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“Mommy, Mommy, Mommy! Am I stupid?” excitedly requested Christopher, nearly out of breath from the long run into the kitchen. She knew he had been playing with neighborhood children under a mighty pine tree in the side yard.

Saddened by the question

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

and realizing he had just been tormented by the others, she tenderly gave him a hug and lovingly told him, “No, Christopher, you are not stupid.”

“Oh,” replied Christopher, with obvious disappointment in his tone.

Certainly you must be wondering wh

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

Examples of combination products may in

these loving words of motherhood would be met with such sadness. You see what had really happened was that as the children were teasing him about his autism they were really paying attention to him. He was the center of their focus and for a brief

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

moment he felt like he was accepted by them. He felt special. His value as a human had astronomically increased because he was, as they put it, “stupid”.

As Christopher grew he understood the lesson he learned that summer afternoon better than most

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

eople ever do. He understands that he is different, but that it is okay to be different. Now a teenager, Christopher sees himself as an individual that has value. He knows that even though he may be “stupid” in many people’s eyes, he is an individu

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

Combination pro

al with special traits and talents that excel above those same traits and talents in “normal” people.

During his work training class at Rochester’s Stoney Creek High School, Christopher has proven these talents. During his assignment at Mr. Pita eve

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

y take-out bag was exactly the same: neatly bagged pickle, napkin, and utensils in the exact arrangement he was first shown. At Rochester’s Dillman & Upton Lumber each tube of caulk was placed on the shelf with precision – label facing out and in th

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 proper slot for the brand and type. And in his semester at Duke Humphries’ Grill, luncheon diners would see every place setting in perfect match and each salt and pepper shaker filled to precise spot Christopher has been shown.

Despite this unquen

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

hable desire for perfection in the accomplishment of routine tasks, thousands of people just like Christopher have another label placed on them today: “unemployable”. When the economy is strong and unemployment is low, employers find autistic workers

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

to be among their best. However in an economy where every worker must market themselves to beat out dozens or competitors for the few available jobs, the autistics lack the polish and credentials of the more traditionally groomed candidates.

It see

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

s employers quickly forget the advantages of autistic workers when it comes to repetitive tasks. Those with autism possess an uncanny ability to focus on their work and perform the repetitive tasks with tremendous accuracy and reliability. They are

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

Following aspects would a

also extremely loyal workers, unlikely to jump ship because they can earn a quarter an hour more at another employer.

The Federal Reserve board is reporting “fresh momentum” in all 12 surveyed districts across the nation. This is an early indicator

dd to the challenges in developing combination products:

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

of economic conditions that will change the current employer’s market back to the employee’s market. Along with the change will be a return to the problem of employee retention. Gallup shows nearly 50% of employees feel disconnected from their emplo

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

er and BostonWorks.com finds that only 43% of employees are satisfied with their current employment situation, down from 50%. According to BostonWorks.com president, Peter North, many employers are misled by the fact that their current retention is l

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

ow. These three facts point out that the marketplace will soon return to an employee’s market and up to 57% of employees are likely to change jobs.

Given these facts the smart employer will begin to prepare today for this shift. They will do so bec

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

use even if the shift does not occur the analysis will provide for a stronger, more productive workforce. The even smarter employers will look for ways to combine tedious functions or repetitive work into jobs for autistic Americans. By seeking out

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

Professional from academic institutions, pharmaceutical industries, health care indust

these tasks and combining them into special jobs they establish a core group within their organization to do these tedious jobs effectively and joyfully. They will also find a core of loyal employees for many years to come.

Being a leader means maki

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

g the choice to do what is right for the long-term good of a company or organization. When a company can hire someone unlikely to leave their employment, they have reduced the future hiring and training expenses. A real leader takes this into accoun

.

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

t. When they do, it helps the handicapped to offset the stigmas associated with their disability.

For more information about hiring workers with disabilities, contact New Horizons or the Jay Shops in Pontiac, or Community Mental Health Services in A

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

Companies that provide selfless information through particip

burn Hills.

Rick Weaver is President of Max Impact, a leadership and organization development organization based in Rochester Hills, Michigan. Contact Rick at 248-802-6138 or visit their website: www.getmaximpact.com. Rick is also Christopher’s Dad

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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