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While many business professionals understand the Plan-Do-Check-Act (PDCA) cycle as it pertains to process impro

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

vement, the model doesn’t work particularly well for dealing with changes in individual or organizational behav

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

Examples of combination products may in

ors. However, an alternative model based on Gestalt psychology can be very useful, and consists of four major

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

phases.

1. Awareness – Significant change is unlikely to occur if the entity is not aware of the need for 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, which is why feedback mechanisms are necessary. Individual performance appraisals, customer satisfaction su

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

Combination pro

rveys, and reviews of organizational & process performance metrics are intended to provide opportunities to rai

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 awareness. Unfortunately it’s often only when the individual or organization “hits the wall” that they reall

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

y become aware of the need for change.

2. Willingness – While awareness provides the opportunity, without will

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

ngness to change the entity will become stuck. Blaming others for the problem, hoping it will go away, or abje

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

ct denial are ways of avoiding taking responsibility. After all, change means reallocating mental, physical an

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

/or financial resources from whatever has gotten the entity to where it currently is.

3. Movement – This is th

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

Following aspects would a

e phase where change actually occurs … where old behaviors are reduced and new ones adopted. Ensuring there ar

dd to the challenges in developing combination products:

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

support mechanisms that help protect the entity during this phase can alleviate some of the fears, as the new

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

behaviors must occur for a sufficient length of time in order to be integrated as norms.

4. Evaluation – It is

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

important to measure, either quantitatively or qualitatively, the degree to which the change was successful. I

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

nadequate progress becomes a source for increased awareness, while if the effort was successful, confidence wil

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

Professional from academic institutions, pharmaceutical industries, health care indust

improve and the likelihood of future positive change is increased. Celebrating success, cognitively and/or ma

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

terially, is important for reinforcing the successful movement through all phases of the cycle.

It’s important

.

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

to understand that change is neither good nor bad. It only seems to be as we perceive it to be, and providing

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

Companies that provide selfless information through particip

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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Every consultant has had the feeling: the conviction that your own private service practice is your true calling. Your passion quest. Yet, the mundane details of actually running a business make even the most inspired business person ask whether the choice was the right one-

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