Advice You - Business

In their book ‘The Machine That Changed the World’, published in 1990, Womack, Roos and Jones identifi

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

ed the characteristics of automotive companies that have achieved a sustainable competitive advantage by adopting

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

Examples of combination products may in

different management ‘style’. They described these companies as ‘Lean Organisations’ beca

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

use they consistently achieve more with fewer resources, and exceed their customer’s expectations.

In 1990,

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

they forecast that Toyota, then ranked seventh in the world, would overtake GM to become the largest global, and m

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

Combination pro

ost successful, car company within 20 years - highlighting the challenge faced by their competitors in Europe and

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

merica. The secret of their success appears to be a management philosophy that recognises and values the contribut

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

ion of all employees –empowering, and expecting, them to improve the way they work through a process of cont

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

nuous improvement – identifying and eliminating waste in all areas of the business.

The effect of on every

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

key measure of business performance has been staggering. So for the last 26 years, their competitors have used TOY

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

TA as a bench mark and have attempted to replicate their results by emulating the Toyota Production System –

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

Following aspects would a

but in 2007 Toyota will replace GM as world’s largest car company – whilst Ford celebrate as 50% of th

dd to the challenges in developing combination products:

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

eir US workforce choose redundancy.

So, why do managers steeped in the corporate culture of the USA and Europe fi

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

d it hard to become Lean? In many organisations the greatest obstacle, is Dyslexic Managers – who attempt to

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

‘go Lean’ but ‘become mean’ – expecting to gain all the benefits of ‘lean thi

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

king’ without thinking or appreciating the need to change their own style and philosophy. Dyslexic managers

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

Professional from academic institutions, pharmaceutical industries, health care indust

are often recognised by their obsession with performance measurement and KPI’s when they are unable to descr

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

be the process or explain how the chosen measures of performance would identify their own incompetence.

So as you

.

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

plan your next business improvement initiative, or reflect on recent failures –ask yourself ‘Have we

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

Companies that provide selfless information through particip

ot dyslexic management?’

If change is led from the top – perhaps you need to change before we continu

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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