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How important are staff to your business? That’s sort of a basic question, because everyone knows that without staff you can’t do your own job. But really, how important do we consider our

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

staff? After all, they haven’t been to school as long as we have, they don’t know as much, they don’t make the money we do. Shouldn’t it be easy to replace them when we need to?

It’s easy t

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

Examples of combination products may in

fall into the trap of under-rating the importance of staff to a business; but it’s at least as bad to have the wrong staff in your organization. Who are the ‘wrong’ staff? Most of us would

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

say those who don’t work hard, or take too many breaks, or don’t know what they’re doing, or who don’t take initiative. Now, these are serious defects, but the problem goes deeper – are we

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

eeking staff who really complement the business?

When you opened your business you had an ideal in mind. Most likely it included finding and pleasing customers, providing a high quality pro

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

Combination pro

uct, delivering top-notch service to support your product, and getting customers excited enough to tell others about you. Business owners have values they bring to their business. The probl

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

em is, most don’t take the time at the front end to formalize those values, and they almost never seek to hire staff who share those same values.

So what happens? The staff who are hired do

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

’t match the ideal the owner had in mind. They might be too brusque, or even unfriendly with customers. They might not get along with other staff, and become a constant source of irritation

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

. They might get flustered when the business gets busy, frustrating both customers and other staff. Maybe they just don’t have the drive that you were wanting in your staff.

But really, ca

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

you do anything about that? Sure you can; and the answer comes in two parts: First, taking the time to identify and formalize your own values, and then build them into the business. Wha

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

attitudes do you really want in your business? Do you want customers to feel fussed over, or are you happier with more of a formal professionalism? Do you want staff who take initiative, o

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

Following aspects would a

r would you rather have people who check in before making major decisions? Are you concerned with neatness and order, or do you like an atmosphere that’s more laid back and friendly? When ch

dd to the challenges in developing combination products:

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

osing any of these approaches, you will need to plan your office structures so the attitude can happen. Failure to plan such a structure may make it difficult – or impossible – for your sta

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

ff to act the way you want.

Second: For hiring people, translating those values into behavioral interviews is key. If you want certain attitudes and behaviors, you have to build an intervi

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

w that goes beyond the resume and surfaces underlying conduct. People, especially those who can’t hold jobs for long, can be very good at ‘saying the right thing’ – even when they don’t usua

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

ly act that way. Part of your challenge is developing questions that will dig out those past behaviors. The questions might be aimed at finding out the prospect’s reaction to a busy environ

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

Professional from academic institutions, pharmaceutical industries, health care indust

ment, or how they usually handle a customer. Questions can be worded to surface bad attitudes under stress, or a prospective employees work ethic.

Believe it or not, the bulk of a business

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

wner’s time and money are spent hiring people with the right knowledge and skills – but the majority of problems and firings are based on attitudes and behaviors.

CONCLUSION:

In summary, if

.

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

you want your business to move closer to your mind’s ideal, you have to take time to identify and formalize your values, building them into the structure of your business – how it is run. T

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

Companies that provide selfless information through particip

EN you have to develop an interview process that surfaces a prospective employee’s behaviors, and checks them against the attitudes you are seeking in the day-to-day operation of the 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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