Advice You - Business

One of the most effective ways to improve mental and physical health is rest. People also produce their best results when they are relaxed and comfortable at their workplace. The first conce

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

pt of rest in the corporate context is stability. Therein, lies an apparent paradox. To cope with the rapid changes, the company needs to change. Yet, in the quest for growth-inducing change

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

Examples of combination products may in

, the company needs to have rest and stability. It is the same with the human body. A company needs some amount of organizational slack or thinking time. Many companies focus on changes afte

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

r changes except they forgot that the things that they are currently doing are just as important. As a result these companies went through fruitless diversifications and divestments. Finally

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

they ended up losing focus or neglecting their core businesses because they did not protect their fortresses back home.

Times of stillness during rest facilitate a shift of focus from being

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

Combination pro

immersion in one’s stressful environment to a more tranquil state of mind. This will not only allow one to cope with the onslaught of stress but also enable the mind to be energized and r

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

juvenated while emptying the negative emotions accumulated throughout the day, week etc. The body needs rest in order for it to re-charge and repair itself. It needs time to relax, think and

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

reflect back. But at the same time, the body needs to remain active in order to achieve optimal body functions and good health. One cannot remain inactive or passive indefinitely. Otherwise

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

prolonged periods of inactivity can result in the loss of mental lucidness and thereafter a steady decline in one’s body functions and health. It is found that people who retire and do not

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

keep active, often die shortly.

This is why the turnaround manager has to master the art of preserving stability amidst change as well as spurring change during stability

Managers think that

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

if the staff take things easy and relaxed, they are goofing off. This is not true. Most creative ideas and innovations come about when the person is relaxed. When he is tense and over-crowde

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

Following aspects would a

d in his mind, he has no time to truly think. How can then the creative juices be generated?

Change can create workload and stress to the staff. If the change is well managed to bring in be

dd to the challenges in developing combination products:

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

ter processes and increased efficiency, then it is justifiable. However, if the changes come frequently and constantly with little respite, then the workload can bring stress and detriment t

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

o the individual as well as the organization. Prolonged stress can result in high employee attrition and customer service deteriorates.

It is therefore abhorrent to hear a manager say: “Firin

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

shall continue till morale improves.” Some companies hire and fire whenever they like. This is binge-and-purge staffing or corporate bulimia, an illness in which there is a great and uncont

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

rollable desire to eat, usually followed by vomiting in order not to gain weight. Such frequent changes in management and staff not only breed suspicion and disloyalty among the staff but al

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

Professional from academic institutions, pharmaceutical industries, health care indust

o rip off the innovative heart and fabric of corporate cohesion. Frequent changes through downsizing exercises have proven to be a corporate cultural disaster. Self-interest will replace c

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

orporate interest, as loyalty and trust are lost.

This is why Lewis Platt, the former Chairman and CEO of Hewlett-Packard said: “There are times when the right strategy is probably to back of

.

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

on current growth in order to have the company better positioned for the future.” Rest, you cannot afford not to. The time to rest is when you do not have time for it.

This is why there is

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

Companies that provide selfless information through particip

a saying: “God grant me the serenity to accept the things I cannot change, courage to change things I can, and wisdom to know the difference.” This is why you need R&R – Rest and Rejuvenate

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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