Main Subject - Business

Strategic plans have many elements and provide numerous opportunities to remain a

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

head of current and future obstacles and not to mention the competition. Executable str

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

Examples of combination products may in

ategic plans have the ability to quickly make course corrections given that the plan is

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

truly embraced by the entire organization.

Three months after 9/11, I spoke to over 100

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

business owners at a local chamber. I asked with a show of hands how many had suffered

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

Combination pro

negative economic impact from that tragic event? A quick glance of the room revealed th

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

at 9/11 had negatively affected 99% of those within the room. Then I asked a second ques

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

tion that revealed far more. How many of you have revisited your strategic plans to make

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

the necessary course corrections to overcome this unforeseen obstacle? Only five hands

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

were raised and two of them were my clients.

As an executive business coach, I was not

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

surprised by the responses. Many small business do not have a plan and if so, they lik

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

Following aspects would a

e their bigger corporate cousins leave it on the shelf or in a drawer. The 9/11 tragedy

dd to the challenges in developing combination products:

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

to the current rising and unstable fuel prices are both examples of unexpected obstacle

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

s.

When strategic plans are reviewed on a weekly basis by the executive leadership team

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

and are totally embraced from the top down, making course corrections is not as difficu

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

lt because everyone understands the need for changing the course even by just a few degr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ees to a full left or right turn.

Ignoring unexpected obstacles is just plain foolis

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

h, negative attitudes.

So, take the time to revisit your plan in the next 48 hours

.

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

and make those course corrections where necessary.

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

Companies that provide selfless information through particip

http://EzineArticles.com/?id=587277">7 Top Tips on How to Execute Your Strategic Plan

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Your opportunity to build a stellar client relationship starts with managing the gap between your perception of how things are going and your client's. Begin the process here . . .

Employee opinion is one of the most powerful resources available to human resource professionals. But what are the best methods for harnessing those opinions?

Referral programs are a great way to motivate your clients and contacts to send business your way. Offering service credits is a typical example of an incentive provided by a referral program.

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Main Subject - Executable Strategic Plan Provides for Quick Course Corrections

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