Advice You - Business

Come on, don’t deny it; we’ve all said that at one time or another (yes, under your breath still counts). We know that our job is to get things done – not to do them ourselves. So

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

why do we often end up frustrated when we think something hasn’t been done properly?

The easy answer is that we have employees who don’t have the initiative, skills or experience to d

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

Examples of combination products may in

anything except follow instructions. (OK when we’re starting out, not when we’re growing quickly.) But - what about the ones who are giving the instructions (that would be us)? How w

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

ll do we hold up our end of the deal?

Things don’t get off to a good start if we only delegate when we’re overwhelmed and missing deadlines. We’re probably not communicating effec

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

ively then! Bear in mind that if you give someone something to do and they’re not sure what you mean, the chances are that they may not ask questions. (Who wants to look stupid in front

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

Combination pro

f the boss?)

On the other hand telling someone how to do the job in minute detail (the most common mistake we make) is equally unproductive. They’re going to check every step and

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

very decision with us, making for constant interruptions in the work we had to get done in the first place! Added to which they’ll think we’re treating them like an idiot and won’t volunt

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

er their ideas – which may, just may, have been better than ours anyway!

It’s our job to tell the employee what has to be done and when it has to be completed. (Make the deadline

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

lear, up front, and avoid the temptation to change it.) But it’s theirs to decide how to do it. After delegating a job, try asking whoever will be doing it to tell you (in an email or a n

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

te) what they think has to be done, the result you want and when you want it completed.

If it’s a job that will take all day have them give you feedback at coffee break, then at l

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

nch time. If it’s going to take a week, support them often in the first couple of days, but remember to back off when you see it’s going well.

If it’s a longer term thing start with a

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

Following aspects would a

timeline or project plan. Help whoever is responsible to complete it but don’t do it for them (if they can’t finish the timeline that may be a clue about the outcome of the project).

dd to the challenges in developing combination products:

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

Make it clear which decisions they can make on their own – and which they can’t. Put it in writing so they can refer to it when they’re unsure. Stay in touch often until they – and you –

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

ain confidence, then back off. Be prepared for mistakes and ask the people involved why they think things went wrong – don’t tell them.

Sometimes, when the business is under pressure<

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

b> for one reason or another, we ask employees who are competent or knowledgeable in one area of the business (for example collecting receivables) to do something for us in another area (

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

ay purchasing). So we skimp on the details of what has to be done and what we expect and leave them to figure it out – after all they’re good at what they’ve been doing, right? Wrong. Ask

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng someone to take control/responsibility for a key function or area without making sure they fully understand what’s required is like putting a teenager in the driver’s seat of a car for

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

the first time and saying drive – on the 401. In effect we are abdicating not delegating.

When you hire or promote supervisors remember that the people you consider must have more

.

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

than just knowledge and experience of the area they’ll be responsible for - they must be able to delegate and manage other people too. So look for those qualities in the candidates for th

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

Companies that provide selfless information through particip

job. Visit Jim's web site http://profitpath.ca/ for more information.

© Copyright ProfitPATH, a division of JDS & Associates Inc., 200

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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Advice You - Why Aren't Things Done Properly – Unless I Do Them Myself…?

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