Advice You - Business

The other day someone asked me what a solo professional was, so I

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

explained this to them and then they asked me a question which m

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

Examples of combination products may in

ade me stop and think a bit. Their question was simple enough and

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

it was indeed a very good one as well; Which industries do you th

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

ink have the most solo professionals. Well after a day or so of c

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

Combination pro

onsidering this let me tell you what I have come up with.

You se

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

it is not necessarily the industry, which has the most solo prof

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

essionals in it, but rather the type of work they do within their

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

industries. The types of people who are solo professionals are i

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

legal, financial, consulting, speaking, writing, training, progr

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

amming and thinking. And what industries are they specializing in

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

Following aspects would a

? Well you will find these types of folks in every industry becau

dd to the challenges in developing combination products:

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

e every industry needs legal professionals, financial professiona

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

ls, consulting professionals and so on.

Currently with labor sup

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

ply tight many superstars of industry sub-sectors just cannot fin

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

the people they need to duplicate their abilities and rather tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

n beating their heads against the wall to try, they simply go it

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

alone. I can tell you this however, generally it is those solo pr

.

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

fessionals who behind the scenes are making it happen and if you

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

Companies that provide selfless information through particip

are working with one or many of them, you are smart cookie indeed

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 - Which Industries have the Most Solo Professionals?

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