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Working Smarter – we’re forever being told to work smarter.

Yet – so many people have no idea

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

how to stop working harder and how to start working smarter.

Here is a simple concept to hel

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

Examples of combination products may in

p you work smarter:

A fisherman goes out to sea and throws out his line.
He waits for a

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

while to catch a fish.
Eventually a fish bites, he pulls the fish out of the water and

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

throws his line back in again.
Then he waits for a while to catch a fish.
Eventuall

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

Combination pro

y…
And so it carries on.

Another fisherman goes out to sea and follows a different s

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

trategy.
He spends time looking for a school of fish.
When he eventually finds a sch

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

ool of fish, he throws out a net and pulls in hundreds of fish.

Which fisherman do you th

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

ink is more successful?

Most likely, the one who goes after the school of fish.

When

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

you think about your business - where are your schools of fish?
Where do a lot of people

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

who make use of your service get together?

A few weeks ago I met a wedding photographer

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

Following aspects would a

at a networking event.
He admitted that at networking events he did pick up some business

dd to the challenges in developing combination products:

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

here and there, but it wasn’t particularly successful (well, of course not – he was a fisherm

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

an throwing out a line and waiting to get lucky.)

However, if he made an effort at getting to

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

know 50 florists really well.
If he got to know wedding planners really well.
If

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

he got to know wedding shops really well…

By taking the same hours that he would have spe

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt at a networking event and rather spend that time working on/ with his schools of fish – he

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

is much more likely to get his effort rewarded in a much better way.

Stop wasting your time –

.

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

make sure that you are in fact chasing after schools of fish as opposed to single fish.

You’

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

Companies that provide selfless information through particip

ll turn your business and your cash in-flow around in no time.
Guaranteed.

Happy Fishing

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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Non-profits searching for potential funders are often elated to find what seems to be a perfect fit, and then equally disappointed to learn that the Foundation does not accept unsolicited proposals. Here is how to introduce your program to the Foundation and get invited to submit a proposal!

Your customers directly impact your business each time they decide to spend money with you or not. Your customers affect your livelihood, the success of your business, and the future of its existence. Are you aware that there could be others influencing your business indirectly? There are those in your community or those somehow related to your line of work that have the capability to influence your potential customers and their buying power. For example, ponder the pharmaceutical drug industry. Are the drug companies themselves solely responsible for the choices that the general public makes when filling prescriptions? Of course not. The physicians writing the prescriptions are the ones recommending certain medications over others. There may exist two or more medications very similar in nature, maybe some even generic. Pharmaceutical representatives know this and take the issue of influence very seriously. They spend lots of time, energy, and money, giving doctors promotional products, gifts, and meals.

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