Advice You - Business

Customers...NO!

We were visiting in Gisborne, an attractive small town near Mel

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

bourne, Australia.

Walking along the main street I saw a small clothing store w

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

Examples of combination products may in

th a very bold sign pasted on the door directly above the doorknob. It read:

CU

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

STOMERS NO… jam donuts, sticky buns, fizzy drinks, mucky boots, cigarettes, ic

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

creams, gooey lollies, water pistols, fairy floss or half-eaten fruit in thi

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

Combination pro

s shop. Thank you.

I understand the need to keep a shop clean, but the largest,

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

loudest and strongest message in the sign is clearly:

CUSTOMERS NO...

In the w

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

indow next to the door was an even larger sign:

UP TO 50% OFF!!

What an odd wa

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

to do business! The first sign scares customers away. The second begs them to c

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

ome back by slashing prices (and profits).

Key Learning Point
-----

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

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

Following aspects would a

Customers form opinions about every aspect of your business: your place, p

dd to the challenges in developing combination products:

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

ople, products, packaging and procedures. Anything not 100% customer friendly is

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

a message that screams (or whispers): `Stay Away!'

Action Steps
---

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

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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

What messages are you sending to your clients? Review your website, app

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

Professional from academic institutions, pharmaceutical industries, health care indust

ication forms, product information, customer service counters, returns procedure

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

s, etc. Actively seek out moments that are unpleasant, inconvenient, problematic

.

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

confusing, offensive or difficult to understand. Then go to work and smooth the

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

Companies that provide selfless information through particip

way. Make sure every point of contact says it loud and clear: CUSTOMERS WELCOME

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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