Cases - Business

The term ‘change management’ tends to leave people in the dark, often seeming vague and somewhat

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

mystical. “Does it have something to do with counting pennies,” you might ask? In truth, it h

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

Examples of combination products may in

s little to do with a pocket-full of change and, yet, many similarities.

Change management is m

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

re a leadership skill, than an actual job position or title. It is the ability to take any chan

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

e that affects a company, and to establish a sense of calm and order, out of what many may perce

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

Combination pro

ve as a chaotic situation. The changes can vary, some examples being the introduction of a new

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

oftware program, a change in management, or even something as drastic as relocation. All of the

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

se things can create a sense of confusion and frustration in the workforce. Change management i

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

needed, in order to keep the train on its tracks, and to help employees adjust as quickly as po

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

sible.

Change managers possess the ability to analyze the situation, set up public relations wi

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

h those it affects, and to motivate the workforce towards acceptance of this change. Their purp

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

Following aspects would a

se is to jump right into the mess, grab everyone’s attention and point out a goal, in such a fas

dd to the challenges in developing combination products:

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

ion that it is understandable and will encourage others to reach for it. Developing a team, est

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

blishing individual jobs, and determining a team leader quickly tips the scales, changing chaos

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

into order. While people typically resist change; most embrace it, when shown a route to overco

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

e it.

A valuable asset to any company, change management is essential to making things run smoo

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

Professional from academic institutions, pharmaceutical industries, health care indust

hly. Much like a handful of coins, it begins with the simple ability to sort things out and, wh

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

n used correctly, adds up to money in the bank. While it’s not always easy to turn a chaotic wo

.

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

kforce into a smooth-running operation, change management develops a sense of order and motivate

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

Companies that provide selfless information through particip

the team towards adopting the change. Once that is accomplished, you’ve won the hardest battle

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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