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When preparing for the future, credit union CEOs will encounter people who dig in their heels and resist change because they want to keep things

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

exactly how they have been for years. Some of these people will be credit union board members, and some will be in the managerial ranks.

The key

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

Examples of combination products may in

for the CEO looking to make his or her credit union a stronger entity in drastically changing times is to work for a critical mass of buy in.

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.

he best approach, I call the "Compelling Argument" initiative, is a constant drip approach instead of a last minute tidal wave of information app

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

roach. Here is how it works. The greatest reason for change resistance is fear. The three basic fears everyone deals with (to different degrees o

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

Combination pro

f success) are the fear of failure, the fear of rejection and the fear of the unknown.

When you have someone resist strategic changes they are e

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

xpressing fear on a couple of levels. They fear the new direction will fail and they don't want to be on a board or management team that failed.

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

Or they will no longer have the necessary skill set to implement a new strategy; therefore they will eventually be rejected off the board or out

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

of the managerial team because they no longer fit. Or, this new idea is so different than what has been tried previously they are fearful of the

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

unknown of how employees and member will react, accept, and respond to the new direction.

A CEO must always have the best vision for any plannin

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

process to work; therefore, it is the CEOs responsibility to apply a constant drip of information that will educate, prepare, and create the com

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

Following aspects would a

pelling argument why the forthcoming changes are required to make the CEOs vision a reality. At manager's meeting and board meetings the attendee

dd to the challenges in developing combination products:

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

s expect the CEO to offer information; in fact, they are open to hearing it. If you craft your information by sharing a small piece each meeting,

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

by the time the strategic planning changes are finally discussed, the critical mass of people will feel comfortable because they are well-inform

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

ed and understand the full purpose for the change, as well as realize this has been a well-thought out idea and not a knee-jerk reaction.

The fe

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

w people that still have their heels dug into the dirt not wanting to move, will know they have been hearing your compelling arguments all year a

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

Professional from academic institutions, pharmaceutical industries, health care indust

s to why this is necessary and they will lose their thunder of rallying resistance because their compelling arguments as to why not to change wil

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

l pale by comparison.

By the second year, those resistance folks will have prepared a better case, which only help you to be more on your game b

.

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

ecause some of their arguments may be worth listening to and those red flags will force you to create even better information. In the end, everyo

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

Companies that provide selfless information through particip

ne is better informed, more aware of what is going, and contributing more -- which ultimately makes for an even better strategic planning process

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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