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A small business faces one or the other dilemma because of its limited resources and capital. At particular stages of growth, you may require an extra hand but find

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

that your cost factor is restricting. You might think of hiring a contractor instead. Whether to hire a new employee or an independent contractor is an important b

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

Examples of combination products may in

usiness decision. Both options have their own separate pros and cons.

Hiring an Independent Contractor

1. Advantages

Reduced Overhead: This means reduced costs

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 expenses, payroll, benefits and other overheads. It also reduces stress on covering cost revenue for a new venture.

No Health Benefits: It reduces the high cost

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

s of employee health benefits that are a huge financial burden on small businesses.

Work on Demand: It offers flexibility to the changing work demands of your comp

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

Combination pro

any. You can do without it during periods of slow growth period.

No Training Needed: The contract work force is fully trained and highly specialized.

2. Disadvan

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

tages

Lack of Control: The contractor has the choice of control over the job being executed.

Compensation Rates: These can vary for different projects and depend

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

on the market demand.

Legal Aspects: Classify employees and contractors correctly to avoid liability of employment tax and penalties on account of misclassificatio

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

n of an employee as a contractor. Go by a simple rule of thumb. If you have the right to control the means and methods by which the work is accomplished, then the p

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

erson is an employee. However, if you have right to control the results of the work, then the person is a contractor. Once the understanding of classification is cl

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

ear, then hire either of them after considering their implication on your business contract.

Hiring Employees

1. Advantages:

Loyalty: Employees are more loyal an

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

Following aspects would a

d have greater commitment, resulting in greater productivity. Flexibility. Willingness of the staff to take on additional roles gives you greater flexibility in ru

dd to the challenges in developing combination products:

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

nning the business besides providing learning opportunities for the staff. It is also easier to meet deadlines with committed staff.

2. Disadvantages

Responsibili

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

ty: The burden of supporting an employee through the payroll is greater.

Extra overheads: With an additional work force, besides the additional pay bill, you will

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

require bigger space and equipment, etc.

Becoming a Manager: As the staff grows in number, you spend more time in managing them and your company gets more exposed

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

to worker-related lawsuits.

Some Additional Tips

Whether you decide to hire a contractor or an employee, do remember the following: If the payment of contractor

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

Professional from academic institutions, pharmaceutical industries, health care indust

is more than $600 annual, report the wages on IRS Form1099-MISC to authorities. Sign an agreement putting forth the terms of your business relationship. This shoul

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

d include type of services, time frame, payment details, confidentiality, warranty and other work-related information.

Both employee and contractor hire agreements

.

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

should include the work/product/service copyright laws to guard against misuse or leaking out the proprietary information of your company.

Hiring an employee or a

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

Companies that provide selfless information through particip

n independent contractor has its pros and cons. Exercise the option that is most suited for your business. Do be careful about the legal aspects of both the options

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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