Advice You - Business

When you embark on the journey of organizational change you will undoubtedly encounter resistance. It is the inevitable friction between where you want to go and where you are. It is the result of many things but

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

one thing is for sure, if you don’t deal with it … it will deal with you. Resistance to change comes for many reasons but falls into one of four categories.

1. Genuine interest.
2. Genuine interest on stero

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

Examples of combination products may in

ids.
3. Guerilla resistance.
4. The Gandhi Syndrome.

Let’s take a more detailed look at each type of resistance and what you can do about it.

1. Genuine interest …

When any change initiative is announ

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

ced, from a new sales program to a full blown system implementation, many people in the organization will express genuine concern based on their very real interest in your company. Resistance like this is healthy

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

nd should be encouraged early in the change initiative. You address resistance of this type by doing one or all of the following.

a. Address known concerns in your initial communications.
b. Be sensitive in

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

Combination pro

your meetings and gather concerns and feedback and address what you can in the meeting, in more difficult questions address with the individual privately.
c. Seek out key people to use as a sounding board and

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

privately discuss their concerns.

Resistance driven by genuine concerns is healthy and to be expected. It is important to address these concerns or they will go underground and show up at the next level.

2. Gen

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

uine interest on steroids …

A short while after your initiative kicks off you will find resistance picking up. Much of the resistance will be genuine but much stronger. This is because you didn’t address those ve

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

y real concerns on rollout. Resistance not dealt with gets stronger each and every day. You address genuine concerns on steroids in the following manner.

a. Make sure you know the particular individuals who are r

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

esisting and take them aside privately to discuss their concerns.
b. Make sure you understand whether these individuals have a following and take time to separate real and imagined concerns.
c. Be firm a

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

nd where appropriate, address their concerns but make it clear the project is moving forward and you need their support. It is also important to outline (if appropriate) the consequences of a lack of support.

3.

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

Following aspects would a

Guerilla resistance …

Guerilla resistance is exactly what you think it is. It borrows its name from freedom fighters everywhere. It is resistance gone underground and behind your back. It happens on every change

dd to the challenges in developing combination products:

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

roject. It is driven by either genuine resisters on steroids who believe you aren’t genuine in your efforts or by troublemakers who need the attention. Resistance of this type must be dealt with swiftly and firmly

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

in one or more of the following ways.

a. Take them aside privately, seek to understand their concerns and more importantly their motives and discuss what they see as the end state of their actions.
b. Expla

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

in to them why you are doing what you are doing in clear and uncertain terms.
c. Make it clear the consequences of their continued behavior and put it in writing for immediate follow up.

4. The Gandhi Syndro

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

me …

Many decades ago, without holding any position, Gandhi brought down the British empire without firing a single shot. Resisters practicing the Gandhi Syndrome will bring your project to its knees if they aren

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

Professional from academic institutions, pharmaceutical industries, health care indust

t deal with quickly. People practicing the Gandhi Syndrome do not have pure motives, they simply, for whatever their reasons, feel a need to derail the project. Deal with them in one or more of the following ways.

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

a. Make sure you have done your homework on their underhanded deeds and line up support for action in the organization.
b. Confront them with the evidence, do your due diligence and stand your ground.

.

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

c. Let them know their actions must change immediately or the consequence is termination of employment.

Resistance to change on any initiative is very real. Eighty percent of resisters will Fall into one of the

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

Companies that provide selfless information through particip

top two categories. Ten to fifteen percent will fall into category three and the balance in category four. Plan for it and deal with it immediately or you’ll be like the old commercial … pay me now or pay me later

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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