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Creativity and innovation are magic wands. They endow projects with enhanced performance. After all, two fundamental PMI qualities of all projects, progressive elaboratio

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

n (iterating from concept to final deliverables) and the fact that all projects produce unique results, demand that project managers foster as much creativity as possible

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

Examples of combination products may in

.

Apply techniques that combine left and right brain logic and creativity.

Reframing: This technique requires you to ask questions about your project which will lead to

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

new frames of references to old problems. Questions asked may include: (a) What are the obvious realities of a situation and how can they be changed? (b) What are typica

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

complaints? (c) What ideal situation do we seek?

Force Field Analysis: This method consists of identifying forces which contribute to or hinder the solution of a proble

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

Combination pro

m. Creative thinking is encouraged by clearly defining goals as well as identifying strengths to maximize and weaknesses to minimize.

Attribute Listing: This approach fo

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

cuses on identifying attributes of a process or product and how to improve one or many of them. It is similar to force field analysis but the attribute listing provides n

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

utral aspects as opposed to negative or positive aspects of a problem.

Scamper: This acronym stands for Substitute, Combine, Adapt, Modify, Put to other uses, Eliminate

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

and Reverse or Rearrange. Address each of these issues and determine what new ideas emerge.

Alternative Scenarios: Explore plausible futures for your project or product

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

and you will gain a deeper understanding of potential environments in which you may have to operate. Build scenarios on the basis of principal forces and influences. Busi

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

ess opportunities within these scenarios formulate a future strategy.

Forced or Direct Association: Combine two concepts which have little in common, then brainstorm to

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

Following aspects would a

draw possible relations between the two. Fresh approaches to old problems may result.

Design Tree: This type of "mind map" is helpful when a central topic such as a prod

dd to the challenges in developing combination products:

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

uct, market or process must be built on. By literally mapping out related ideas on a large sheet of paper, obvious results may be transformed into potential breakthroughs

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

. Tuning into our intuitive good sense allows you to take that leap into generating new ideas. Consider the following: Imagery: Create multi-sensory images in your mind

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

to address the issue at hand. The intuitive messages that are "sent" to you can then be applied to the problem at hand. Imagery requires a relaxed state of mind, a willin

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

gness to be non-judgmental and a vivid imagination.

Brainstorming: This common idea-generation approach should suspend evaluative judgements for the short-term. This tec

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

Professional from academic institutions, pharmaceutical industries, health care indust

hnique is effective in both a group and a private setting. The problem at hand should be stated in neutral terms.

Analogy: The similarity between two conditions otherwis

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

dissimilar is explored. Personal analogy identifies you with an object or process. Direct analogy compares parallel facts in two different areas in order to generate fre

.

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

sh solutions. Symbolic analogy uses an image that may be technically incorrect, but which describes the implications of a key aspect of the problem.

Meditation: This sta

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

Companies that provide selfless information through particip

te of heightened awareness may release an inner source of creativity.

In the words of Alan Kay of Apple Corporation, "The best way to predict the future is to invent it.

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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