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There are wild variances in how much involvement organisations are brave enough to offer their people in change. F

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

rom those organisations where they just ‘tell’ (sometimes by text message even!), to the most enlightened extreme, where t

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

Examples of combination products may in

ey enable wholesale contribution to the change process.

Such organisations actually create the time and space to i

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

volve as many people as possible, in the issues surrounding the need for change.

This organism of change, where the organ

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

sation fully respects (an important word in this context), the ability of individuals to contribute, not in a patro

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

Combination pro

ising way, but more in a synergistic and fully contributory way, enables two significant and positive steps.

Firstly, inv

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

lvement in the creation of change solutions, empowers people in what can be a very disempowering situation. They b

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

gin to have a role in their own and their organisation’s future.

This leads to a second significant point. The ow

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

ership of the solution shifts, so that individuals get really bought into the need for change and that they can contribute

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

sometimes much more than can be expected. Their empowerment values them as never before.

This can, with acute aw

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

reness on the part of senior managements, move the organisation from fire-fighting when things go wrong, to an ongoing sea

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

Following aspects would a

ch for quality, review and questioning of assumptions. This becomes as Ricardo Semler found in his wonderful book,

dd to the challenges in developing combination products:

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

‘Maverick’, rewarding holistically, for the organisation, the employees and also the locality as a whole.

A marvel

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

ous example of embracing change, freeing a business owner and exemplar leader, and his team to realise their true p

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

tential.

An exercise to consider...

Think about changes where you have been involved.
How were the changes

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

aunched to you?

What were your feelings at the time?

What are your feelings now, in retrospect?

<

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

Professional from academic institutions, pharmaceutical industries, health care indust

i>What might have made the experience better, in light of the information above?

How might you have ‘done it differen

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

ly’?

In your own organisations, what opportunities do you have for involving your people in change?

How c

.

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

uld you explore this further?

What could you do in the next month?

What will you do?

Change

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

Companies that provide selfless information through particip

s an opportunity which can grab you any way you choose - or you can take the lead and choose your own path..

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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