Digg It - Business

Anyone living on this planet knows that the Japanese system -- if not broken -- is in serious need of repair. The nenkojoretsu system (the literal translation is “years-merit-order”) channels millions of workers in an orderly, p

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

redictable way through the corporate system.

Examples of the nenkojoretsu system:

• Longevity determines a worker’s rank in the organization.

• Competence is equated with age.

• Experience counts more than expertise.

• Each

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

Examples of combination products may in

pring, and with no explanation, workers receive slips of paper advising them of nearly identical raises.

• During the first 15 years with their respective company, workers receive promotions regardless of their ability.

• The b

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

est indication of high performance: Working long hours.

• Workers are never told where they stand; their performance is not measured. Workers must sense how they are doing by how they are treated in after-work drinking session

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

with coworkers.

Result: Japanese payrolls are bloated with 2 million to five million under-utilized workers. Companies’ operating expenses are so high that they can no longer compete in a fast-changing world market that deman

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

Combination pro

ds flexibility.

Of course, this is the same system that allowed Japan to rise from worst to first with respect to quality. But the system has run its course. The time has come for change. We can change too.

North American co

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

panies may not have the specific name for our “system,” but many of the characteristics are practically identical to those found in Japan. It’s not at all unusual to visit large and seemingly progressive North American companies

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

and find compensation systems in place that are heavily based on management discretion:

• No merit-based pay.

• No job descriptions.

• No measurements.

• No formal performance reviews.

• No minimum conditions of employment.

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

• No guidelines for overtime pay.

(In Japan, white-collar workers have been averaging 60 hours a month in overtime. Management ignored how much overtime was wasted, resulting in little additional productivity.)

Management has

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

always been a tough job, but the most profitable firms I observe are managed by proactive men and women who are goal-oriented; they set strict standards and reward the employees who meet and exceed those standards. The most eff

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

ctive managers have the reputation for being tough, but fair. Employees who are just “holding on” are not tolerated.

Many of managers who are critical of our government entitlement programs are equally guilty of tolerating them

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

Following aspects would a

within their own companies. Ask yourself these questions:

• How many of my employees who received raises this year actually deserved them?

• How many of the employees who are currently on my payroll have I given up on and shou

dd to the challenges in developing combination products:

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

ld replace?

• How many of my current managers earned their promotion as a result of longevity rather than merit?

• How many of my current managers have plateaued?

Bloated payrolls will eventually lead to financial disaster in

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

ny industry. Performance standards of just five years ago are no longer adequate for most businesses to effectively compete, especially in large metro areas.

Remember the four-minute mile? For years, it was a barrier no one co

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

uld imagine breaking. Then on May 6, 1954, a British runner, Roger Bannister, finally did it. He ran a mile in 3: 59.4 minutes. As soon as one man broke the four-minute barrier, just a few weeks later, Landy, a runner from Aus

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

ralia, broke Bannister’s record. Since that time, over 1,000 runners have run a mile in under four minutes. In 1958, in Baton Rouge, five runners did it in the same race.

How does the productivity of your people this year comp

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

Professional from academic institutions, pharmaceutical industries, health care indust

are to their productivity five years ago?

What gross profit per payroll dollar are your people achieving this year versus five years ago?

The pressure is on. New productivity records are being set every day. The competition i

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

heating up. These new productivity increases are putting increased pressure on gross margins. Companies that expect to earn satisfactory bottom lines have no choice but to attack operating expenses. And since in most organiza

.

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

tions approximately 60% of total operating expenses reside in personnel-related expenses (salaries, group medical, workers’ comp, payroll taxes), payroll is the first place to concentrate.

Change is no longer a choice

If you’re

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

Companies that provide selfless information through particip

not setting performance-based conditions of employment in your organization, you will soon find yourself unable to compete. The gross profit you are able to generate will simply be inadequate to cover your cost of doing business

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.diggit.org.ua/article/23094/diggit-Is-Your-Management-System-in-Need-of-an-Overhaul.html">Is Your Management System in Need of an Overhaul</a>

BB link (for phorums):
[url=http://www.diggit.org.ua/article/23094/diggit-Is-Your-Management-System-in-Need-of-an-Overhaul.html]Is Your Management System in Need of an Overhaul[/url]

Organisational success depends on arriving successfully at the meeting point between process excellence, effective risk management, the allocation of resources and having effective partnerships - and this thought leading article introduces the reader to this new way of thinking.

Have you noticed that some people can put across the most unpopular idea without trouble, while others manage to cause offence with the blandest statement? This article suggests ways to become more skillful in customer communications.

Buying and selling cars for profit is one of the few businesses that makes money in a good or bad economy and here are five reasons why this unusual business is a true recession proof business.

Tags

Links

Digg It - Is Your Management System in Need of an Overhaul

Related Articles: