References - Business

Kaizen is a proven performance improvement tool. Adopted from modern Japanese manufacturers, like Toyota, Kaizen generates breakthrough improvements quickly, without huge capital investments and/or extensive commitments of employ time. Kaizen is an efficient, eff

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

ective technique for producing change in manufacturing operations.

Kaizen improves performance in non-manufacturing situations as well. Ideal for a wide variety of industries, it’s well suited for non-manufacturing situations like those found in professional ser

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

Examples of combination products may in

vices, corporate headquarters, and branch offices. Entities like finance departments, corporate headquarters, national banks, and hospital emergency rooms all benefit from it.

Kaizen is appropriate for relatively straightforward, simple problems, problems that d

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

on’t involve numerous functions or complex processes. It is also appropriate for well-defined problems or when the dissatisfactory performance of the current state is due to only a few factors that don’t vary widely over time. The format for Kaizen can be individ

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

ual, suggestion system, small group, or large group.

Reasons why a non-manufacturer would implement Kaizen include the following:

Lowers costs

Services differ from manufacturing. More variety exists in services than production. With manufacturing, the ideal is

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

Combination pro

to produce the same product at the rate of customer demand. Manufacturers abhor variety because it slows production and creates the potential for incurring costs.

With services the ideal is to accommodate variety. A call center, for example, must handle as many

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

different types of customer events as possible. Many events are the result of something not done or something not done right. Thus, services generate costs by “failure demand.”

Kaizen focuses on eliminating failure demand. Employees make suggestions on how to d

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

o things right and use Kaizen to make changes. By helping workers get it right, Kaizen minimizes the need for, as well as the cost of, doing something or providing a service. Obviously, the more things a service or non-manufacturer does right, the less cost it ge

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

nerates.

Immediate Results

Kaizen takes place one small step at a time. It’s driven to resolve specific problems. Instead of tackling large improvements, Kaizen makes minor enhances that solve large numbers of small problems. Thus, firms see Kaizen results quic

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

kly, encouraging them to make more suggestions. Large capital projects and major changes are still needed, but the real power of Kaizen is in making small improvements continually that improve processes or reduce waste. In short, Kaizen concentrates on making fas

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

t changes cost-effectively.

Reduces waste

Kaizen methodology involves making alterations, looking at the results, and then making additional alterations to improve the processes. These changes reduce waste, that is, eliminate activities adding cost only. Waste

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

Following aspects would a

includes activities like overproduction; people, materials, or information waiting; unnecessary motions by workers; and unsynchronized transportation. It also includes excess inventory, correcting defective work, and unnecessary processing steps.

Energizes Emplo

dd to the challenges in developing combination products:

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

yees

Kaizen depends on employees suggesting changes. For example, in 1999 alone, 7000 employees at a Toyota plant in the U.S submitted over 75,000 improvement suggestions, of which 99 percent were implemented. Kaizen encourages employees to come up with more and

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

more of these small improvements, motivates them to improve their work lives, excites them about their work, and challenges them to be responsible for change. In other words, it empowers employees, enriches the work experience, and motivates workers.

Increase P

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

roductivity

A major national bank used Kaizen whenever it wanted to attack process speed and efficiency problems. The projects were all well defined, involved participants pulled off their jobs for only a few days, and included a cross-functional team. The proje

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

cts also supported a cross-functional view of the process or work area.

Using Kaizen, the bank achieved cycle time improvements ranging from 30 percent faster to nearly 95 percent faster, measured sometimes in minutes and other times in days. One administration

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

Professional from academic institutions, pharmaceutical industries, health care indust

process went from 20 minutes to 12, and a complaint resolution process dropped from 30 days to 8. An added bonus for the bank was an increase in revenues. One high level project enabled the bank to charge for a service it had never charged for before. New revenue

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

s ran between $ 6 million and $9 million.

Kaizen produced similar results in an emergency room application. Standardizing layouts and stocking exam rooms increased nurse availability by 35 hours per week. Establishing a transportation procedure increased availab

.

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

ility of patient care associates and nurses by 84 hours per week. Leveraging the existing ED information system reduced cycle time 71 per cent, to an average of 42 minutes.

Kaizen is a powerful improvement tool. It isolates employees from day-to-day tasks for a

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

Companies that provide selfless information through particip

few days so they can concentrate on specific activities, like problem solving and improvement exclusively. Companies using kaizen find that they not only reduce waste and see immediate results, they also increase productivity, lower costs, and energize employees.

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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