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I continue to be amazed at the amount of misinformation and the number of myths that exist about strategic thinking

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

and planning. During my entire career, I have heard business owners, senior executives and not-for-profit board memb

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

Examples of combination products may in

rs and executive directors utter “mythical” statements about strategic thinking and planning. And I have observed 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.

t these same people truly believe that these myths are reality.

My purpose in writing this article is to share what

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

I believe are the 5 biggest myths and also provide some insights into what I believe are the 5 biggest “realities” o

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

Combination pro

strategic thinking and planning.

The #1 Myth: “Our company (organization) does not need a strategic plan.”

The #1

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

Reality: Every company and organization needs to develop strategic thinking and planning to guide its actions, espec

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

ally in chaotic times.

The #2 Myth: “Strategic planning takes too much time and we must use our time to do our “rea

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

” work.”

The #2 Reality: By engaging in strategic thinking and planning, time will be saved and time will be used m

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

re efficiently and effectively. The effort will provide a system of accountability and evaluation of a company’s or

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

rganization’s effectiveness.

The #3 Myth: “A strategic plan is confidential.”

The #3 Reality: A copy of the strate

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

Following aspects would a

gic plan, which in my model includes vision and mission statements, a list of core values or guiding principles and

dd to the challenges in developing combination products:

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

ists of short term (less than 1 year) and long term (beyond 1 year) goals, MUST be presented and given to ALL employ

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

es.

The #4 Myth: “Strategic thinking & planning are events that only happen at retreats.”

The #4 Reality: Strategi

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

thinking and planning are processes and need to be continuous.

The #5 Myth: “Our company (organization) can do eve

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

ything on our own without any help in strategic thinking and planning.

The #5 Reality: “At best, it is extremely ch

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

Professional from academic institutions, pharmaceutical industries, health care indust

llenging and at worst is impossible to facilitate and participate in the same meeting. A trained facilitator is a ve

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

y valuable asset and will resist the temptations to enter into the detailed tactical problem solving and go “off tra

.

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

k” of the real purpose of the meeting.

Are you a believer in one or more about how to clear up the myths and get to

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

Companies that provide selfless information through particip

the reality of the benefits of strategic thinking and planning to grow your business. Or do you accept the realities

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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