Advice You - Business

I’ve often heard it said that People Don’t Like Change.

But is this really true? If it were true, wouldn’t we still be hunter gatherers, eking out a nomadic existence?

I thi

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

nk this whole idea that people are fundamentally change resistant is a misunderstanding. It comes from dealing with people who feel scared and disempowered. Change managers ca

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

Examples of combination products may in

l them “Low Influence, High Interest” stakeholders. These are the people who are likely to be significantly impacted by a change, but who have no say in what the change is, or

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

how or when it is implemented. People in this position are understandably nervous and tend to be the most vociferous opponents of change.

But, if we were to take a peep into

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

he private lives of these people, we would find that they embrace change every day of their lives. They move house. They get married. They get divorced. They have children. Th

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

Combination pro

y change jobs. They change religion. Some of them even change their gender.

In fact, as far as I can see, being totally change resistant seems like a very uncommon characteri

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

stic amongst human beings.

Most people want new things. Most people want the latest gadgets and the newest deals. People want to move forward and make progress and be up with

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

the times. If this wasn’t the case then surely we wouldn’t have mobile phones and ipods and the Internet.

When we say that People Don’t Like Change, maybe what we really mean

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

is that they don't like our change. And the reason they are scared is because they perceive themselves to be low influence, high interest stakeholders – people with no

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

ontrol and everything to lose.

So what’s the best way to communicate with people in this situation?

One approach is to simply dismiss their concerns and trample roughshod ov

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

r their complaints. This is the approach that many seem to advocate. After all these people are low influence so they don’t matter, right? Tell them that this is how it is to

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

Following aspects would a

be done and if they don’t like it they know where the door is. Tough. That’s business. That’s life.

Personally, I think that this attitude is unproductive and unsustainable.

dd to the challenges in developing combination products:

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

Not only does it breed distrust and disharmony, storing up problems, delays and unnecessary costs for later on, but it also contributes to a general expectation by everybody t

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

at they will be treated when they find themselves in a vulnerable position. It doesn’t matter which stakeholders we are talking about - employees, suppliers, customers, the lo

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

al community – the inevitable lack of trust and cooperation that follows this line of thinking is costly, time-consuming and unpleasant for everyone.

Surely, if people are 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

ling vulnerable and scared, we need to listen to them and allow them to feel heard and respected. It may be that we are unable to accommodate their needs. But people are much

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

Professional from academic institutions, pharmaceutical industries, health care indust

more willing to accept that and take unwelcome news on the chin if they feel heard and respected. And they are much more likely to adapt to the change and continue to perform

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

ell, rather than hitting the highway and leaving us with another position to fill.

This isn’t the macho approach, I know. But it’s a human approach. And it’s sustainable.

Pe

.

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

ple like change. They do it all the time. If people seem change resistant its probably because they feel vulnerable and powerless in the current situation. Listen to them and

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

Companies that provide selfless information through particip

et them feel heard. Then be honest with them and take the trouble to expain why change is necessary.

To quote Stephen Covey, "Seek first to understand, then to be understood.

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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