Main Subject - Business

The ‘Spirit of Service’ Award is given to uniquely deserving teams and individuals w

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

ho go way beyond the call of duty to serve, aid or comfort the heart of another huma

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

Examples of combination products may in

n being.

One worthy winner is an unnamed night nurse in the maternity ward of a nea

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

rby hospital.

A new father wrote to me with this report:

‘My experience at the hos

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

pital was very positive. I was staying over with my wife after the delivery. One nig

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

Combination pro

ht I had a headache (maybe from the lack of sleep and being a first-time parent). I

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

asked one of the staff for a pain reliever. She gave me a neck rubdown for a few min

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

utes instead! That really made me feel better, and no need for medication. I was imp

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

ressed that the staff went out of her way to satisfy a “customer”, even when I wasn’

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

t the baby or the mother. Is that good customer service or what?’

You bet it is! Th

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

ree key characteristics of an ‘UP Your Service Mindset’ are: abundant generosity, ge

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

Following aspects would a

nuine compassion and seeing the world from your customer’s point of view. Whoever sh

dd to the challenges in developing combination products:

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

e is, this night nurse at the hospital clearly demonstrated all three.

Key Le

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

arning Point
-----------------------------------------------------------------

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

---------------
To offer the spirit of service, look beyond your customer’s req

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

uest to identify their true concerns. What you can offer may be different, and more

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

Professional from academic institutions, pharmaceutical industries, health care indust

effective, than what they have requested. Listen for unspoken needs, not just spoken

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

words.

Action Steps
--------------------------------------------------

.

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

------------------------------
Extend your care beyond the normal course of act

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

Companies that provide selfless information through particip

ion. Serve your customers, and those they love, the way you would love to be served.

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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