Main Subject - Business

Have you ever tried to drive somewhere without proper directions? This almost always turns out to be a frustrating experience. Sure, if you stop and ask enough people you may eventually reach your target desti

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

nation, but think of all the wasted energy, time, and resources needed to accomplish your goal.

Let's take this concept and move it to the realm of managing a business. Does it make sense to expect your emplo

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

Examples of combination products may in

ees to reach a goal or strategic objective without providing them a road map of where they are headed? This is the reason clear and detailed employee performance objectives play a crucial role in helping compa

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

nies perform to their business plan and achieve their strategic goals.

Performance objectives establish how your business plan will be achieved. Performance objectives also play a major role in defining the e

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

d results expected through your staff's hard work and dedication. Performance objectives are a necessity in setting clear goals for employees. They also challenge staff members to achieve maximum results to pr

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

Combination pro

mote business growth and make continuous improvements to meet the challenges and changing demands of the marketplace. Performance objectives must be clear and guide action.

Now that we understand the importan

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

ce of clear performance objectives, lets investigate the criteria of a well documented performance objective.

Criteria of a Successful Performance Objective:

Specific
What specifically is

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 be achieved? Not just what actions are to be performed, but what results are to be achieved through these actions? Keeping objectives simple ensures they are clear and specific. This also reduces the chance

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

or disputes or confusion come performance appraisal time. Complex objectives should be broken into sub-objectives. This allows individuals to focus their efforts and guides them in marshaling the resources nec

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

essary to achieve results.

Measurable
How will you know how well an objective has been achieved? Although it may not be readily apparent, every object can be measured. Some objectives can be measu

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

ed quantitatively; others must be measured qualitatively. What data will be used to measure/track what is achieved and is that data available to provide ongoing feedback on how the employee is doing? Measureme

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

Following aspects would a

ts are subject to change and should be reviewed periodically.

Accountable
Accountability for performance objectives must be crystal clear and must specifically state who is accountable. The more d

dd to the challenges in developing combination products:

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

etail the better. A clear definition of what he or she is specifically accountable for will help reduce confusion come performance appraisal time. Defining accountability will ensure a sense of urgency and pur

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

ose on the part of the employee.

Realistic
For an objective to be meaningful, it must be realistic and reasonable. A well written performance objective focuses on the goals and objectives required

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

to meet the objective. In highly efficient organizations, performance objectives ultimately link back to the company's overall strategy and business plan. Objectives should challenge employees towards continuo

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

us improvement, but should not be unrealistic or unattainable.

Time based
An achievable time frame must be set for reaching the objective's goals. Consider assigning specific target dates not only

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

Professional from academic institutions, pharmaceutical industries, health care indust

for the performance objective itself, but also each lesser milestone linking the entire goal. Remember to be specific towards achieving results and guide action in a results oriented ways towards the objective

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

Strategically Linked
Every performance objective must always be linked to the overall business plan and over-arching strategy of the organization. Well thought out performance objectives create a

.

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

link between the direction of each individual employee which also align upstream through departments and divisions to unify the goals of the entire organization.

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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

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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 - The Key to Successful Performance Objectives

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