Advice You - Business

"Bureaucracy - any administration where action is impeded by unnecessary procedures"
- Collins Concise English Dictionary

In your own organisation, do you ever think

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

"Why are we doing this?" or "Why aren't things moving as planned or desired? Do you notice people becoming more difficult to deal with? Do you sense a rising level of f

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

Examples of combination products may in

rustration? Has your workplace lost its shine? Perhaps it's becoming or already is bureaucratic.

Often unnoticed in an organisation's growth is a tendency towards burea

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

cracy. It's rarely intentional, yet very common.

Here are some other symptoms of bureaucracy:

• Ineffective meetings - too long, too frequent, too little value.
•

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

Less direct and personal communication - too many emails or "memos".
• Ever growing procedures and operations "manuals"
• Defensive, protective and internally c

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

Combination pro

mpetitive decisions and behaviour. Shows as fear-based thinking - "we better do this in case…" or "we better not do this in case…"
• Growing sense of mediocrity in h

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

uman performance.
• Gradual loss of original purpose.

Bureaucracy is cancer of the organisation - unnecessary growth that becomes self-serving.

Because the bureaucr

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

cy grows within the culture of the organisation, it is seldom noticed by those within and rarely effectively dealt with by those within - after all, they are the unintentio

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

nal cause!

Treating bureaucracy requires awareness, courage, determination and correct action with the full commitment of leadership.

Like most cancer treatment, the comm

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

n approach is to cut burn and poison. The results too often are "It grew back again" or "We cured the bureaucracy but the organisation died".

Bureaucracy is best prevente

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

d and treated by leaders ensuring the culture has these characteristics:

• All systems are simple, connected and serve the prime purpose of the organisation.
• A hig

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

Following aspects would a

h level of functional direct personal interaction and communication throughout the organisation.
• Continuous though careful pruning of the unnecessary.
• Alw

dd to the challenges in developing combination products:

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

ys challenging procedure with the "Why" question. If the answer is defensive, protective or fear-based - seek to prune it.
• Avoidance of complacency and blind accep

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

tance of any routine. If anything requires "rationalisation" or "justification" it means something is already not working.
• Well managed yet adventurous risk takin

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

for innovation, simplicity and above all, to best serve the prime purpose of the organisation.
• Allow appropriate time and training for new processes to be properly

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

learned.
• Ensure crystal clear unambiguous communication of correct and useful processes.
• Continuous challenge of continuous growth - it's not natural! Mor

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

Professional from academic institutions, pharmaceutical industries, health care indust

often it's actually cancerous growth currently disguised as more profit, more opportunity, diversification etc.
• Stepping outside the organisation frequently to rev

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

iew it holistically.

Experience has shown that executive team meetings designed to eliminate the negative aspects of bureaucratic process are best facilitated by an indepe

.

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

dent external facilitator, capable of respectfully challenging the discussions.

Experience has also shown that most organisations have no processes designed to minimise bu

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

Companies that provide selfless information through particip

reaucracy, and in fact have processes that unintentionally create it.

Can you imagine the return on investment for designing and implementing a bureaucracy busting process

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/925/adviceyou-How-to-Bust-Bureaucracy.html">How to Bust Bureaucracy</a>

BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/925/adviceyou-How-to-Bust-Bureaucracy.html]How to Bust Bureaucracy[/url]

Are you a small to medium sized business owner? If so, you may want to consider outsourcing a number of your business services. One of the many services that you may want to consider outsourcing to another individual or company is your business mail. If you choose to do this, you will likely be seeking a business mail service.

When the first generation of women entered the workforce in earnest in the 1970s, they succeeded in the only way they could – by imitating men. Authoritarian leadership and tight control was the hallmark of that day's businessman, and women were not exactly welcomed into the ranks of management. Well ladies, that was yesterday, and today is today

While surfing the 'net, I came across a report about the reduction of identity theft and identity fraud. Obviously, it caught my attention. Following, in part, is that report which was produced by Javelin Strategy & Research, and co-sponsored by CheckFree Corporation, Visa Card, and Wells Fargo & Co.

Tags

Links

Advice You - How to Bust Bureaucracy

Related Articles: