Main Subject - Business

One of the major issues that arises in managing a small or medium size business is in the area of employee performance. Many business owners are frustrated with the poor performance of their team or some individuals within their team. No matter how hard they try, they don’t se

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

em to be able to create a sustainable improvement in performance. The tendency is to blame the employees for poor performance. However, more often than not, the problem stems from not establishing an effective performance management framework.

There are a number of elements

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

Examples of combination products may in

hat create a framework for producing premium performance.

The most important element is to establish a clear description of the required outcome of the job. This may be in terms of a position description if the job is broad and covers a number of responsibilities. Or i

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

may simply be providing a sample or a picture of an article that should be produced by the work. When there is a clear understanding of the output required, it is much more likely that result will be produced.

The second element requires establishing a best practice approach

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

o doing the work. Often there are many ways a job can be done, but usually only one way is the most efficient. A best practice approach involves determining the best way to do the job and then requiring everyone to do the job the same way to maximise efficiency.

The third element is

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

Combination pro

to establish a timeframe or deadline for the completion of the work. The employee will know if they are on track if they know how long the job should take.

When you use a best practice approach and establish a timeframe for the work, you can also provide a target for output

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

/b> over time. In other words, if you work so many hours you should produce x amount of product. This allows us to establish a productivity target.

When an employee starts a new job, it is best to teach or train the person in how to do the work. This may involve showi

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

g the new employee what is done for the first time or two and then watching while the employee tries it a time or two, or until you are satisfied they can do it without help. This is one of the most frustrating parts of the delegation process. The time it takes to complete this eleme

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

t puts a lot of people off. They need to realise that some short term pain leads to much long term gain, rather than allow the loss of some short term productivity to keep them from ever delegating their difficult tasks.

A very important element that many forget in the delegation pro

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

ess is to establish a process to measure and monitor results. One of the greatest dangers in business growth is that of losing control because growth means we can no longer physically see everything that goes on. Losing control leads to poor productivity and quality and escala

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

ing costs, all of which will destroy your business if left unchecked. Control comes from knowing the results of particular actions and being able to provide feedback or make changes if the results are outside the parameters required.

The results achieved in a job over an extended per

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

Following aspects would a

iod of time can be influenced positively by developing an appraisal process. The appraisal process should provide feedback to the employee about how they are performing in the job relative to expectations, how their performance affects the success of the organisation and how th

dd to the challenges in developing combination products:

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

y interact with the components of the organisation around them. The appraisal approach that gets best results is to adopt a coaching role with your employees, rather than an examiner role. Too often, performance appraisal meetings are set up for failure because the two parties

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

come to the meeting with different objectives. The manager wants to highlight areas of poor performance and take steps to improve these areas, but the employee wants to be told how well they have done. This often occurs when appraisals are held annually or six monthly and conflict is

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

created when the judgments are subjective. The result usually is disappointment and demotivation on the part of the employee and frustration from the manager. Both people hate the process and no effective outcome is achieved. It is much better to conduct appraisal meetings frequentl

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

, to compare actual results with targets, using objective rather than subjective measures. The coaching meetings then can be used as a discussion focused on performance improvement, instead of a confrontation about how the employee felt they had performed.

The final element of the pe

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

Professional from academic institutions, pharmaceutical industries, health care indust

formance management framework is the reward process. Every positive outcome should result in a reward for the employee. This can be tangible or intangible and dependent on the level of maturity and experience of the employee. For some positions, it is appropriate for rewards

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

o be small, frequent and immediate, where for other positions, more long term and cumulative rewards are appropriate. However, this element is often a neglected or an ill thought out part of the process and as such, has the potential to undermine results. A good reward process suppor

.

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 and enhances the management process and increases motivation for achieving premium performance.

The important lesson to learn is that results can be influenced through establishing an effective performance management framework which requires all elements to work together effectively

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

Companies that provide selfless information through particip

Poor performance often results if any elements are either missing from the process or are poorly designed and become a negative influence on performance. But a well designed and coordinated framework means that all elements work together systematically to produce premium performance

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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Main Subject - Producing Premium Performance

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