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There are eight essentials ensuring success in change. They are about changing behavior, attitudes and personal skills - the most challenging and difficult kinds of change to make, but also the most effective and rewarding. We're not dealing with the act of ac

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

quiring something – billions of dollars worth of software,exercise equipment, books, tools, and processes are gathering dust because the people that bought them confused hope with results. They did not follow through with the eight essentials for change – the

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

Examples of combination products may in

goals, actions, persistence and determination to make real differences in individual and organizational behavior.

Essential 1. Realize there are four stages in all change processes. These four stages occur in every successful change initiative - from losing ten

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

pounds, to the adoption of new ways of doing business, to working with a new boss or new owners. Remember them and use them to ensure your success.

Stage One – Enthusiasm – This stage is characterized by high energy, commitment, high expectations and ag

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

gressive goals. This is the stage driven by opportunity and the commitment to meeting aggressive goals.

Stage Two – Frustration – This stage is characterized by a reduction in enthusiasm, frustration with dates and goals missed or delayed, the beginning of fric

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

Combination pro

tion and blaming, the stage where energy declines and initial commitment is questioned.

Stage Three – Renewal – This is the stage where the lessons of the first two stages help create an experience - based set of goals and expectations that lead to success. Thi

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

s is where individual leadership and determination and persistence take center stage and create a renewed energy and commitment.

Stage Four– Success –In this stage success becomes the norm rather than the exception. Goals are being met; the lessons learned from

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 first three stages are being applied; and things are looking good. Celebration of big successes arising from small successes begins. Evaluation of the process for use in future projects occurs.

The remaining 7 Essentials are the personal behaviors, attitude

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

s and skills that will ensure success in any change process or project or initiative. They're not easy – but working to adopt these behaviors, attitudes and personal skills will create success.

Essential 2– Persistence and determination – nothing will support

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

personal and professional change more than the determination to see the process to its successful end – and the persistence to “Press On” through all four stages.

Essential 3 – Choice - while many changes are beyond individual control, we always, and I mean alw

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

ays, have the freedom to choose how to deal with and respond to change. This is the most important belief we can have. To the extent that change is embraced and accepted and seen as being helpful we will prosper – in many ways.

Essential 4 – Set yourself up to

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

Following aspects would a

succeed. Big successes start with a series of small successes. The big picture may be fuzzy, but you can establish goals and expectations for yourself that will lead toward success. In setting up realistic, time measured, specific, results driven goals you can

dd to the challenges in developing combination products:

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

celebrate small successes on the way to big success. It is essential for your own energy and motivation to do that

Essential 5 – Replace judging behavior with evaluation of results. Judging is one of the worst behaviors anyone can practice. Why? Any individua

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

l shares the same behavior profile with no more than 10% to 20% of the population. When we judge others based on behavior, we are judging based on how we would do something, not how others may do it, and we stand the chance of being wrong 80% to 90% of the time

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

Create a results - driven climate to help ensure evaluation is based on performance to goals and expectations.

Essential 6 – Replace assumptions with expectations. Just like judging based on behavior, we will be wrong about 80% to 90% of the time if we assume

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

that others hear things the same way we do, or see them the same way, or interpret them the same way. Create expectations – communicate them – or communicate a clear understanding of them – and clear away a lot of the “fog” that gets in the way of creating the r

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

Professional from academic institutions, pharmaceutical industries, health care indust

esults necessary for success.

Essential 7 – Communicate – communicate – communicate. When you think you have communicated enough, communicate some more. Identify the “universe” of people that you work with; that you work for; that work for you; that support you

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

r work; and whose work you support. Create channels of communication with all of them. The more trust created through communication with that “universe”, the more time becomes available to meet individual and organizational goals..

Essential 8– ACT!!! All the p

.

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

lans and communications and intentions mean nothing without specific, energetic action to meet requirements. Act today – today is all there is – accomplish goals today, and success will follow.

Remember this: The only security anyone has – individually, profes

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

Companies that provide selfless information through particip

sionally or collectively, is in accomplishments. The more change is embraced and made to work for us, the more opportunities for accomplishment will be offered, and those accomplishments are the number one source of success, security and competitive advantage

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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