Useful Advices - Business

Feedback in business is a collaborative process of two-way communication between management and employees. Too often, input fr

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

om a manager doesn’t come until it’s time for a performance evaluation or when a problem has escalated out of control. In eith

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

Examples of combination products may in

er scenario, the time to offer constructive feedback is often long overdue.

A good manager understands the value that ongoing

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

communication holds in the development of their team. Proactive input, whether positive or negative, is essential, and if hand

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

led properly, builds trust and respect throughout the team. The goal is not just to solve a problem, but rather to help the em

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

Combination pro

ployee grow both personally and professionally.

Sally’s Five Growth-Proof Steps to Constructive Feedback

1. Plan It Ou

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

t! Often, employees worry for days about feedback but most managers spend little time thinking through what they want to accom

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

lish with their feedback. Take time to think through the message you want to get across to an employee by outlining your thoug

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

hts with specific examples of the situation you’re trying to change.

2. Own It! Focus on your personal perception of the situa

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

tion, rather than what the person did wrong, and address the receiver with facts, rather than assumptions and hearsay. Instead

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

of saying “You were wrong to speak out in the meeting” say “When you spoke in the meeting, I felt that you were very angry abo

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

Following aspects would a

ut the situation.”

3. Ask for It! Allow the receiver the opportunity to explain. Most managers spend too much time talking i

dd to the challenges in developing combination products:

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

n feedback sessions. Your employee deserves a chance to react to your perceptions and explain their perspective. This input wi

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

ll be important in helping the employee move beyond the situation.

4. Map it Out! Develop a plan to help the employee correct

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

and move beyond the situation. Addressing the situation is a first step in the process, but most employees want to know how 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

improve and what you, as the manager, are willing to do to help them.

5. Sum it Up! Now that you’ve offered constructive fee

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

Professional from academic institutions, pharmaceutical industries, health care indust

dback, recap the outcome of the conversation in a one page summary, outlining the circumstances and next steps, including a fol

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

low up date and how you’ll measure their progress.

Taking time to both think through and clearly define your message and the d

.

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

esired outcome ensure that the employee understands your concerns and that they have the support needed to progress. Providing

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

Companies that provide selfless information through particip

candid and frequent feedback is a necessary process in one’s professional development. You get out of it what you put into it

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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