Subjects - Business

One of the most difficult and emotionally draining situations you face as business owners or executives is employees not meeting your expectations. How can

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

you handle it if they are not keeping up their end of the employee contract?

Begin by taking a look at your team. Do you have the right people? Before

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

Examples of combination products may in

you hire someone, think about the culture of your company, the team that you already have in place and your particular style of management. If you have a v

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

ery structured environment, then you’ll want to hire people who can fit in to your more disciplined atmosphere. If you have a very entrepreneurial company t

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

en you’ll want people who are more independent. If you have talented people that fit your company culture, there’ll be less of a gap between your expectat

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

Combination pro

ions and their performance.

Now that you know you have the right people and you want to narrow the gap between expectations and performance, here are four s

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

uggestions:

1) Be clear about your expectations.

Do your employees know what is expected? Have you fully acquainted them with your vision and desired ou

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

tcome? Don’t assume they know what it is. Communicate clearly. Once the employees knows what the vision is and you’ve been clear about your expectation

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

, then let them take responsibility for achieving the goals. Your responsibility is to keep everyone’s focus on performance, but don’t expect them to do it y

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

our way.

2) Make sure they have the tools and information they need.

This is usually the most clear-cut reason for poor performance. Is your employee a

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

fraid to let you know that she doesn’t have the knowledge, tools or information she needs? This can be a tremendous time waster. Make sure you’re approach

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

Following aspects would a

able and then provide the training needed. Only training can close this part of the performance gap.

3) Get to know your employees well.

Know their par

dd to the challenges in developing combination products:

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

icular skills, talents and needs. Know their strengths and development opportunities. Frequent meetings make it much easier to confront the employee with t

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

he gap between her performance and your expectations. Keep the communication lines open and be candid. If they aren’t on the right path, it’s important to c

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

ommunicate that in a timely manner.

4) Concentrate on the future.

Once you and your employee have identified the gap, and you both understand the reason it

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

occurred:

a) Ask how she plans to accomplish her objectives.

b) Ask her what she needs from you.

c) Instruct her to set up a progress check. This pro

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

Professional from academic institutions, pharmaceutical industries, health care indust

ess will lead to her being more invested in the results and realizing her own strengths.

Wait…..there’s just one more thing. What if you’re reading this an

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

d you work for a manager who is still a “work in progress”? What can you do?

•Ask for more frequent meetings;

•Inform your manager of what you think your o

.

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

bstacles might be.

•Inform your manager about your needs for mentoring or training.

•Inform your manager of your ideas for success.

None of this is easy; b

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

Companies that provide selfless information through particip

eing a good manager and a good employee is hard.

The road to making it easier is paved with both good intentions and good follow through.

© 2005 Julane Bort

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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Getting selected in a job interview is only half the job done; the other half is salary negotiation. When negotiating a salary, timing is important. Asking the salary amount right in the first instance would be imprudent. It is important to get the job offer or reach the final interview first before negotiating the salary-

Handling any sort of conflict requires you to draw on all your resources. In particularly your communication skills. The reality is that we all have many communication skills but don’t always use them effectively and certainly we do not take the opportunity to improve them as often as we should.

Are you monitoring the results of your management team? Are you charting the progress of your organization? Are you paying attention to the organizational capital, which comes thru working thru crisis and achieving results?

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