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The profit margin in niche markets can be razor thin, so the solo entrepreneur must work smar

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

t by necessity. This translates into outsourcing work as needed rather than hiring full-time

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

Examples of combination products may in

mployees. Full-time employees are a luxury that the niche marketer cannot afford. Workers' co

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

pensation insurance, health benefits, and payroll taxes only subtract the the bottom line.

M

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

ny solo entrepreneurs capitalize on their talents by finding a niche that wouldn't be profita

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

Combination pro

le for traditional small businesses or large corporations. These small micro businesses form

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

he network that in turn allows other solo entrepreneurs to exploit their respective niches. F

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

r example, if your niche is CD duplication, much of your business may come from other solo en

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

repreneurs around the country. Flip the coin and think globally. You may be able to hire the

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

ervices of a professional in another country for a one-time project that you couldn't hope to

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

do on a full-time basis.

If your niche is competitive, you will want to look for ways to sta

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

Following aspects would a

d out from the crowd. A good way to do this is to give your customers value added services--f

dd to the challenges in developing combination products:

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

eebies. These freebies can be incentives such as bonus CDs or some other physical product. If

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

you're working from home, you may be at the point where your home just isn't set up to make a

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

physical product or do order fulfillment on a larger scale. Nevertheless, providing these se

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

vices can put you in the red. Again, outsourcing is a good solution.

Outsourcing can provide

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

Professional from academic institutions, pharmaceutical industries, health care indust

the glue that makes your business sticky--that quality that turns visitors into cust

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

mers and keeps customers coming back. Although the cost of full-time employees can be elimina

.

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

ed, the need for expertise remains constant. This is where outsourcing can tip the scales and

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

Companies that provide selfless information through particip

make you competitive. With outsourcing, you're no longer a solo entrepreneur. You have people

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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