Main Subject - Business

The identity statement should allow anyone to understand or recognize your business as you would like them to. Taking this one step further, it should also answer the question – Who Cares? … If yo

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

u are having trouble with your identity statement, ask your spouse, friend or colleague to tell you what they perceive your business to be. This may help you assess if you have been clear in your d

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

Examples of combination products may in

scription of what you do. (Taken from “The Ultimate Guide to Creating a Thriving Business”, Yvonne Weld, 2007).

Simply put, your identity statement does precisely that; conveys to others what exac

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

ly your identity is. Your business name is a start to your identity, but is it really telling others exactly what you do? Your identity statement should not leave any questions in the mind of the p

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

rson hearing it as to who you are and what you do.

There are five qualities to a good Identity Statement: it is memorable; it is purposeful; it identifies the quality of the service or product; it

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

Combination pro

explains who is served and how; and, it answers the question “Who Cares?” In order to develop an effective statement make sure your statement contains all five of these qualities and to top it off,

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

it should be no more than 3 or 4 sentences in length. Sometimes it is hard to be clear and concise within those constraints. Here are a few ideas to get you started:

Memorability

If you identify

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

yourself as simply a car salesman who will really care? You are one of thousands of other car salesmen, so what is it that sets you apart? What could you say that will set you apart and want others

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

to do business with you?

Purposeful

An identity statement needs to stay on task – it is meant solely to get others interested in hearing more. Now is not the time to go on and on about why you ar

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

better than your competition. Instead sum it up in a two or three word phrase that contains a colorful and catchy verb. Keep the other party interested and wanting to hear more. Rather than tellin

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

them exactly what you do, give them a hook; a reason to ask more.

Identifies the Quality

What is it the single most identifiable quality that makes your product or service stand out from others

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

Following aspects would a

offering the exact same product or service? Would you rather deal with an auto mechanic or an award winning auto mechanic?

Explains Who is Served

It is a well known fact that a particular product

dd to the challenges in developing combination products:

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

or service will not be the be all and end all to every consumer out there. Ensure that your identity statement focuses on who you are targeting. Make sure you have explained it so that your ideal c

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

stomer will know you are talking to them.

Who Cares

Perhaps this is the most overlooked aspect to your identity statement. Why should the person reading or hearing your identity statement care? E

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

plain what benefits you provide. Remember to think about this from your customer’s perspective because after all they are the ones we want to becoming interested in hearing more of what we have to

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

ay.

Let’s look at an example of a good identity statement taken from “The Ultimate Guide to Creating a Thriving Business”:

Jack’s Toy Shoppe specializes in unique and one-of-a-kind toys for all a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ges. All toys are custom designed and personally hand built by Jack and his team of toy designers. Toys can be delivered anywhere within Canada or the United States.

Memorability – “unique and one

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

of-a-kind toys”
Purposeful – “unique”, “custom designed” “personally hand built”
Identifies the quality – “all toys are custom designed and personally hand built”
Explains who is ser

.

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 – “Canada and the United States” “toys for all ages”
Who cares – for those in Jack’s target market they have heard enough to be intrigued to ask more questions

Your identity statement will

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

Companies that provide selfless information through particip

be a continual work in progress. Don’t expect to get it right the first time you write it out. Remember that a good identity statement has the flexibility to grow as your business grows and thrives

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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