Main Subject - Business

Introducing new products or services, bringing new people on board, developing a new process or procedure, installing new equipment, change seems to be the one constant in business today and change always

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

seems to drive a need for training.

In conducting training needs analysis at any level, we need to understand that training may not be the solution, at least not the whole solution. Training is normally e

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

Examples of combination products may in

ployed with the expectation of changing individual performance. While training can, and does change the ability of individuals to perform, on-the-job performance also depends on other factors that form a

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

complex interconnected human performance system. For any system to produce a desired performance output, there are always a number of factors that must be managed.

Six-factors for human performance

The

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

ollowing is a six-factor system model for human performance. In principle if you manage all six well, you will get the desired performance. If you ignore any of the six, the desired system performance beco

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

Combination pro

es less likely. Training can indeed be an important part of a system solution, but if other parts are not provided, training may not be effective.

1. Make expectations clear:

The expected outputs, and ac

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

tions to produce results, must be made crystal clear. These include vision, values, mission, roles, goals and objectives, action plans, milestones and standards. If you don’t tell them what is expected,

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

on’t expect results.

2. Provide necessary resources and conditions:

No one can produce the expected results if they do not have the process, methods, tools, materials, space, time, money, and people to d

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

the job. A workplace that is badly designed, uncomfortable or unsafe also makes it difficult to perform. Given the means, they can deliver performance. If not...

3. Measure the performance of the system

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

:

In order to determine if expected results are being achieved we need to measure the performance outputs. It might also be helpful to monitor in-process indicators, which affect system outputs. Using m

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

trics we can identify progress toward targets, verify performance as desired, or identify problems and opportunities for improvement. We all pay attention to what gets measured.

4. Communicate progress an

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

Following aspects would a

results:

Continuous and visual feedback on the performance and results achieved by the team and system allows for quick recognition and correction of problems and implementation of improvements. If indi

dd to the challenges in developing combination products:

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

viduals do not know how well the system is working it is difficult to achieve the desired results, much less make improvements. Performance knowledge empowers improvement.

5. Provide appropriate incentive

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

:

Consequences are important. Positive rewards for good performance, congratulation, recognition and celebration, promote and encourage the behaviors that produced the results. Take care to avoid negativ

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

consequences for positive performance, or benefits for negative performance. If it felt good, they’ll want to do it again.

6. Develop necessary competency:

Competency is the ability of an individual or

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

team to successfully perform a specific task or activity. Sometimes if you are lucky, you can hire a competency off the street. More often development through training and practice is required. Competencie

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

Professional from academic institutions, pharmaceutical industries, health care indust

are built through learning activities, and through experience. A competency requires skills, knowledge, and attitude sufficient to do the job. A competency has observable measurable outputs and behaviors.

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

An individual must have the capacity, both mental and physical to learn and to perform the task or activity. If you’ve got the skills and knowledge you can do the job.

The next time you ask how to improve

.

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

performance, take a systems approach and remember to consider how to manage all six human performance factors.

We get exactly the results we manage for.

--

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

Companies that provide selfless information through particip

ee of charge, as long as the resource box is included with the article. If you do run my article, a courtesy reply to hsommerfeld@automatedlearning.com would be greatly appreciated. © 2004 Howard Sommerfel

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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Resistance is a nuisance. You want to carry on, get up to speed but all kind of people are pulling your sleeves with a lot of questions, criticism and other hindrances that slow you down.

Industrial Lubricants; it isn’t something that most of us pay any attention to, but it is undoubtedly one of the most important parts of any machine – without it, many moving parts wouldn’t function. Simply put, an industrial lubricant is considered to be any fluid, grease or oil designed to reduce friction or wear and tear between moving parts.

Any business has physical resources, such as machines, buildings, equipment and facilities to run its operations. These fundamental resources are also called enterprise assets. Organizing these assets in an orderly and systematic manner to produce an integrated unit is called enterprise asset management.

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