Advice You - Business

Leading change is a tough assignment. People are much more comfortable with the status quo than with disrupting their working lives. It’s nothing personal about you, the change leader; it’s

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

a problem of personal change. The first thing to understand is that there is no such think as organizational change, it is all personal. Organizations are groups of people organized to compl

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

Examples of combination products may in

ete a particular block of work.

So what’s a change leader to do? First understand what I just outlined … that all change is personal. Second, you have to create in your leadership a safe pl

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

ace for your followers. By that I mean they must feel safe talking with you and bringing their true feelings up in an appropriate manner. You must do this in the early stages of your change

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

effort. They must know that they can trust you.

Once you have a personal foundation of your own based on understanding the needs of your followers and you represent a safe place to them, it

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

Combination pro

time to move on with the changes. That starts with a clear reason for the change. There are two questions you must know the answer to before you start convincing others of the merits of you

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

r change journey. Here they are …

1. What problem are you trying to solve? That means with the initiative you are leading what problem will the work you’re about to do solve? Too many times

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

large change projects are started without a clear understanding of this question, let alone the answer. Before you begin to engage people, any number of people from one on up, know the answ

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

er to this question.

2. What will success look like when you do? That means when you have the answer to question one you paint a detailed vivid picture of that answer. With the problem you

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

are going to solve identified this is the step where you outline, before you or anyone else embarks on the change journey, the end result when all the dust settles.

So why do you answer the

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

e two questions before you even start? Because if you don’t you will not be able to effectively engage people in the solution of the problem. If you piled your family in the car and excitedl

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

Following aspects would a

y said, “We’re going to do something different this year for vacation!” and didn’t tell them they were headed for Disneyland they just may not be too happy on the long drive. Now if you told

dd to the challenges in developing combination products:

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

them and shared some brochures along the way and painted a picture your ten hour drive would be a lot more pleasant.

Too many leaders simply think that because they are the leader that eve

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

ryone else should willingly climb on the change bus and live happily ever after. Well, that’s not going to happen in this life or the next. It is up to you to paint a picture of the end resu

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

lt you desire. You need to be doing this from a personal point of view, from a position of trust and do it with clarity.

Now there will be those who don’t get on the bus regardless of how w

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

ll you paint the picture. These are the resisters. You work with them with respect in the beginning; consider their points of view and progress from dealing with their questions in a group t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o talking to them about their concerns privately. But in the end, the bus is leaving and they need to know it.

For the lone stragglers, the proverbial ten percent, you must again make it pe

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

rsonal. They need to understand that the bus is leaving; you hope they’ll be on it, but indeed it is leaving and will arrive at the change destination with or without them. This needs to be

.

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

done with the support of your boss and with respect for the individual. But it must be done. These folks need to know that you are either part of the solution or part of the problem – the ch

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

Companies that provide selfless information through particip

oice is theirs.

To lead change you must engage the people as individuals, honestly and truthfully. You do it by using the steps above, communicating regularly and making the change personal

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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