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Outsourcing has become a very popular alternative for a number of very valid reasons. Outsourcing initially emerged as a way for companies to cut costs by having processes such a

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

s manufacturing and assembly done in overseas locations where costs were much lower. Lower wages and operating costs both contributed to these reduced costs. These lower costs we

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

Examples of combination products may in

e appealing because they greatly improved the profit margins for the companies. However, outsourcing is now gaining in popularity for a variety of other reasons. While cost reduc

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

tion is still a primary advantage, other elements such as access to industry experts, a larger workforce and more flexible options are being embraced as welcomed advantages offer

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

d by outsourcing.

Cost Reductions from Outsourcing

As previously mentioned reducing costs was the original purpose of outsourcing and although outsourcing has since been demons

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

Combination pro

trated to have other significant advantages, cost reduction still remains one of the prime advantages. Companies look to outsource tasks which would be more costly to complete in

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

house. An example of this type of task would be a software related task requiring specialized training. Companies who do not have an on staff employee qualified to complete this

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

task can benefit financially by outsourcing this task.

There may be significant fees required to retain the services of an industry expert on a contractual basis but the efficie

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

cy of this individual will enable him to complete the task much more quickly than it could have been done in-house. If the task were not outsourced an in-house employee would hav

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

e had to complete the task and may have taken significantly longer costing the company more in the long run.

On Call Experts

In the previous section we discussed how having ind

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

stry experts available to complete outsourced tasks can result in a cost savings for the company but having these experts on call also provides the potential for new opportunitie

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

Following aspects would a

s for the company. With experts waiting in the wings to assist, the company is able to go after larger and more specialized types of work. This is important because in doing this

dd to the challenges in developing combination products:

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

the company can find themselves enjoying greater prosperity.

A Larger Workforce

Still another advantage to outsourcing is the benefit of enjoying a larger workforce when necess

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

ary without the hassle of maintaining a larger staff. Through outsourcing companies can bring in additional employees on a contract basis during times of prosperity without worry

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

ng about having to lay them off or keep them utilized when the surge of work begins to wane. This is particularly relevant in industries which enjoy peak seasons as well as off s

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

easons.

Another advantage of having a larger workforce is the ability to generate a larger profit. This is important because smaller companies can find themselves in a position

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

Professional from academic institutions, pharmaceutical industries, health care indust

here they can compete with larger companies for bigger jobs by outsourcing a portion of the workload.

More Flexibility

Finally, more flexibility is another considerable advanta

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

ge to outsourcing work. Even the most well planned projects may suddenly end up behind schedule or under a time crunch due to minor errors, changes in plans or other incidental a

.

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

tivities. Smaller companies who do not have the resources to compensate for these inevitable mishaps may find themselves in serious trouble without the ability to outsource work

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

Companies that provide selfless information through particip

when necessary. These companies can take advantage of outsourcing in times of trouble to help them deal with problems without alienating clients or performing poorly on a project

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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