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Change is a fact of life, but that doesn't always mean that we are happy with the change, or that change is necessarily right. For instance, it is often the case that Chang

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

es introduced in one part of an organisation with the intention of improving matters, create problems elsewhere. Unchecked, the likely results of this are divisiveness, int

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

Examples of combination products may in

ernal competition and distrust. Again unchecked, a blame culture takes root and empire building develops, and the combination of a blame culture and empire-building takes t

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

he entire organisation further and further away from the customer and their requirements. Some people "get lucky"; others are blamed for problems over which they have no co

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

trol. Management see tends where there are no tends, and miss trends where they exist. Management introduces numerous ‘initiatives’. Changes are made without learning from

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

Combination pro

the past. Any little improvement that results is short lived. Problems remain unsolved. The business suffers.

A truthful business analysis will reveal the following. How

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

ever a traditional management consultant would not consider himself wise to be honest. He needs to please his paymasters.

1. Lack of constancy of purpose or ever-changing

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

goals
• There is no planning for the long-term future, because the goal posts are repeatedly being moved. Toyota have a 100¬year Business Plan!

2. Emph

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

sis on short-term profits or goals
• Everything is focused on achieving the best quarterly results.
• Or staying within the budget and meeting the latest managem

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

ent of government impose targets.

3. Annual performance reviews
• These practices are arbitrary, unjust and demoralising,
• They nourish short-termism,

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

• They annihilate teamwork,
• They encourage a regime of fear.

4. Mobility of management
• Demotivated and poorly directed managers move from betw

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

Following aspects would a

een organizations and divisions to advance their careers.
• They have no sense of loyalty – and will have earned good bonuses due to fulfilled targets irrespective of

dd to the challenges in developing combination products:

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

the chaos they have caused.

5. Management by visible figures alone
• No consideration is given to, for example, the 'value' of a delighted customer or h

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

appy employee.

Traditional solutions:
• Ignore the situation hoping it will change
• Another new initiative
• More gung-ho leadership into yet deep

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

er trouble
• Another quick fix
• Moving the goal-posts yet again
• Another re-organisation
• Still more creative accounting

Excelsis suppo

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

rts managers and companies who are prepared to consider the total transformation of their organisation and the attitudes within it, that is :

• Want to find a ge

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

Professional from academic institutions, pharmaceutical industries, health care indust

uine, long-term solution.
• Are prepared to learn something totally new?
• Are prepared for the investment and the long-term rewards.

Excelsis offers a

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

series of in-house workshops focusing on creating a positive, contributive teams whereby people identify both problems and solutions and are helped to make and implement t

.

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

he changes themselves. Whilst drawing on much experience the principles of Edwards Deming – “The Toyota Way”.

Transformational leadership
• Innovation and

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

Companies that provide selfless information through particip

improvement
• Facilitating Change
• Creating efficient business processes
• Strategic Planning
• Benchmarking
• Improving customer relationships

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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Without a key control system you cannot be sure who has keys or how many keys they have to your property. Not having a patent controlled key system leads to unauthorized key duplication, which leads to unauthorized access to your property or employee theft.

Assuming that you've appropriately prepared yourself for the interview (personal assessment, company research, mock interview prep - - check out Career Advice page at www.beaconcareermgmt.com for more info), then the interview should be easy. However, despite all of the preparation, even the best falter when sitting down face to face with a hiring manager or human resources staff. It's one thing to outline who you are on a piece of paper (the resume), it's something else to actually explain who you are in person and face-to-face with another person.

Gone are the days of the bland, generic one-page resume. Employers these days are more impressed by a resume that is customized and they tend to give jobs to interviewees that have a bit of knowledg...

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