Subjects - Business

Many of you conduct year end performance evaluations with your employees. In this article we will presume that these have been positive experiences for both you and your employee and that you mutually agreed upon opportuni

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

ties for growth, development, and improvement. As you look back over the past year did you see progress toward the achievement of those opportunities or did the employee start off enthusiastic but soon returned to the old

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

Examples of combination products may in

ay of doing things or behaving? Are you wondering why? Well first let’s agree that nearly every employee truly wants to do a good job and gain the approval of their employer. Those rare birds that don’t are another discu

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

ssion entirely. That means that when employees aren’t giving us what we ask of them we need to evaluate our systems and pinpoint the systemic problem. So what could possibly be wrong with our performance evaluation proces

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

?

Given that only 3% of the entire population knows how to truly set and get goals, goal getting may be a big part of the problem. If you and your employee(s) haven’t truly established a plan, you have a low probability f

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

Combination pro

or success. So let’s review how to help your employees get their goals. One of the most important elements is making sure that the employee writes their own goals. They need to own their goals. That will never happen if

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

you or someone else sets their goals for them. Here are some guidelines to help your employees move closer to goal getting:

1. Written – Have the employees make sure their goals are written, specific, measurable, achievab

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

le, challenging, and that you have a mutually agreed upon target date. Now is the time to get them to come up with goals that will enable them to contribute to the overall organizational/departmental plan.

2. Balance – En

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

ourage them to establish goals for their personal life as well. This will help them to achieve balance in their lives so that they don’t burn out and get frustrated from feelings that their entire life revolves around thei

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

r job. As I work with my coaching clients we often discover that when the wheels seem to be coming off their cart that a lack of balance is the source or their difficulties.

3. Avoid Procrastination – People procrastinate

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

because of fear of change, fear of success, or fear of failure. When you see the employee has fallen off the path, don’t wait immediately set time aside to talk with the employee and determine whether fears or other obstac

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

Following aspects would a

es are standing in their way. Then work with them to remove either the fear or the obstacle.

4. Break it up – Often times in our excitement to make dramatic improvements we confuse goal categories with individual goals.

dd to the challenges in developing combination products:

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

For example, if the goal category is improved sales an individual goal might be to hold six appointments each week with qualified prospects. Starting and succeeding with the critical small steps builds the skills and confi

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

ence needed to achieve the bigger things.

5. Positive affirmations – Positive affirmations keep you focused on positive attitudes and results. In one mid-sized insurance group I know the agents shout out their positive af

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

firmations each morning in their offices to both keep themselves self-motivated and to inspire others in the group.

6. Obstacles – Help the employee to foresee and forestall the obstacles that could stand in their way. Wr

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

te down each and every obstacle and come up with a plan for how to either avoid or overcome that obstacle. If an obstacle is related to lack of skill or knowledge on the part of the employee, plan how the employee will att

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

Professional from academic institutions, pharmaceutical industries, health care indust

ain the needed skills/knowledge.

7. Check-up – Performance evaluations shouldn’t be a once a year event. From the onset plan when the two of you will get together next to discuss progress or difficulties. Let the employe

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

know that you are always available to talk about their difficulties and the unforeseen circumstances that are causing them difficulties. Brief quarterly discussions are a good idea. Remember to encourage their efforts an

.

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

d to act as their support partner to help them overcome their challenges.

These brief guidelines will put your employees on the path for goal getting and enhance their self-esteem and the work relationship between the two

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

Companies that provide selfless information through particip

f you. We all appreciate a partner in our corner striving to help us to be our best. This approach puts you on the same side working toward the development of empowered and self-motivated employees that excel in their job

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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Online incorporation lets you form a company in just a few minutes. All you need to do is fill in personal information and the online incorporation service provider does the rest. But owing to the innumerous online incorporation service options available, it becomes difficult for the customer to get one that does the job right.

When most people think of engineering they think of building bridges, roads, buildings, and that sort of work. Most people, however, would never think of audio engineering. This is a very real job and has some very successful people working in the business.

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