Useful Advices - Business

Strategic plans can be found on desks, in desks and on bookshelves from the small business to the Fortune 100 firms. Many

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

companies spend thousands of dollars in constructing strategic plans however the business results of those expensive 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

s are less than stellar.

One of the reasons for this disconnect between planning and execution might be because of the l

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

ack of a proven goal setting process. Planning goals, setting goals and achieving goals are necessary activities for any

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

organization that wishes to survive and thrive in today's highly competitive business results driven world.

If we travel

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

Combination pro

back in time to our earliest educational experiences, we would recognize that the majority of employees have had no train

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

ing on how to plan, to set and to achieve goals. Yet, these same employees are expected to secure the desired business r

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

sults. From my perspective as a business consultant and executive coach, these individuals have been set up to fail.

Wh

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

n a proven and sustainable goal achievement process is adopted, everyone within the organization from the highest levels

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

of management to the frontline employees must be trained as well as developed to use this process. This uniformity of be

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

avior creates a common ground for future communications as well as making changes.

The goal achievement process must als

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

Following aspects would a

include specific criteria so that consistency of achievement is increased. Many are familiar with the SMART criteria

<

dd to the challenges in developing combination products:

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

ul>

Specific

Measurable

Attainable

Realistically set high

Target date

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

/ul>

However, if this criteria was truly effective, consistent goal achievement would be within everyone’s grasp. Unfor

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

unately, more people still set goals than actually achieve them.

To help my business coaching clients, I have added 3 ad

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

ditional criteria.

Written – Goals must be committed to writing for greater clarity.
Aligned – Goals

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

Professional from academic institutions, pharmaceutical industries, health care indust

must be aligned to the strategic plan.

Yours – Goals must be yours.

From my clients’ experiences w

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

en the WAY SMART criteria are applied, there is an increase in actual goal achievement. If you truly wish to overcome the

.

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

obstacle of execution within your strategic plan, then take the time to adopt a proven goal setting process where your d

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

Companies that provide selfless information through particip

eams can be turned into reality.

P.S. Read all 7 tips

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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When starting an online business people don’t realize that an online business and an offline business are very similar.

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