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If you employ people in your business, you're going to be faced with a number of tricky management issues - dealing with tardiness, sick l

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

eave, and keeping your staff motivated.

Performance reviews can be useful for motivating employees, but only if they are accurate. An ina

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

Examples of combination products may in

ccurate review, which fails to recognize the employee's value to the organization, can be worse than no review at all.

If a performance r

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

eview fails to take note of an employee's shortcomings, it won't be taken seriously.

If an employee consistently performs poorly, it's vi

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

tal to document this, as well as any corrective action that is taken.

Your staff may be genuinely unaware that their performance in some

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

Combination pro

areas is poor (or exceptional!), unless you tell them.

Most employers conduct performance reviews annually, in order to decide on salary

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

increases and bonuses. Since performance reviews should build on previous reviews, it's better to conduct them more regularly - every 4 mo

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

nths is a good frequency.

Employees thrive on feedback, and regular performance reviews provide a consistent framework for providing posi

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

tive reinforcement.

Under-performing employees can also benefit. Regular reviews can identify weak performance areas, and allow you to se

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

t clear goals and expectations, and to coach and mentor the employee to improve their performance.

Objectivity is vital. You need to conc

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

entrate on measuring performance, and not on quirks of personality.

The performance review should relate directly to the employee's job p

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

Following aspects would a

rofile - your employees do have job profiles, or job descriptions, don't they? The job profile should identify the Key Performance Areas f

dd to the challenges in developing combination products:

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

or the job. For instance, some Key Performance Areas for a receptionist might be:

* answer incoming calls within 3 rings
* take mess

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

ages accurately and pass them on quickly
* type at a rate of 25 words a minute

The more measurable a Key Performance Area, the bette

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

r.

Some other measurable Key Performance Areas include:

* number of sick days
* number of absent days
* number of instances of

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

tardiness
* number of customer complaints
* number of customer compliments
* number of co-worker complaints

Of course, yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u would have to keep accurate records of all of these, in the employee's personal file.

You should prepare a performance review form for

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

each employee, which lists the Key Performance Areas for the job, and provides a matrix for you to record the performance in each area.

F

.

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

or example, you might rate the employee's performance in each Key Performance Area against a scale of 'Poor, Satisfactory, Good, Very Goo

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

Companies that provide selfless information through particip

d, Excellent'

Performance reviews should be a collaborative process - as far as possible, the employee should agree with your assessment.

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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