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Managers fall into a trap, quite easily when the pressure is on, of doing more of the regular workload that their employees could. It makes them feel like they are achievi

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

ng more personally, as well as fighting the fires that crop up every day. But this is not a sustainable solution, here's why...

Most managers are measured on tangible res

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

Examples of combination products may in

ults. It could be sales, or response times or production output. It is often number related and with this in mind, many managers seek to beef up the manpower delivering th

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

ese numbers, by doing some of this work themselves.

There is nothing wrong with a manager choosing to get their 'hands dirty'. To chip in with their people. In fac

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

, when it really matters, it can be a valuable motivational activity, building team spirit.

But as resources get stretched and the manager becomes an integral part of the

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

Combination pro

workforce, the business starts to get dependent on their tactical input.

And this stops being a management role, but a 'doing' role. At it goes on and on, with no time t

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

o develop people and strategies to make the business truly grow, develop and evolve. There is no time for the really important stuff which grows teams and individuals to i

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

prove and enhance their contribution.

And so the problems start.

Firstly, the manager becomes unable to spend valuable time with team members and understand what they ar

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

e feeling, or build credible relationships with them. These are vital to develop an awareness of issues that are arising in the workplace and to get to know individuals' d

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

ifficulties and aspirations, for future team development.

Secondly, employees begin to regard the manager as just another employee, at their level, and the discipl

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

ne afforded to someone in seniority fails, just when it is critical to have someone leading from the front. Respect is lost.

Thirdly, the lack of development provi

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

Following aspects would a

ded by a manager to each and every one of their people generates a boredom with the job. With little challenge, the job becomes repetitive. With little time for their employees,

dd to the challenges in developing combination products:

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

even praise becomes a rarity.

Finally, absenteeism and turnover increase. The hard working manager, doing their now 'day-job', is placed faces more tactical demand

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

s as he or she puts the 'doing' work in, to just keep up. As they have less and less capable people, inevitably, something falls off the cliff.

Typically the business starts to

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

nderperform and the manager gets put under pressure from above, often failing under the strain of self-imposed workload - but the wrong workload.

Challenging though it ma

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

y be, a manager has to step back from much of this 'doing' stuff in the workplace.

Short-term, things may get worse, but for the longer-term growth of the business, the manager

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

Professional from academic institutions, pharmaceutical industries, health care indust

has to manage their people effectively. Easy steps in this are spending time building relationships, defining robust standards, communicating effectively and managing perf

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

rmance.

Time spent here will be much more value-creating for a manager in developing their people and the business for which they are responsible, as well as providing 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

fulfilling role for them.

Manager or 'doer' - it is a choice and one which can take some time and effort to master. With it comes the maturity of realising where the futu

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

Companies that provide selfless information through particip

re lies - and what it looks like.

At the end of the day, as an alternative, stepping back from management and becoming a great 'doer', with the respect that brings is no failing

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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