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John F. Kennedy once said, "Change is the law of life. And those who look only to the past or present are certain to miss the future."

Every day, in hundreds of change situations happe

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

ning in your workplace, the actions of leaders at all levels are risking the promotion of atrophy. This is simply because many managers are ill-prepared to address the changing landscap

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

Examples of combination products may in

of the business. Just as change then is a law of life, so it is with business.

Issues Compounding Change

In and of itself, change is prevalent in your organization. Compounding

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

this are the changing demographics of the workforce on top of issues such as management of strategies for new revenue growth, planned culture shifts and initiatives to contain costs.

I

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

agine the impact to your organization if your managers ignored these issues?

Typically, your environment begins to look like this: rumors, backbiting, lack of focus, conflict, emp

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

Combination pro

loyee anxiety, lack of energy in service to internal and external customers and a breakdown of trust between managers and employees.

Can your organization sustain a competitive advanta

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

e under this scenario? Probably not.

Building Change Managers

It is not enough today that people are promoted from the floor or enter management without understanding the impact

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

of change. Change-ready managers are respected and effective, are able to motive others to be receptive to change and build collaborative environments.

The fact is that people don't le

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

ve companies; they leave bad bosses who are ineffective and not respected. They can't retain employees and they certainly can't motivate the ones who stay. A company can espouse family-

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

friendly benefits and have great pay and benefits, but also have managers who are poisoning the well because they simply don't know how to manage the change.

Supporting and Motivating

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

hange

One of the main conditions for the support of change is the degree of motivation among individuals. During the quality movement by W. Edwards Deming, a lot was discovered ab

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

Following aspects would a

ut how individuals either hold on to the status quo or embrace taking the road to change.

Managers who understand the distractions and emotions of their team members in association wit

dd to the challenges in developing combination products:

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

h change will be better prepared to support and lead them through it. The right training for managers gives them the tools to first understand the change, interpret it and then facilita

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

e the acceptance of the new way vs. the old.

Change-ready managers will communicate more effectively with their employees, encourage participation and empower them to be able to accept

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

change.

Training Managers to Become Change-Ready

As in life, the law of change for business is constant. That's never been truer than it is today. Implementing a training progra

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

to make your managers change-ready will not only make them great bosses, but it will also build teams of greatly- empowered employees who are ready for change. Vital Learning's Support

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing Change program will empower your leaders and first-line managers to:

Understand why change happens, how people react to it and how they need to be supported through the struggle. I

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

volve team members in change initiatives by promoting their understanding and ownership of change and its benefits. Plan for individuals or work group sessions to support the change pro

.

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

cess and reinforce personal and organizational goals. See your local training professional today to get you started building for today and tomorrow.

Quote for the Week

"Without ch

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

Companies that provide selfless information through particip

nge there is no innovation, creativity, or incentive for improvement. Those who initiate change will have a better opportunity to manage the change that is inevitable". - William Pollar

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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