Advice You - Business

Managing for Best Performance

In it’s simplest form, performance management is a common sense set of discussions that make sure people are clear about what they need to do, have the support to do it and get

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

open and honest feedback on their performance.

Any performance management process should answer 4 important questions for your employees:

· Direction: What do I need to do and how well?
· Feedback: How am I d

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

Examples of combination products may in

oing?
· Rewards: What happens when I do well?
· Support/Development: What happens when I need/want help?

Lets look more closely at each of these:

Direction

Employees are not mind readers. Just

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

ecause it is clear to the manager exactly what is expected, doesn’t mean the employee has the same understanding. Having a detailed discussion about exactly what the job requires and any specific priorities is the f

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

irst step in good performance management. Key points to cover include:

- what needs to be achieved throughout the year

- what data or information (evidence) will be used to measure performance

- the key actions n

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

Combination pro

eeded to achieve the desired outcomes

Both parties should have a written record of this discussion either in the form of a job description or a set of specific objectives for the next 6 or 12 months. Written docume

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

tation leaves little room for misunderstandings or confusion between manager and employee about the expectations of the job.

Feedback

Observing the performance of your employees and providing feedback about

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

it should be a routine part of the performance management process. Feedback is most effective in making a difference in work performance when the employee has confidence in the basis of that feedback. And you as th

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

e manager will be more confident if your feedback is based on information that you can support.

For this reason the most useful feedback should be based on observed and/or verifiable work-related behaviors, actions

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

statements, and results. If you can provide specific examples of good and “not so good” performance, your employees will be confident that you have taken time to notice what they are doing and sincerely support the

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

m in improving. This kind of effective feedback helps the employee sustain good performance, to develop new skills and to improve performance when necessary. Feedback should be given as it is required – it loses eff

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

Following aspects would a

ectiveness if not delivered at the time an event occurs.

Reward/Recognition

All employees need to have a clear understanding of how the reward and recognition system operates in your business. Most probably

dd to the challenges in developing combination products:

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

everyone gets paid a salary for doing their job to a certain level. What happens when an employee performs significantly above that level? How will they be rewarded, if at all? If there is no incentive for employees

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

to be outstanding, then the likelihood is that they won’t put in the extra effort. A well designed scheme will clearly identify the rewards and incentives available for strong or outstanding performance.

Suppor

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

t and Development

This aspect of managing performance focuses on current and future skills, behaviours and knowledge. Firstly, the discussion should focus on what training or other support the employee needs to

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

be the best in their current job - identifying skills and behaviours that need to be improved. If you can support the employee in doing their job better, they will have reassurance that their contribution is valued

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

Professional from academic institutions, pharmaceutical industries, health care indust

by the business. The discussion should also focus on where the employee would like to go in the future and how you can help them achieve their longer term career goals. If they are being considered for other roles i

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

n the business then you will need to identify what new skills and behaviours they need and help them to develop those.

If you are managing people, then people management activities need to take up the majority of y

.

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

ur time. Each business can only be as effective as the people that work in it. One of the best ways to ensure your employees are being effective is to monitor and provide feedback on their performance. Setting goal

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

Companies that provide selfless information through particip

s, making sure your expectations are clear, and having regular discussions will help people perform to their best. The payoff for the business is increased employee productivity, knowledge, loyalty and contribution

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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