Main Subject - Business

Moments of truth are all those times when customers experience and evaluate

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

your service. Work hard, do a good job, and customers will come back for mor

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

Examples of combination products may in

.

Moments of impact are those rare moments when someone goes way above the

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

call of duty, stretches the envelope far beyond the stamp, innovates and tak

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

s action in unexpected ways that are valued, appreciated…and remembered.

A

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

Combination pro

client at a seminar handed me this note: ‘Last night, 10 minutes before depa

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

ture at the airport, I found my car and house keys still with me, which mean

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

s my wife would have been locked out of the house. I passed them to the Sing

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

pore Airlines in-flight supervisor and they managed to get the keys to her w

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

ithin the hour!’

This is a great moment of impact. If the airline was only

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

n the business of flying passengers from city to city, they would miss the o

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

Following aspects would a

portunity to impact this customer for life.

A client of Citibank was delaye

dd to the challenges in developing combination products:

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

d for four hours overseas. He called the local Citiphone office at 2:00 am a

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

d asked them to call his wife six hours later…by which time she would be awa

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

ke, but he would be 37,000 feet up in the air. The bankers made the call, an

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

made the impact.

Key Learning Point

Moments of impact do more than just s

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

Professional from academic institutions, pharmaceutical industries, health care indust

urprise your customers: they deepen the relationship, extend goodwill, incre

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

se tolerance of any future problems and build loyalty far into the future.

.

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

Action Steps

The next time your customer needs assistance that’s outside yo

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

Companies that provide selfless information through particip

r normal course of work, make the decision, make the effort – make the impac

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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