Advice You - Business

Strategy, leadership, innovation, and marketability…all are crucial to business success; however can your business execute?

Small business owners normally spend countless hours organizing business plans and marketing plans

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

without considering if they can execute the plan. Creating a plan whatever type of plan, should be your game plan to achieve your vision. This requires one of the most important skills of any business-Execution.

What is

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

Examples of combination products may in

execution? In business, it’s exposing reality so that you can act on it. Execution is not just about doing what you say you’re going to do. It involves being realistic about your business in all areas including your own

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

skill sets; it also involves having a ‘business mindset’ so that you can take action, and lastly it involves creating a success team that has execution integrated into their skill set.

So how do you begin incorporating exe

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

ution into your business? Here are 5 areas to start with:

1. Face reality. Getting real about your business is the first step to execution. It sounds simple, but it’s hard for most people in general because we spend a l

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

Combination pro

t of time in denial. Denial is a way to make life easier and comfortable.

For instance, I recently asked one of my clients this question, “How do you plan to hit your monthly targets?” His answer, “By incorporating a str

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

ong marketing strategy.” This answer illustrates that this client was trying to tell me what I wanted to hear instead of dealing with reality-he didn’t know the answer. This is denial. The answer should’ve been, “I don’t

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

know, can you help me figure it out?” This is reality.

2. Do the right things right. Marketing is a great example to demonstrate this point. The goal of marketing is to persuade your target to buy your solution. Marke

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

ing is the right thing to do, but if you do marketing the right way, all it takes is being extremely confident about the solutions you offer and backing it up with a solid business that can execute. Many successful sales h

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

ave been made without spending a dime on direct mail, advertising, networking, and other marketing mediums.

If you learn how to do the right things right; your business will execute consistently.

3. Get rid of your exces

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

baggage. I say excess because we are human and we all have some degree of baggage whether its family challenges or internal challenges. If the baggage is exceeding your emotional capacity, you have excess. Excess baggag

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

Following aspects would a

may include: negative self-talk, intentional fear, procrastination, laziness, and the list can go on.

The excess baggage can take on many forms and it will impede you from executing the vision. To begin peeling off thos

dd to the challenges in developing combination products:

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

e excess layers of baggage, learn the power of focus.

4. Identify your weaknesses. It’s really easy to identify our strengths or what you’re good at, but can you detail the true weaknesses of your business. I’m not talk

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

ng about poor sales, lack of resources, or one that I hear most often-no money. These are not weaknesses, because you don’t have to do much to overcome them. A weakness is more about a lack of aptitude or skill when it com

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

s to business. For example, if you have a lack of strategic direction-it will take some work to turn this weakness into a strength.

Another way to look at it-your competition is preying upon your weaknesses. They know wh

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

at your weaknesses are, do you?

5. Learn the art of simplicity. Instead of thinking for ourselves, we rely on the thinking of others. For example, most of you probably know everything that I’m touching on in this articl

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

Professional from academic institutions, pharmaceutical industries, health care indust

to some degree. I’m really not giving you foreign information-we just aren’t used to trusting our instincts. We feel that the more complex path or complex answer must be right. The simple path or simple answer just can’

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

be, “It can’t be this simple…can it?” How many times have you used this line or heard it from someone else? The next time the answer is yes, it can be that simple.

As you evaluate and manage these 5 areas, execution wil

.

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

l present itself and clarity will take over. Just remember, don’t learn the tricks of the trade, learn the trade; if you do you will execute consistently and build a profitable business with longevity.

© 2005 Effici?, Inc

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

Companies that provide selfless information through particip

, Inc.

NOTE: You’re welcome to “reprint” this article online as long as it remains complete and unaltered (including the “about the author” info at the end), and you send a copy of your reprint to publications@efficio.biz

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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