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Outsourcing can really be beneficial for a number of reasons. Some companies enjoy benefits such as reduced labor costs, larger workforces, access to industry experts and incre

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

ased flexibility through outsourcing. However, despite the obvious advantages to outsourcing there are some situations when outsourcing is not a good idea. Although there a num

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

Examples of combination products may in

ber of scenarios where outsourcing is a viable business option there are other scenarios where outsourcing is not the best idea. In these situations it is best to keep the work

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

in-house rather than attempting to make an outsourcing situation work out.

When Outsourcing is Too Costly

One of the primary advantages of outsourcing is a cost reduction. I

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

n many cases outsourcing results in reduced labor costs because costs such as social security, health care and workers’ compensation are eliminated. Additionally, the increased

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

Combination pro

efficiency resulting when tasks are outsourced to industry experts can also result in a cost reduction.

Despite these many opportunities for cost reductions, there are some si

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

tuations where outsourcing might be the more expensive alternative and it may also lead to a financial loss instead of a gain. This may include a situation where the cost of ou

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

tsourcing to a highly specialized expert exceeds the budget for the project. Fees for individuals with highly specialized degrees or areas of expertise are often quite expensiv

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

e. Another possible situation is one where finding an individual qualified to complete specialized tasks would be too expensive of a process.

When Outsourcing Causes You to Lo

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

se Control

Even when tasks or projects are outsourced the company responsible for the work likes to continue to manage the project and keep close tabs on the progress of tasks

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

It is important for the company to continue to manage the project even after it has been outsourced because they are the ones who are ultimately responsible for the successful

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

Following aspects would a

completion of the project. Whenever an individual or company wants to deny the company access to project files or documents, outsourcing is a bad idea. The company who has the

dd to the challenges in developing combination products:

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

vested interest in the outcome of the project should never be excluded from participating in making decisions regarding the project.

Before outsourcing a task or project care

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

should be taken to establish criteria for the management of the project. Depending on the length and complexity of the project it may also be wise to schedule regular meetings

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

to provide updates on the progress of the project. During this time the contractor should provide the employer with all documentation necessary to evaluate the progress of the

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

project and verify it is still on track for completion by the established deadline.

When Outsourcing is Not Permitted

Sometimes outsourcing is not a good idea simply because

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

Professional from academic institutions, pharmaceutical industries, health care indust

it is not permitted by contract requirements. Some project contracts may have stipulations stating the work cannot be outsourced to an individual or to another company. Inserti

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

ng such a clause into a contract document is well within the rights of the clients. When they hire a particular company to complete a project or task, they expect all work rela

.

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

ted to the project or task to be completed by members of that company unless they specified otherwise when negotiating the contract. Violating the contract documents in this si

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

Companies that provide selfless information through particip

tuation is not a good idea. The company could be penalized by the client. Penalties may include withholding payment or refusing to award future projects or tasks to the company

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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