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Most managers simply herd some people in a room with a flip chart and call it a brainstorming session. Yet there is a definite process that maximizes the size and quality of the idea pool. While there are h

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

undreds of valid techniques for doing this, below are just some of the important concepts leaders should consider.

a) The sum of ideas produced by individuals acting alone is greater than the sum of ideas

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

Examples of combination products may in

roduced by those individuals acting as a group. Further, the diversity and novelty of ideas produced by individuals acting alone is greater than produced in a group. This means that asking group members 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.

hink of a set number of diverse and novel ideas before the session and then repeat the process during the session results in greater total output. Be sure to insist that individuals think of new ideas in th

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

group session.

b) Individuals are prone to competency traps and path dependency. This means that it is hard for them to rapidly frame break unless new experience, stimuli or knowledge is introduced. One s

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

Combination pro

lution is to import competencies. Bring in new and dissimilar individuals. Try and ensure these new individuals score high on expression, tacit knowledge and status.

c) Brainstorming usually implies that t

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 solution to a problem is being sought. Thus one good principle is to break the session into three parts – problem identification, idea generation and idea selection. It is amazing how many different perce

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

ptions of a problem often exist. Each problem definition generates its own set of ideas. This stage-process allows the separation of creative from critical thinking. Writing and editing are two very differe

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

t processes.

d) Set incremental goals. Incremental goals produce more output than “do your best.” Further, they trigger prolific production; it can be said with great certainty that quality is closely conn

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

cted with quantity – the single best creative product tends to appear at that point in the career when the creator is being most prolific.

There are at least two types of incremental goal: 1) short term –

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

his forces production of output and 2) longer term – this allows problems to incubate at various cognitive levels and results in the required insight.

e) Foster collaboration instead of competition. Compet

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

Following aspects would a

tion causes people to shut down, restricts the flow of information and creates core and peripheral groups. On the other hand, collaboration allows the intellectual cross-pollination that is the raw material

dd to the challenges in developing combination products:

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

for the idea generation process.

f) One of the top idea generation killers is slow or non-existent implementation. People just will not take idea generation seriously if nothing tangible resulted from the

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

last brainstorming session. Ensure direct links to decision makers and visible progression through the innovation process – idea selection, development and commercialisation.

g) Don’t rely on “creative typ

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

es.” Everyone can generate large numbers of diverse and novel ideas. Whilst there are assertions that there are creativity traits such as lack tolerance for conformity and tolerance for ambiguity, these the

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

ries are questioned on the basis that traits are hard to identify, isolate and are not stable or transferable across situations. Further, other criteria such as motivation and competencies are critical.

h

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

Professional from academic institutions, pharmaceutical industries, health care indust

Think beyond brainstorming. The concept of brainstorming as the only effective method of good idea generation is questionable. Some brainstorming negatives include: 1) dilution of ideas, 2) lower rates of

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

participation from individuals who score low in expression and 3) evaluation apprehension. Idea boxes, idea intranets and knowledge bases are just some methods of maximising the contribution of every indivi

.

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

ual.

These and other topics are covered in depth in the MBA dissertation on Managing Creativity & Innovation, which can be purchased at http://www

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

Companies that provide selfless information through particip

managing-creativity.com

Kal Bishop, MBA.

************************************

You are free to reproduce this article as long as the author's name, web address and link to MBA dissertation is retained

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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