Social Space - Business

Work/ life balance as we know it at present isn't working, because it's based on conflicting demands of employer and employee for a share of the 24/7 day. There simply isn't enough time to achieve ev

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

erything - and its getting worse.

Work life balance suggests people are living two lives - one at work and one away from work. But people don't ‘work' for five days (or more) and ‘live' for two days

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

Examples of combination products may in

(or less). Work is just one of many roles that people perform in their 24/7 week. No matter where they are or what they are doing, day or night, people are carrying personal baggage, problems, respo

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

nsibilities, personal goals and work goals. Separation of work and personal life roles has become a blur and, to many of us, almost a seamless link..

Family-friendly policies are now only one aspect

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

of the work life balance issue. Work life balance has become a key factor in attracting and retaining good staff (male and female) in a ‘buyers market' generated by a shortage of quality skilled staf

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

Combination pro

f. People want more than money. They want quality of life, of which a quality working environment forms only one (albeit important) part.

This situation has arisen for a multitude of reasons, not th

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

e least of which was because businesses in western society found permanent staff to be too expensive and resorted to down-sizing and outsourcing. Workers had to learn to manage their own lives; work

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

ife balance is now finally determined by the employee rather than the employer (to be effective, it of course cannot be decided unilaterally but by co-operative agreement between employee and employe

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

r).

Globally, business has had to come to terms with the fact that, while economic growth depends on the work ethic, employees are now opting for what I call a “life ethic”. Features of this ethic i

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

nclude:

• working to live, rather than living to work,

• personal goals being a higher priority to the individual than the employer's corporate goals and

• emotional needs as the determinant of ma

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

erial needs.

Business therefore is finding it has to seek ways of harmonizing corporate goals of economic growth with individual philosophies of “I'm here for a good time, not a long time”. This see

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

Following aspects would a

ming dichotomy is frustrating older managers greatly, but emerging generations of employees don't see it as a problem. They still see work as important but only as a means to higher, more personal, e

dd to the challenges in developing combination products:

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

nds.

Harmony is drawn from diversity. A choir or orchestra is a ‘mosaic' of unique individuals who come together periodically to produce a pleasing sound. Business has to find ways of maximizing the

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

unique interests and potential of employees to achieve its own 'pleasing sound' - usually in the form of a quality service to customers and a satisfactory financial bottom line.

Sustained long-term

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

business success is going to increasingly depend on employers and employees working together to develop a workplace culture that encourages a harmonious relationship between the personal goals of ind

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

ividual employees and the corporate goals of the employer.

Here are some initial steps you can take towards developing a Work Life Harmony strategy in your business:

• for the purposes of the strat

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

Professional from academic institutions, pharmaceutical industries, health care indust

egy, regard the organization as a totally flat structure with all people on the same line and of equal importance regarding work life harmony issues (the CEO is as interested as anyone else in qualit

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

of life and various work and other roles he/she performs):

• arrange round-table discussions between groups of people from all levels of the organization, on issues that are presently inhibiting a

.

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

satisfactory work life harmony culture in the organization,

• group recommendations towards a strategy that sets out actions in the following order:

o issues that can be most readily resolved with

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

Companies that provide selfless information through particip

the least effort and cost,

o more difficult issues that require more time, effort and cost to be scheduled for attention in an agreed order and over a period of time up to, say, three years maximum

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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