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Creativity can be defined as problem identification and idea generation and innovation can be defined as idea selection, development and commercialisation. From this simple definition, it is clear that certain cult

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

ural characteristics ought to be prevalent if creativity and innovation are to be maximised. And maximisation of these ought to be a priority for senior leaders, as those organisations that take them seriously, ten

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

Examples of combination products may in

to be leaders in their field, tend to maintain their leadership position longer and are quicker to bounce back when competitors leap frog.

There are many blocks that prevent expression of problems and hinder idea

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

generation. Some solutions include:

a) An environment of psychological safety and freedom – accepting an individual as unconditioned worth; recognising that the individual is capable of producing but that their va

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

ue is not based on producing; understanding empathetically; understanding the individual from their point of feeling and view (Vernon, 1970).

b) Tolerance of failure – Accepting that many ideas will fail before on

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

Combination pro

worthwhile one will surface and reach commercialisation; recognising that there are benefits to failure, such as competency expansion – Blade Runner was initially a commercial failure yet Ridley Scott went on to m

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

ke some very successful movies. The Economist (2003) states that 3000 bright ideas result in 100 worthwhile projects, which are winnowed down to four development programmes. And four such development programmes are

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

required to stand any chance of getting one winner.

Though senior leaders pay lip service to the above, the reality is often much different. Below are some easy and simple tests to gauge how well your organisation

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

is performing in practice.

a) Employee interviews. Are interviewees expected to conform to the prevalent norm of not contradicting the interviewer? If they do so, are they less likely to be selected? Interviewees

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

ho throw up many ideas and challenge existing methodologies at this stage are more likely to be expressive when they find problems in an organisation and more likely to bring them to the attention of decision maker

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

. They are also more likely to persuade others to do the same. Thought leaders are good drivers of change and prevent complacency – though as a result it is not unusual to find that they cause friction with senior

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

Following aspects would a

eaders who for some reason or other may be resistant to change. Remember, today’s thought leaders can easily become tomorrow’s established bureaucracy.

b) Personality conflicts are quite normal within organisation

dd to the challenges in developing combination products:

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

. Some theories argue that all interactions on some level are conflict based. But are junior people penalised when they conflict with senior people? Even if the senior person is in the wrong, do they get their way

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

or the sake of preserving the existing order, structure and processes? Is the junior person made to feel that his or her behaviour needs to be monitored under threat of some sort of negative result or punishment? T

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

is is i) contradictory to an environment of psychological safety and freedom and results in suppression, not expression, of problem identification and idea generation and ii) a strong indicator that the culture is

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

oving in the wrong direction.

c) Are senior leaders confident enough to leave themselves open to evaluation from all others in an organisation? Status deference has many negatives including i) higher status indivi

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

Professional from academic institutions, pharmaceutical industries, health care indust

uals tend to dominate the session and reduce the participation of others, ii) people allow higher status individuals to do all the idea generation, iii) people place higher value on ideas produced by higher status

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

ndividuals and iv) people have a greater tendency to allow higher status individuals to get away with bad ideas.

This topic is covered in depth in the MBA dissertation on Managing Creativity & Innovation, which ca

.

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

be purchased (along with a Creativity and Innovation DIY Audit, Good Idea Generator Software and Power Point Presentation) from http://www.managing-creativity.com. You can also receive a regular, free newsletter b

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

Companies that provide selfless information through particip

entering your email address at this site.

Kal Bishop, MBA

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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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