Advice You - Business

There are two questions that seem to be most commonly asked by organisations who are looking to change the direction of their business; namely:

1. Where do I

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

start?

and

2. Why is it so hard?

Research quoted by Henley Management College stated that the UK wastes around ?25Bn per year on improvement programmes wh

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

Examples of combination products may in

ich go wrong and our own research, collated from a number of sources, suggests that upwards of 80% of all improvement activities will fail.

With ‘Lean’ becom

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

ing the improvement tool of choice within a wide range of sectors, including Financial Services, Armed Forces, NHS, Public Services and the Service Sector, it

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

is already becoming apparent that these sectors are suffering from the same problems with implementation that were first seen in ‘Lean’s’ home, manufacturing

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

Combination pro

.

Whilst organisations have focused on the tools of Lean, everything from adapting 5S and SMED for office and service environments, there has been little tho

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

ught applied to the methodology of implementation – namely, ‘Where do I start?’

Further analysis shows that many of the reasons why Lean Improvement Programm

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

es fail can be traced back to decisions and actions either taken or omitted prior to the start of the change process – broadly these decisions can be classed

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

as:

* Issues surrounding the planning and application of the tools
* Issues around the engagement of people and the communication of change
* Issue

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

s around the development of managers to drive the change
* Issues around the leadership and management systems and behaviours to support the change

Ther

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

fore, perhaps the secret solution to making Lean improvements work lies in having a defined methodology to enable people to be able to understand the Lean Jou

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

Following aspects would a

rney (answering the ‘Where do I start?’ question) and a plan of attack to create the right organisational environment to enable the improvements to take hold

dd to the challenges in developing combination products:

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

(answering the ‘Why is it so hard?’ question)?

Well, the answer to the questions above is ‘possibly’ because it all relies on having the expertise to answer

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

the questions that arise – such as ‘What is the right methodology for my business?’, ‘What is the best management structure for my business to support the imp

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

rovement?’ and ‘How do I overcome organisational inertia?’

Sadly, most people who look to implement Lean (or Six Sigma for that matter) come from an engineer

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

ing or ‘tools’ background, meaning they fully understand the logic of the improvement tools but often do not have the expertise to address the cultural change

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

Professional from academic institutions, pharmaceutical industries, health care indust

and organisational development aspect or impact of what they are proposing. Alternatively, the facilitators come from HR/People/Change Management backgrounds

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

and provide expert facilitation for the teams but little in the way of actual direction. Either approach is normally doomed to failure, either dramatic or gr

.

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

adual.

Therefore, the real secret to success is to combine a strong methodology with supporting activities designed to align the organisation behind the chan

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

Companies that provide selfless information through particip

ge and back it up with an approach based on a strong understanding of the tools of improvement and the ability to inspire and coordinate individuals and teams

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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