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Different projects have different characteristic. All of us would like to work on projects that will in most cases be successful.

For progress and development in business, it is im

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

portant to re-evaluate the projects you are pursuing and refine the business direction you are moving in keeping in mind the resources at your disposal and the goals you have set fo

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

Examples of combination products may in

a particular project. When running our own business, also, we try to choose the projects that suit our lifestyle and personal goals and the ones that best fit the changing world wi

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

h respect to the technology and environment.

One would like to choose the projects that have high probability of success and reduce the risk exposure for you. The projects that hav

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

more likelihood of success have the following characteristics:

· Once the product is created, the same product can be sold over and over again very few ongoing changes in the prod

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

Combination pro

ct are required

· The product has use for customers who have the ability and would like to spend money for the product

· The product selling process can be automated

· Little or

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

no inventory requirements, very few employees, no office overhead needed to run project

· No presence of partnerships, no revenue splits, no requirement of dependence on others for

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

legal or financial requirements

· Minimal project start-up cost and very low overheads and only basic ongoing management requirements after project has taken off

· Breakeven point

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

can be achieved after only a few sales are completed

· Very few or no downside risks are there, for example no foreseeable legal or moral problems are there

All the above characte

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

istics will not be found in many projects, but more the number of success characteristics that a project has higher are the chances of success in that project, and reduction of risk

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

exposure. Along with the project characteristics, one also needs to analyze ones own capability in terms of ones skill sets and the resource availability. A few of the projects tha

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

Following aspects would a

t have the above characteristics are given below.

Subscription Website related

Offer information and content related products for example articles, tutorials, tips on various sub

dd to the challenges in developing combination products:

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

ects etc

Offer applications on taps, for example with a click on your subscription website you could allow them to download some custom made applications or other applications tha

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

are not easily available Producing/Marketing DVDs

How to DVDs and Videos for various complicated products so that people can get a demo kind of experience and have a tutorial a

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

hand, all the time.

licensing out the sale of the how-to DVDs and videos, for certain products, that are created in house, to somebody else Conducting Trainings

Conducting tra

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

ning workshops on use of various software applications or web applications

Producing videos of these training workshops and selling them or licensing the sales process to an outs

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

Professional from academic institutions, pharmaceutical industries, health care indust

ide vendor Creating Software applications and Tools

Creating custom made software and tools (add ons to existing technologies) to be sold to tech customers who may need them. Als

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

licensing the sale of these tools and software applications created in house to an outside party.

Creating successful business applications like subscription websites and giving

.

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

he ownership rights to another person for a price.

A number of project ideas that may have the characteristics of low risk exposure, high returns, short breakeven points are there

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

Companies that provide selfless information through particip

but everyone can not succeed at all the ideas. You have to figure out which business idea will suit your aptitude and what skill sets do you possess to run that particular business

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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