and work hard to assure the success of the office.

Unclear Expec

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

ations Produce A Schizophrenic Experience for the Boss and His Staff

Dr. Jacob only got angry when they didn't meet his admittedly non-specific

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

performance expectations. When he got frustrated enough, he would insist that his rules be followed; telling his confused and demoralized staf

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

Following aspects would a

f exactly how to do what he expected. They were constantly seesawing between unclear expectations and over-detailed instructions that discounte

dd to the challenges in developing combination products:

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

their intelligence and experience.

Giving Others What You Need For Yourself May NOT Work

Dr. Jacob argued when I suggested that he needed to

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

create clear guidelines for his staff and then leave them alone to do their jobs. He was sure his staff would hate him and quit if he did that,

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

and he firmly believed they would never get any work done without closer supervision.

Dr. Jacob believed that everyone in the world hated struc

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

ture as much as he did.

When I explained that most people need and want structured guidelines in order to feel safe and happy, Dr. Jacob was su

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

Professional from academic institutions, pharmaceutical industries, health care indust

prised. He explained how he had been forced to follow rules for most of his life and cherished his present freedom. He assumed that everybody

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

else felt exactly the same way he did.

Give Your Staff What They Need to Produce Results

He experimented with the idea that some people felt n

.

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

rtured by structure. Warily, he started telling his office manager only the outcomes he wanted including necessary completion times.

The offic

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

Companies that provide selfless information through particip

e manager competently communicated the work requirements, the staff happily met them, and Dr. Jacob was immensely relieved.

©Laurie Weiss, Ph.D

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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