Main Subject - Business

Change is the only constant thing in the world and businesses are no exception to this universal principle. The aim of change is bringing about continuous improveme

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

nt in the competitive world through which businesses hope to surpass their competitors to meet customer needs better than the rest.

Change Meets Resistance

You ne

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

Examples of combination products may in

d to anticipate resistance from unexpected corners while contemplating and proposing change. This could be for the first Six Sigma project or for the subsequent pro

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

ect, despite rigorous results with previous project implementations. Workers may respond by ignoring the change, by refusing or failing to comprehend changes, disag

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

reeing with apparent benefits and resorting to delay tactics and tantrums. Other instances can be ignorance from other sections within the organizations and non-coo

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

Combination pro

eration on projects

Managing The Change In Six Sigma

Project leaders understand that most resistance has no valid reasons.

1. For example, let us take the case o

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

ignoring the change. People are opposed to change just because they don't want a change. Change entails doing things in a different way, which demands adoptability

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

regardless of its simplicity. They assume ignoring the change proposal will ultimately lead to its withdrawal. Make it an irreversible change, perhaps by associati

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

g annual review to the success of the changed process.

2. Failure to comprehend is another place to manage the change assertively, although this is not intentional

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

Handling things can be easier in this case. Use additional sessions to explain, such as a lunch meeting, one-on-one meetings; mailers, tables, and calendars which

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

re visible daily and can be used for tools.

3. Not accepting or ridiculing the true values of the benefits is another way of resisting change, which the Master Bla

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

Following aspects would a

ck Belt must anticipate. Use independent sources or/and positive results from other departments or projects to prove your point. See that the points are valid and t

dd to the challenges in developing combination products:

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

e team can relate to them.

4. Failure to achieve speed: Slow progress in change initiatives may bog you down, forcing you to go through multiple steps, which you m

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

y want to skip, even though they are essential. But practically, this could be futile. Break the illusion of speed and build up the momentum as you progress on a sc

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

ientific path only. This is more permanent and speedier than a diluted and scattered set of activities.

5. Sustaining and sharing the vision: They key to longevity

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

of support down the line is the shared vision, the dream and positive attitudes. Following up launches with a flurry of short-lived activities achieves nothing. But

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

Professional from academic institutions, pharmaceutical industries, health care indust

the workforce needs to be galvanized regularly to keep the vision alive. Communicating and getting together regularly will help in this regard.

6. Proof of the pud

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

ding is in eating it: Shareholders look for economic benefits out of every project, although not opposed to changes as long as they see appreciation to top line and

.

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

bottom line figures in the financial statement. You can only prove to them when you show increased profits riding on more volume and enhanced quality.

Managing the

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

Companies that provide selfless information through particip

change in Six Sigma is no different from doing it elsewhere. But the scale of the operation and the interests concerned along with wisdom should guide the way ahead

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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