Advice You - Business

Many industry sub-sectors make a habit of outsourcing their operat

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

ional needs. In aviation it is amazing the amount of outsourcing,

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

Examples of combination products may in

hich takes place. It makes sense in a way to outsource non-core op

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

erational needs to other companies, such as aircraft washing.

For

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

over 27-years my company; AircraftWashguys.com existed for the mos

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

Combination pro

part in servicing these aviation businesses from Corporate Aircra

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

ft Departments, Flying Clubs, Airlines and Fixed Based Operators.

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

hy, because a specialty niche service based business like an aircr

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

aft washing service can wash these aircraft more efficiently and f

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

ster.

Additionally we now know that with unemployment so low that

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

hiring peripheral staff such as in-house aircraft washing employee

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

Following aspects would a

s. It makes sense also for many other reasons. For instance consid

dd to the challenges in developing combination products:

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

r a Fixed Based Operation or FBO at an airport and their insurance

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

costs. But insurance is only one add-on cost as you expand operat

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

ons to be considered

Each time they add a division in their compa

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

ny, such as Avionics, Flight School, Fuel Sales, Aircraft Rental,

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

Professional from academic institutions, pharmaceutical industries, health care indust

ircraft Sales or Charter Service the costs of insurance go up and

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

hey need additional riders on the liability policies. Outsourcing

.

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

of services such as aircraft washing for their own aircraft, lease

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

Companies that provide selfless information through particip

acks or customers therefore makes sense. Consider all this in 2006

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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