Advice You - Business

There has been a tremendous growth in the number of companies adopting business improvement programs such as process reengineering, 6 Sigma, lean manufacturing, the Baldrige Criteria for Performance Excellence and, CMM/CMI as we

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

ll as other total quality management programs. This would lead one to believe that there maybe a broad understanding that there needs to be an effective way to institutionalize change management in order to cope with competitive

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

Examples of combination products may in

pressures and the demands of a dynamic marketplace.

Unfortunately the need to improve may exist but the evidence shows that the best of intentions are prone to failure. The reason for failure is a list as long as the number of

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

available programs. Not least among all the reasons for failure is:

• lack of senior management commitment,
• the effort is viewed as a program and not a viable strategy,
• the process is managed via a separate

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

organizational unit, and
• the preponderance of work is expended arguing about which tools to use.

The common denominator is that more often than not failure occurs as a result of trying to cram your situation into som

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

Combination pro

eone else’s model for success.

Just like no two snow flakes are alike, no two organizations will respond the same way to the same stimulus. Organizational differences, or cultures, indicate that there might also be differences

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

in how change should be viewed and implemented or which program will or won’t work. Fortunately all of the issues can be greatly minimized, and process quality can be enhanced, by focusing the improvement on strategy (why), str

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

ucture (how), and results (what).

Quality is not a competitive advantage but the absence of quality is a competitive disadvantage. Today quality, of both products and services, is the price of admission. We’ve been through the

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

quality revolution and if you don’t have it by now you’re probably going to get it. Quality must remain, as Ford says, job one making it vital to continue use of those strategies, processes and tools that have brought you to yo

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

ur current level of success. However, what good is the best product or service, delivered where the customer wants it, at a competitive price, in the correct quantities, at the level of quality they’ve come to expect if it isn’t

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

on time?

Of all the quality related options available to gain a competitive advantage, the one worth the company’s valuable time and attention is speed. As a business strategy that means, redirecting thought, energy, resources

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

Following aspects would a

and attention from cost to time. Time-based strategies provide a greater variety of products and services at lower costs and in less time. In addition, properly implemented, time-based strategies produce rapid and real results.

dd to the challenges in developing combination products:

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

In their book, Competing Against Time, George Stalk and Thomas Hout identified the Point Zero Five to Five Rule which states that most products and services are only receiving value .05 to 5 % of the time they are in the organi

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

zation’s value delivery systems. It doesn’t take a rocket scientist to figure out that 95 to 99.95% of the time you are doing work nothing is happening.

Tom Peters said, this rule is the world’s greatest good news/bad news stor

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

y. The good news is that in all probability many of your processes are so messed up that there is an awesome opportunity to get better. Just by starting to look at what you are doing, assuming that the .05-5 Rule is in effect, y

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

ou’ll get better. The bad news is that if your competition starts looking at what they’re doing before you start, you could get nailed to the wall. The message to senior managers is get fast or fall behind.

The “fast or fall” a

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

Professional from academic institutions, pharmaceutical industries, health care indust

pproach and supporting business structure is not new or unique, it’s tried and true; it’s called Business Process Improvement through Cycle Time Reduction. Increased speed through cycle time reduction does not detract from, or r

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

educe, a commitment to quality. It builds on all of the programs and tools that have been in use for more than ten years, Continuous Improvement, CI squared, TQM, TQL, Lean, 6 Sigma, etc. They basically represent the same proces

.

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

s, perhaps with different names and tools but the same thing none-the-less. What cycle time reduction does, in effect, is to take all the good represented by the different programs and add speed. Speed is the focus of BPI throug

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

Companies that provide selfless information through particip

h cycle time reduction.

In the future neither you, your competition, nor your customer will be the same so you really don’t have a choice if you are serious about growing your business. Get fast or fall behind – what will it be

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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Stress is our reaction to people or things going on around us. Sometimes the situations are positive and other times negative. When you are unhappy about how things are going, there are three strategies which will help you move forward in a positive direction. To mange your mood, consider your needs, wants, and values before you choose one of the three strategies. Then take positive steps to move forward confidently.

In keeping up with the fast-changing telecommunication scenario, the global Telecom Companies are vying with each other to offer the best in terms of services to the consumer. Ultimately it is the consumer who is benefiting, in terms of receiving the latest easy-to-operate telecom services and devices. New features and facilities are being added to the existing services.

The article is about management courses, in a specific way that explains the different levels of such courses, what each type of course contains, how each different type and level of course should help you, how it should change you, and also this is about how each type of course is regarded in the world of business and management.

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