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A strategic business plan is the scoreboard that records all of the hits, misses and even errors for the current as well as past year. Instead of t

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

he traditional 9 innings for baseball, a strategic plan scoreboard has 12 and includes more than just one competitor. NOTE: A simple strategic pla

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

Examples of combination products may in

definition is who does what by when and its construction is dependent upon the analysis of real time information.

With the New Year just around t

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

e corner, now is the time to review the last 11 months of business hits and misses. Successful firms realize that time must be invest time in w

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

orking on the business instead of just in the business. Here is a 7 day plan that can quickly double your business results in 2007.

Day On

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

Combination pro

: Identify all of your hits. This is all revenue earned through the sales of your products and services.

Day Two: Identify all of your

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

misses. This may include all:

Unsuccessful proposals
Lost sales because not all sales come from proposals
Missed op

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

portunities from not asking for referrals to attending significant events

Failure to execute existing plans

Poor performance in

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

operations including customer service, manufacturing, shipping or management

Day Three: Place a dollar value on all of your mis

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

es and the compare this to your hit list from Day One. NOTE: Depending upon the size of your business and your recording keeping, this may take mo

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

e than one day.

Day Four: Identify the causes of the misses. These misses may be because of poor sales skills to a lacking of planning.

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

Following aspects would a

>Day Five: Determine your desired business results. By constructing W.A.Y. S.M.A.R.T. goals (W-Written, A-Aligned, Y-Yours, S-Specific, M-Measu

dd to the challenges in developing combination products:

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

able, A-Attainable, R-Realistically set high and T-Target date, time driven) in 2007, you can convert past missed opportunities into hits and even

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

omeruns and thereby achieve your desired business results.

Day Six: Build your b

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

usiness dashboard. Managing your key performance indicators on a daily basis is critical to business success. Your business dashboard is very s

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

milar to the one on your car that ensures your vehicle is operating at peak efficiency.

Day Seven: Schedule time to work on your business.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Make a weekly appointment to spend at least 1 hour working on your business. Use this time to review your dashboard and your strategic action plan

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

. Within your strategic plan (Who does What by When) is your marketing plan, sales plan, growth plan and financial plans. Using your dashboard and

.

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

ther tools including organizational assessments, you can quickly monitor your business progress and make any necessary course corrections.

In just

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

Companies that provide selfless information through particip

7 days, you can turn many of those misses from 2006 into hits in 2007 and quickly see your business results double within the first quarter of 2007

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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