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Team Building Question:

I’m a manager of a team of 20 people

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

and here is my question. At this year’s survey, the results

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

Examples of combination products may in

how that my team members don’t think their colleagues (from m

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

section and from other sections) often act on their own init

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

ative. I would like to know what are the best ways to encoura

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

Combination pro

e team members to take initiative. Also, are you aware of any

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

road blocks that would prevent employees to take initiative

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

The Team Doc Says…

Definition of scope, boundaries, author

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

ty and autonomy are a must for people to take initiative. Int

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

restingly, during surveys people many times perceive that it’

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

the other person who is not taking enough initiative — never

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

Following aspects would a

themselves. Yet if you received a lot of answers like this o

dd to the challenges in developing combination products:

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

the survey, there may be another underlying problem. You’ll

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

ave to dig to find out what that is.

I recommend that you me

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

t with your team to discuss the results of the survey and ask

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

for their suggestions. That’s one way to “get some initiative

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

Professional from academic institutions, pharmaceutical industries, health care indust

going!” Next meet with each team member individually to disc

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

ss their personal goals and any road blocks they are encounte

.

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

ing.

Open (and often) communication with your team will help

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

Companies that provide selfless information through particip

you identify what may be causing this type of survey response

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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