Advice You - Business

Last summer I was sitting on the deck at a gorgeous remote Canadian lake, watching my little dog Macey go NUTS chasing all

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

the squirrels.

She'd chase them at 100 MPH through the bush and UP the tree they would go - fluffy tai

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

Examples of combination products may in

ls flying and they would chatter indignantly from 30 feet above. Then she'd bark at the tree, circle it a few million times before she cam

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

up with her next brilliant strategy.

Macey would sit patiently at the base of the tree for hours- staring upward - not

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

moving a muscle.

I could tell she had TONS OF HOPE that if she JUST kept doing what she was doing - she would catch a squ

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

Combination pro

rrel. (sound familiar?)

What had she missed though?

The squirrels had MOVED to a different
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
ong> tree.

They were now far behind her - looking at her while they took notes on their laptop and commented on how squir
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
els are the superior species!

Are You Barking Up The Wrong SALES Tree?

I see it constantly.

Women business owners and w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
omen in sales complaining about the lack of response they get from their sales and marketing efforts.

How frustra
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
ed they are that clients are not buying fast enough or not spending money at all.

A Diva Comment For You...

You
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
're probably barking up the wrong tree.

If you are trying to ...

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

Following aspects would a
>
Chase customers that don't have a need
Create a market vs tapping into an existing one
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
/ul> ..you are probably feeling a little down and frustrated.

Can YOU See The Forest For The Trees?

OK - hopefully you ha
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ve heard this old saying.

" She can't see the forest for the trees."

What does it mean?

Lack of vision. Lack of focus. F
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
cusing on the smaller parts vs looking at the big picture.

So What's A Girl To Do?

Ask yourself these 3 question
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

Who benefits from my product/service THE MOST? (puh-leassse don't say EVERYONE)

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

Professional from academic institutions, pharmaceutical industries, health care indust
ng>I like working with the MOST?
Where are the MOST of my potential customers "hanging out"? What are t

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

hey ALREADY buying? Macey never did catch a squirrel. (thank goodness!) She didn't quite figure out that when yo

.

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

CHASE SOMETHING it runs away.

What would I have done? (not that this Diva is a Elmer the Fudd "a hunting we will gooooo"

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

Companies that provide selfless information through particip

type of girl)

I would have regularly put a HUGE pile of their favorite nuts and fruit inside a very big cage.

So there

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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Advice You - Are You Barking Up The Wrong SALES Tree?

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