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Are there different types of organizational transformation? In our work as internal and external consultants over the last twenty years, we have seen four distinct types of o

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

rganizational change.

Don't Upset the Applecart With this type of change, you merely calibrate or tweak some aspect of the current system. It is very restri

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

Examples of combination products may in

ctive in focus and perpetuates much of the old, and in some cases, flawed system. Since it is a relatively low threat and painless change, it has limited effect on the employ

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

ees’ mind set, and oftentimes, does not allow much, if any, transformation to occur.

Boomerang This type of change is common in organizations of all types a

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

nd sizes. It is reactive and responsive to both internal and external forces. This type of change is problem-focused, with very clear objectives and outcomes. Because there i

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

Combination pro

no built-in mechanism for perpetuating the new way of doing things, organizations more often than not fall right back into their old habits and practices. You throw out the

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

old way of doing things, but the old way comes back, just like a boomerang.

Boil the Ocean This type of change and transition seems to be surfacing due to t

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

he rapid changes in our economic system, stock prices and market fluctuation, rampant M&A activity and a vast amount of changes in top leadership positions. With the Boil the

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

Ocean approach to organizational transformation, companies are constantly trying to harness and grasp all change and transition activity in one fell swoop. This approach is

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

costly and dangerous. Taking on too much at one time weighs down and drains the energy from the organization than a more focused piece by piece approach would do.

Co

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

scious Creation This is the most effective type of change. It involves a gradual metamorphosis. Because this is not a superficial process, this type of change typica

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

Following aspects would a

lly causes a high level of pain on the front end. However, the rewards (creating a culture that is resilient and can handle change) are worth the effort and energy, because y

dd to the challenges in developing combination products:

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

ou will create a new culture in which change becomes relatively painless.

Conscious Creation comes about through true commitment and thorough understanding of how each chang

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

e initiative (whether it happens at the departmental level or at the corporate level) affects the whole system.

A well-orchestrated plan is crucial and involves a significan

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

t portions of employees at all levels. This type of change initiative is much broader and has a significant impact on changing the mind-set and behaviors of the entire work f

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

rce. EMERGE International focuses on helping organizations achieve this kind of change.

Interested in learning more about organizational transformation? Vis

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

Professional from academic institutions, pharmaceutical industries, health care indust

it us online at www.emergeinternational.com or email us at info@emergeinternational.com for more information.

About EMERGE International: We believe in creating healthy and

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

productive work environments. In fact, since our inception in 1996, we’ve dedicated ourselves to it. At EMERGE International our focus is to ensure that our holistic approach

.

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

and validated assessment tool, the Cultural Health Indicator™ (CHI) is accessible to the widest range or organizations possible. From self-service models to full-service con

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

Companies that provide selfless information through particip

sulting, we have a range of options to meet every project requirement that are on time, on budget, every time.

EMERGE International is a WBENC certified woman-owned business

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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Substation operators, also known as switchmen, are in charge of the monitoring of the machinery that distributes electricity to residential, business and industrial areas. They operate in electrical substations monitoring equipment that increases or decreases voltage. They have to check the electric substations throughout the country to check charts, oil levels in equipment, temperature changes, load conditions, oil leaks, and any irregularities. In addition, switchmen have to operate switchboard levers to control the flow of electricity in and out of the substations. They are working closely with power generation operators and transmission engineers in order to anticipate and solve the change in power needs. If the power requirements change, substation operators have to start or stop distributing lines and switch them between the circuits.

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