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The single greatest obstacle preventing organizations from becoming great–achieving superior results, exceeding customer expectations, attracting and retaining talent, developing

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

leaders, and creating work environments where people at all levels can learn and grow and prosper is painfully simple: Management Malpractice—abuses of power, knowledge and rela

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

Examples of combination products may in

ionships that bog down systems, frustrate people, thwart teamwork, divert focus, and compromise results. What exactly is management malpractice? Any organizational practice or ac

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

ivity that makes it difficult for people to perform their jobs, develop themselves, coordinate with others, find fulfillment, create value and get results for themselves and thei

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

organizations. It occurs when management principles or corporate values are preached but not practiced and always involves an abuse of power, knowledge or relationships. Managem

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

Combination pro

nt malpractices at all levels in an organization must be constantly exposed and routinely eliminated if the enterprise expects to achieve and sustain greatness.

Great management

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

principles that are considered by most people to be timelessly and universally true — principles such as sharing ideas at every level, fostering a healthy dissatisfaction with 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

status quo, treating employees as your most valuable asset, valuing the contributions of each individual, creating an environment where people feel free to raise concerns, estab

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

ishing a foundation of respect and trust, enabling people to tap into their full potential, listening to all viewpoints, constantly challenging assumptions and biases, and accept

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

ng responsibility for your actions — provide a vital shield and protection for individuals in organizations. When such universally accepted principles and truths are ignored, for

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

otten or preached but not practiced, individuals lose their protection and become subject to managers and leaders who can easily manipulate, abuse and injure them. Just as a nati

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

Following aspects would a

n without the rule of law cannot protect its citizens from physical harm, an organization without the rule of great management principles cannot protect its employees from emotio

dd to the challenges in developing combination products:

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

al and psychological damage. Management malpractice occurs whenever managers and leaders fail to apply principles that have been tried and tested, proven and accepted as timeless

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

y and universally true.

Oftentimes a vicious cycle is at work in organizations: leaders consciously or unconsciously malpractice management, employees react with disappointment

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

nd disgust, leaders attempt to correct their malpractice, employees perceive leaders’ corrective efforts as disingenuous and manipulative, leaders react with disappointment and d

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

sgust but they try again, employees cautiously give leaders another chance, leaders improve but not as fully and quickly as employees would like, employees become angry and call

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

Professional from academic institutions, pharmaceutical industries, health care indust

eaders hypocrites, leaders become angry and call employees whiners, and so on until both leaders and employees accept management malpractice as the norm. It is an inescapable rea

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

ity of modern organizational life.

This vicious cycle continues until the organizational culture becomes mired in cynicism and distrust. The solution? Break the cycle by seeing

.

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 and exposing it – both the leader’s under-reaction to malpractice and the employee’s over-reaction to imperfection. Only when management malpractice is replaced with a widespre

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

Companies that provide selfless information through particip

d adherence to great management principles (timeless and universal) will the labels of hypocrite and whiner disappear. Only then can the vicious cycle be prevented from returning

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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What keeps companies focused is attention to the right things as modeled by its leaders and practiced by every employee, every single day. You cannot store attention.

It is said that variety is the spice of life. In most businesses, including healthcare, standardization of common processes produces the best results. Mr. Bryant discusses why you should standardize, gives you some expamples, and tells how to measure it.

Employee salary surveys are conducted by organizations to determine the latest trends in salary and compensation. This is very useful, since companies can set their own salaries on the basis of these results. This would enable the company to attract as well as retain the most talented people in the industry.

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