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It really pains me when leaders talk about employees who don't perform to minimum standards. It seems that rather than take on the problem, leaders often find it easier not to confront the issue. A big par

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

t of leading people is helping them understand when they are doing well and not doing so well. It is especially important to recognize someone at once when they are doing a good job. When they need to impr

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

Examples of combination products may in

ve, your job is to coach them to better performance.

Some keys of coaching are: 1. Information: Know what is going on with your staff 2. Listen with empathy 3. Be aware of the work environment. This comes

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

from talking to people 4. Instruct staff so they know exactly what is expected 5. Giving feedback

Good coaches are good role models. They demonstrate good work habits. They also get to know people well e

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

ough to be able to develop them appropriately.

Coaching is situational. You take different approaches depending on the employee and their overall competence and experience, as well as ability to do a spec

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

Combination pro

fic task.

Look at the grid.

Grid I: Competent and task experienced There is no problem with employees in this box. Little follow up is needed here because the employee is dependable and

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

good at his/her job. Though little follow up is needed, it is always wise to show appreciation for these gems! A verbal "attaboy" or "attagirl" is good and a written memo is even more memorable.

Most peop

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

e I question about receiving written letters or memos telling them they did a good job say they still have those notes years later. Remember that it only takes a few moments to put your appreciation in wri

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

ting.

I. Experienced at task and Competent overall No Problem: Keep in touch, but let employees do their job. Little follow up.

II. Inexperienced at task and Competent overa

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

l To avoid problem: Check up and coach by giving H.E.L.P. Some follow up.

III. Experienced at task but Incompetent at task Fix Problem: Coach and D.E.A.L. w

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

th problem. Follow up often.

IV. Inexperienced at task and incompetent at task Fix Problem: Train or retrain. Follow up often.

Grid II: Competent, but task inexperienced

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

Following aspects would a

If the employee is having difficulties with the task after you've given instructions, you can avoid problems by coaching him/her with H.E.L.P.

H= Hear problem. Listen to your employee's view abo

dd to the challenges in developing combination products:

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

t the task and state your own view. E= Encourage by asking open questions to learn more. Get details about the situation causing the problem. Discuss the task until there is mutual understanding of problem

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

. L= Lead employee to come up with his/her own recommendations about what to do to solve the problem. P= Praise employee for his/her problem solving ideas. Follow up occasionally to offer resources and add

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

tional help, if needed.

Grid III: Experienced, but incompetent You need to fix this problem! The employee has been trained and retrained, yet still is performing below expectations. Befor

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

giving up on them, D.E.A.L. with the problem.

D= Describe the situation without getting personal or blaming. Be specific and objective about situation, not the person. E= Express your feelings. "When thi

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

Professional from academic institutions, pharmaceutical industries, health care indust

s happens, I am concerned (or frustrated) because we are not meeting customer expectations" (or wasting time and valuable resources.) Do not start sentences with "You always" or "You never." The employee w

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

ll become defensive and argue with you. A= Ask for what you want employee to do. Be specific with deadlines and checkpoints. L= Leave it on a positive note. Be encouraging and expect good results. Be motiv

.

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

ating rather than demanding.

Follow up frequently. If employee still fails, it is time to stop coaching and start disciplining.

Grid IV: Inexperienced and task incompetent Make this a tr

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

Companies that provide selfless information through particip

ining or retraining issue. Be specific about instructions and ask employee to repeat them to be sure he/she understands what is expected.

With these coaching ideas, your job as a leader will become easier

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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Many businesses can not afford to lose valuable customers due to the smoking ban in the United Kingdom. A business wants to offer an area that is comfortable and safe for smokers to enjoy their cigarettes in. Plus a business wants a convenient way for smokers to properly dispose of their finished cigarettes. A budget smoking shelter with a curtain is the solution to the smoking ban. This type of smoking shelter is affordable for a business working within the tightest of budgets.

Through observing business people who have been successful, and how they achieved their success, I have concluded that there are a number of factors that must be present for business success to occur.

There was this company that was called Ecoenergizer, that started up shortly after the Texas Attorney General shut down Bioperformance (Bioper. in my option was one of the better products on the market at that time that worked really well) because the Attorney General claimed that the product was nothing but moth balls. This in my opinion is BS because I used it in my truck for 15,000 miles and got good gas mileage with that fuel Saver product

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