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As more and more people start or consider starting their own business, it is important that they understand th

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

e core steps that are required to launch successful ventures. These steps include spotting, assessing, selecti

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

Examples of combination products may in

ng and executing upon opportunities.

Spotting Opportunities

The first step to entrepreneurship is identifyin

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

opportunities. The entrepreneur must be able to spot an unmet need. Oftentimes this need is seen through an 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

nefficiency in the market – something that doesn’t work quite the way the entrepreneur would like it to. As a

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

Combination pro

result, the entrepreneur figures out a potential solution and the opportunity is born.

Assessing Opportunitie

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

Many entrepreneurs keep a journal that details the myriad opportunities they come across each day. While it

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

takes a creative skill set to identify opportunities, it takes an analytical skill set to assess them. Each op

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

portunity should be assessed to, among others, determine its likelihood of success and the financial and human

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

resources required to execute upon it.

Selecting Opportunities

One of the biggest risks in selecting the wro

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

ng opportunity is opportunity cost; that is, the cost of having to forego another opportunity which may have b

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

Following aspects would a

een wildly successful. Entrepreneurs should assess their potential opportunities and come to a firm decision r

dd to the challenges in developing combination products:

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

garding which one to execute upon. Once selected, the entrepreneur cannot second guess themselves. To do so wo

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

uld lessen their focus and drive towards the selected opportunity, both of which are critical in achieving suc

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

cess.

Executing Upon Opportunities

Execution, or the ability to generate the most value out of an opportunit

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

, requires a unique combination of creativity, passion, persistence, focus, responsibility, intelligence, plan

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

Professional from academic institutions, pharmaceutical industries, health care indust

ning and energy. The entrepreneur needs to know what tasks must be accomplished and be the main driver in seei

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

ng that these tasks are completed in an appropriate manner.

Understanding the four steps to entrepreneurship

.

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

nables entrepreneurs to better understand the path that they are embarking upon. It is a path filled with pote

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

Companies that provide selfless information through particip

ntial pitfalls, but also filled with tremendous excitement, satisfaction and potential to build enormous value

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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Since Theodore Maiman invented the first functional laser or LASER (Light Amplification by Stimulated Emission of Radiation) in 1960, this device, which generates a strong, highly concentrated beam of single-wavelength light, has found several uses in different industries and in various fields including medicine, consumer electronics and information technology.

While every business has, or should have a business card, often it is neglected as a part of an overall strategy. If you take the time to devise even a simple marketing, public relations, or sales strategy, your business card should be an integral part of your plan.

Congratulations! You've just been appointed to your new job. Now the real work begins. It is important from the beginning to convince your new employers that, in selecting you, they have made the right choice.

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