Subjects - Business

Outsourcing has received a bad reputation in the United States. But one must take care not to eliminate any consideration of outsourcing because of possible outrage against it. Most companies outsource and do it wit

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

hout taking jobs away from Americans and giving them to foreigners (the contested type of outsourcing). Outsourcing is commonly practiced so that a company can concentrate on what it does best, while letting experts

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

Examples of combination products may in

take care of needed business tasks not related to this company’s primary purpose.

For example, a company that manufactures light bulbs has experts available in electronics, filaments and glass, light bulb specificati

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

ns and standards and so forth. Since they don’t need a lawyer all year, they hire one from a law firm on those occasions they need legal assistance. In other words, they “outsource” their legal needs. The law firm

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

exists, at least in part, to serve the needs of companies that either don’t need to hire their own full-time lawyers or wish to outsource their legal activities for efficiency purposes. The law firm has the experienc

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

Combination pro

e, staff and knowledge to solve the company’s legal issues in a more quick and efficient way than the company would have been able to do itself. After all, its expertise is in light bulbs, not the law.

One area wher

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

companies both large and small commonly outsource large areas of responsibility is Human Resources. Although every hiring company has a Human Resources function, it is usually only the tip of the iceberg with regard

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

to how much Human Resources work is really being done on behalf of that company.

Even our largest firms, who may have the wherewithal to hire a full staff, recognize the value of outsourcing. Most of them will outs

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

ource certain Human Resources functions such as payroll. In this case, the payroll company keeps a database of the company’s employees with all the necessary data to process their payroll, such as withholding rates,

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

ocial security number and other deductions. Each pay period the company forwards relevant period information to the payroll company. This would consist of hours worked, vacation or sick time used, new or terminated

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

employees, etc. The payroll company produces the checks or deposits for each employee. It takes care of the tax deposits for the company and sending any other deductions from payroll to the proper recipients. It th

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

Following aspects would a

en sends W-2’s to employees at the end of the calendar year and provides the company with various types of reporting.

This kind of work takes a bit of processing power and would require each individual company to inv

dd to the challenges in developing combination products:

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

st in expensive software to track everything properly and legally. It’s more efficient for a 3rd party to do it for many companies. Outsourcing reduces overall costs and increases efficiency and accuracy.

Another H

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

uman Resources function that is often outsourced is hiring. This can be done in different levels. For example, one company may hire an employment agency to do the initial screening of candidates just to make sure ev

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

eryone the company sees meets a minimal set of requirements. The company will take the next steps of interviewing and choosing the new employee. In other cases a company could hire the employment agency to do the en

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

ire process and present them with their new employee. This is rare for permanent positions, but is often used for temporary employees.

The initial screenings are the most time consuming part of the employment proces

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

Professional from academic institutions, pharmaceutical industries, health care indust

s. Depending on the job, there could be hundreds or even thousands of resumes received for a particular job. Going through these to ascertain the candidate meets the minimum requirements for the job is not difficult

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

work, but is time consuming and tedious. Rather than spend its time and money on this function, the company recognizes that paying others to do it is the financially sound thing to do. At that earliest stage of the

.

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

process, the outsourcing firm needs only to know about the company and the needs for this position and, with their interviewing expertise, can choose excellent candidates without first hand knowledge of the company or

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

Companies that provide selfless information through particip

working environment.

Outsourcing is a necessary component of a profitable company’s business plan. By choosing wisely, a company can be more profitable and efficient by letting other companies take some of the load

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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