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How important are staff to your practice? That’s sort of a basic question, because everyone knows that without staff you can’t do your own job. But real

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

ly, how important do we consider our 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

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

Examples of combination products may in

we do. Shouldn’t it be easy to replace them when we need to?

It’s easy to fall into the trap of under-rating the importance of staff to a practice; but i

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

t’s at least as bad to have the wrong staff in your practice. Who are the ‘wrong’ staff? Most of us would say those who don’t work hard, or take too man

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

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 hiring staf

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

Combination pro

who really complement the practice?

When you opened your practice you had an ideal in mind. Most likely it included doing the right thing with patients

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

, providing top-notch care, having patients excited enough to tell others about what you were doing. Physicians have values they bring to their practice.

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

The problem is, they 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

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

.

So what happens? The staff who are hired don’t match the ideal the doc had in mind. They might be too brusque, or even unfriendly with patients. The

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

might not get along with other staff, and become a constant source of irritation. They might get flustered when the practice gets busy, frustrating both

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

patients and other staff. Maybe they just don’t match the level of neatness you wanted in staff dress.

But really, can you do anything about that? Sure

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

Following aspects would a

you can. The answer has two parts: First, taking the time to identify and formalize your own values. What do you really want in your practice? Do you

dd to the challenges in developing combination products:

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

ant patients to feel fussed over, or are you happier with more of a formal professionalism? If so, you will need to plan your office structure so that c

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

an happen. Would you trade some level of income for more time with your family? If so, you have to structure things for the practice to “run itself” to

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

certain extent AND find the people to do that. Second: For hiring people, translating those values into behavioral interviews is key. You have to buil

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

an interview that goes beyond the resume and surfaces underlying behaviors. Do you want staff who are neat and precise, or are you looking for those who

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

Professional from academic institutions, pharmaceutical industries, health care indust

are more laid back? How about colleagues – are you more concerned with the academic accomplishments of your fellow physicians, or would you trade that

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

for someone who works hard and pulls his weight? Believe it or not, the bulk of time and money are spent hiring people with the right knowledge and skill

.

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

s – but the bulk of problems and firings are based on attitudes and behaviors.

CONCLUSION In summary, if you want your practice to move closer to your m

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

Companies that provide selfless information through particip

nd’s ideal, you have to take time to identify and formalize your values, AND you have to develop an interview process that surfaces a prospect’s behaviors

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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