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The strategic plan in today's competitive marketplace includes a new tool – the business dashboard. Much l

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

ike the dashboard of a car, this tool provides daily monitoring of the key performance indicators for the business

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

Examples of combination products may in

These key performance indicators keep the business not only going in the right direction, but also staying on th

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 map or the plan for achieving the various business goals for the current trip (mission).

During a recent semi-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

ivate executive coaching sessions with 4 small business owners in non-competing industries, one of the business ow

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

Combination pro

ers, Phylis, who had been in business the longest made the following statement: Now, I understand why 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

dashboard does not include cruise control. This particular business owner had been so involved in working

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

n her interior design business that she had definitely been on cruise control. Now, having completed an executable

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

strategic plan, she realized that implementation of this plan to take her business to the next level does not incl

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

ude cruise control.

With many business owners, including these 4 small business owners, spending most if n

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

t all of their time working in the business instead of ON the business, the dashboard provides a quick way

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

Following aspects would a

o ascertain whether the business is ON track to achieving its current goals. When business owners or entre

dd to the challenges in developing combination products:

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

preneurs and even senior management become focused on working in the day to day operations of the business, the ke

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

goals within the strategic plan sometimes get lost and performance suffers.

The business dashboard is different

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

or each company, but what is the same is that all five to seven performance indicators reflect the critical succes

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

s factors and will immediately alert the driver whether a business owner or department executive when performance

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

Professional from academic institutions, pharmaceutical industries, health care indust

egins to suffer or is in critical area that requires immediate attention.. Just like the warning light for the fu

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

l gauge, battery or engine, the end result is that instantaneous action needs to be taken or the business may expe

.

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

rience significant performance issues.

If your business has a strategic plan and includes the dashboard, then you

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

Companies that provide selfless information through particip

may wish to heed the words of this very wise businesswoman: Your dashboard does not include cruise control!

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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E-Folder - Why the Business Dashboard in Your Strategic Plan Does Not Include Cruise Control

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