Cases - Business

Many of the stereotypes of companies are true. Companies often hire inexperienced workers for low pay, don’t train them and then wonder why they get poor perf

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

ormance.

Companies don’t sufficiently include their employees in the creative idea process or give attention to individual input. They continue to enforce hi

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

Examples of combination products may in

her production requirements with tighter deadlines – in effect, expecting a “worker bee style” from its employees to keep up with competitive needs. Staff has

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

little promise of promotion in this time of cutbacks, and consequently no real cause for ownership, since they are simply expected to get the job done. Yet c

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

mpanies feel cheated if they don’t get the quality work they expect from their workers. They complain that childcare options, flex hours, appreciation luncheo

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

Combination pro

ns, sick leave and annual cost of living increases are frequently disregarded.

Employees feel under appreciated and un-challenged and that constant complaint

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

revents stepping up their performance. They justify doing personal projects on company time since the hours at their jobs are often extended - never mind that

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

it’s often due to their undisciplined and unfocused work habits. Employees feel the inequity of being asked to assume leadership roles, if it means increased

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

workloads with little to no reimbursement incentives. Employee theft has increased, a contributor to downsizing and cutting costs due to lost revenue. Longev

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

ity and loyalty are quickly fading concepts of the past.

To guarantee results, management has needed to adopt back up systems. Divisions of quality control a

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

d customer complaint departments are needed to fix what wasn’t done right in the first place. Numerous policies and guidelines are imported, including those o

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

Following aspects would a

fair practices and ethics. Micromanagement is implemented to double-check work product and enforce behavioral operating rules that should be a natural mode o

dd to the challenges in developing combination products:

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

f operation for us all. Taking personal responsibility has decreased. We have backed into corners like boxers duking it out till we settle on who is to blame

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

for the system not running more smoothly.

Does the burden rest on companies to produce more inspired, trained and challenged employees or to the employees to

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

be more self-directed and generative? Both must share in the responsibility of improving work environments with more harmonious relationships, mutual respect

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

nd acceptance of individual and company needs. Like the proscenium arch of a theatre’s stage, if only one column gets moved forward, the arch will fall. By m

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

Professional from academic institutions, pharmaceutical industries, health care indust

oving both apart at equal distance the structural support necessary to hold up the archway remains.

I hope this article starts the cycle of recognition. That

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

is always the first step, then there is more dialogue and brave first starters. Look at Ben & Jerry’s and The Body Shop who were willing to experiment and clo

.

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

se the employee-employer gap. But why wait for others to act on external big changes? You can implement changes now if you’re willing to stick out from the r

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

Companies that provide selfless information through particip

st, generate discussions about what’s missing and possible solutions. Be one of the first to put an end to the right-wrong game we’ve all become accustomed to

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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So, how satisfied are you with your career on a scale of 1 to 10, with 10 being extremely satisfied? If your answer is 6 or below, what needs to change for your career to be a 10? Will you spend another year hating your job or will make a change so that you’re loving your life?

You spend years building up a successful cleaning business. And, unfortunately, in just a matter of minutes it can be wiped out by a disaster - fires, floods, tornadoes, hurricanes, and chemical spills are just a few of the things that can wipe out your business in a matter of minutes. How you prepare ahead of time can determine if your business succeeds or fails after a disaster happens.

Confused about the difference between DMADV and DMAIC? This article cuts to the chase and shows you which one to use and when!

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Cases - Who Is to Blame for Job Dissatisfaction?

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