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When stress runs out of control it leads to burnout. No news that this is a workplace problem. Every increase in productivity comes about not by magic but by effort and intensity. The workforce pulls together, works har

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

d, puts in long hours and concentrates. The standards are set high. Of course there is stress.

What is news, however, is that stress can lead to the loss of the highest motivated workers, managers and executives. The 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

sumption would be otherwise. One would think the highest motivated people, especially among the ranks of managers and executives, would be the ones with the most staying power. But stress allowed to run out of control a

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

lways goes in the same direction: burnout.

There are five types of burnout:

Leaving the profession forever

Above it all

Trapped in a gilded cage

Dead wood

Helpless and hopeless.

The highest mo

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

ivated persons are usually in the operation because that is what they love. These persons are easy to spot when they interview. They are the ones who always wanted to be a teacher, a minister, a doctor, a nurse, a compu

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

Combination pro

ter whiz, a programmer, a scientist, an engineer. They read books and watched movies that portrayed what they dreamed of becoming. They worked hard at school. They went to college or technical school to achieve a founda

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

ion for what they planned on doing all their life.

These persons hit the ground running when they are hired. They come early, stay late, work during breaks, ask questions and emote enthusiasm. Sometimes they give union

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

stewards a headache because they set the bar too high. They are not necessarily popular with coworkers or co-managers for the same reason. They may be respected but also resented. If you put them in charge of company e

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

ents they will push, pull and prod everyone else into doing their part and more.

These are the mechanics who take the manuals home to study in their spare time. These are the teachers who come back on weekends to make

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

their classrooms and labs more learning efficient. These are the persons who are happy to be doing what they are doing because it is their dream come true. They give it their all.

Therein lies the problem: they know no

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

restraint and cannot pace themselves. They are like a plane going full throttle all the time, one speed only. In the beginning they usually get encouraged by whoever is in charge. Eventually they get feedback about paci

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

Following aspects would a

ng themselves and giving it a rest and thinking about the long haul. Good advice: those who hear it do well over the long haul. Those who ignore it mistake the advice as temptation to become mediocre. They misread and m

dd to the challenges in developing combination products:

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

sintrepret the hints to slow down as signs of apathy.

They have embarked on the burnout path leading to Leave The Profession Forever.

The journey is swift and often ends abruptly. Like a flaming meteor, they cr

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

ash, exhausted and disillusioned. The very ideals which brought them to their dreamed-of work become the reason they leave forever. The explosion might be a tirade against the company, the industry or the coworkers. The

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

bitterness may be over feeling used. The perception might be that the whole outfit lacks vision and integrity. They leave forever, often turning on the very people at the top who are first were thrilled to have them on

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

board. The company or oganization loses one of its most valuable people.

Such tragedies are easily avoided with a few sound practices revolving around supervision and mentoring. These are the racehorses who should be e

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

Professional from academic institutions, pharmaceutical industries, health care indust

couraged and taught how to pace themselves. Their zeal should be tempered, not rewarded. They should be paired with experienced people and mentored to fit into the pace instead of trying to outrun everybody around them.

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

They should not be allowed to skip vacation. They need to leave work at work and quit at quitting time. When they are sick they need to take sick leave. When they volunteer for extra duty they should be thanked but req

.

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

ently refused.

If you as a manager or executive happen to be on the path leading to this type of burnout do two thing immediately. First, take some vacation time. Then find a mentor or get some executive coaching. Your

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

Companies that provide selfless information through particip

challenge is to achieve perspective, something which calls for talking with someone else who has perspective.

Productivity is important but it should never be achieved at the expense of the people who make it possible

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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There’s no harm in going ahead and answering the questions, but you’ll want to keep your answers brief. For example, if an interviewer asks you “How does your wife/husband feel about you taking this position?” then you could answer – depending on your marital situation — “She/he is fine with it” or “I’m not married.” There’s no reason to go into any further details, such as how long you’ve been married or if you’re in a serious relationship.

Small business start-up rates are at record levels; so are failure rates. There is a definite pattern to failure rates. Initial growth of small business often plateaus because of a lack of corresponding growth in basic management skills. Entrepreneurs must shift their thinking from tactical and operational to strategic and supervisory. Entrepreneurs must become professional managers or suffer poor business performance, even failure. Growth in sales and employees must be accompanied by corresponding growth in management skills. Systems, procedures, tools and training already exist that can be quickly adapted to small businesses at low cost.

There are some very interesting fundraising organizations on the market today. If you are looking to pull off any kind of successful fundraiser you would be...

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