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Using the skills, strategies, and smarts of lawyers, you’ll be able to more effectively coach your employees to optimal performance. Here are 4 great tips to help you give constructive f

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

eedback in such a way that you motivate positive and productive performance...

1. Give evidence of performance to employee. In litigation, prosecutors are required to turn a

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

Examples of combination products may in

ll of their evidence over to the defense. In order to be fair to employees, supervisors need to do the same thing. Tony frequently received disturbing memos from his district man

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

ager about his poor performance on sales calls. "You failed to cover the Five Points for Sales Excellence with a customer last month. This is unacceptable." Tony never received a m

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

nitoring sheet spelling out the discrepancies, never heard a tape of a recorded call, and he didn't even have the opportunity to defend himself because the cowardly manager simply

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

Combination pro

shot her message off in a cold blunt memo.

Giving feedback the way Tony's district manager does is dangerous. It certainly isn't motivating Tony to improve.

Moreover, because the

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

manager has provided no proof of the calls - no score sheet, no recording of the call, no date or time, and not even one specific statement about Tony's alleged ineffectiveness -

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

Tony can't even defend his performance.

When monitoring and coaching employees, ALWAYS turn over the evidence of the call to them. This evidence may include a recorded cal

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

, Mystery Shopper score sheet, detailed notes from customer's account, etc.

2. Prepare for employee performance meetings in advance. No attorney would conduct a direct

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

examination or cross examination without thoroughly and carefully pre planning their questions. I always prepare a loose script prior to meeting with employees about problem perfor

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

mance, even though I don't actually read from my script. Writing the discussion out reinforces it in my mind and allows me to be less concerned with covering all the basis and more

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

Following aspects would a

concerned with my employee.

3. Ask open-ended questions. Asking a juror if they are for the death penalty yields a yes or no answer, but asking her how she feels about

dd to the challenges in developing combination products:

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

he death penalty gives the attorney the opportunity to learn more. Just the same, asking your employee if she thought the phone call in question was good will yield a yes or no a

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

nswer, but asking her how she thought the call went gives her the opportunity to expound. My favorite open-ended coaching questions include: "If you could do this call over again,

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

would you?" "Tell me about that caller." "Is there anything else about this call/customer that I haven't asked, but need to know?"

4. Don't allow the "Twinkie Defense." In

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

court, defendants may stand behind a theory of the case called the "Twinkie Defense." This theory tries to throw the jury off the trail by blaming the client's bad actions on so

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

Professional from academic institutions, pharmaceutical industries, health care indust

ething else - he ate too many Twinkies, for instance, and was on a sugar high when he killed/robbed/raped/molested and therefore is not responsible for his actions. You may have en

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

countered the Twinkie Defense with your employees: "I was late because traffic was unusually heavy and then when I got here the elevator was broken, therefore my tardiness is not

.

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

my fault." Decide that employees will be held accountable for their actions and don't allow them to hide behind the Twinkie Defense. In response to the Twinkie Defense, you respo

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

Companies that provide selfless information through particip

nd with, "This is about individual responsibility - not trying to hide behind excuses."

Deploy these field-tested and proven strategies and you’ll be coaching employees like a pro

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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