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One workshop participant asked this question:

I’m designing a performance measurement system for our in-house technology team and have run int

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

o a disagreement with my boss.

He would grade a support technician as ‘A’ if the Service Level Agreement (SLA) norms have been met, and ‘A+’ for any additiona

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

Examples of combination products may in

l enthusiasm shown.

I want to give only 50% for meeting the SLA norms since these are non-negotiable specifications. The remaining 50% I would give for enthus

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

iasm, special assistance and ongoing development of the expert. What do you think?

Here is my reply:

You need to clarify wi

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

h your boss and the rest of the in-house team what an ‘A’ should actually stand for.

In most schools, ‘C’ is ‘satisfactory’ – which means all the ‘non-negotia

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

Combination pro

ble’ specifications have been met. I also refer to this as ‘customer satisfaction’.

‘B’ is ‘good’ (B+ is very good) – which means all specifications are met a

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

nd the work is done with some notable level of enthusiasm, individual initiative, etc. This is the domain of ‘customer delight’.

‘A’ is for ‘outstanding’ – wh

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

ch is reserved for performance well above and beyond the call of duty. ‘A’ is for extra-mile effort that brings the customer, or the company, to a new level of

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

performance.

‘A+’ is legendary, a breakthrough, a brand new benchmark for others to remember, admire and follow. This is where your customers become ambassad

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

ors, enthusiasts, fanatics and devotees.

To my mind, an ‘A’ should not be given for simply ‘doing the job’. ‘Doing the job’ is just expected, merely satisfact

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

ry. That’s a ‘C’.

Doing more than the minimum job is where higher grades should be awarded.

I recommend you bring together your in-house customers and the me

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

Following aspects would a

mbers of your technology support team. Encourage discussion. Let there be a healthy debate.

Ultimately, agree on what A, B, C, D and F will stand for in your

dd to the challenges in developing combination products:

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

unique context. Then grade accordingly.

Key Learning Point

Within an organization, departments may have very different opinions about how w

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

ell they are doing, and how well, or poorly, other departments around them are performing. These disagreements stem from a lack of clear standards for evaluati

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

g internal service. This can lead to misunderstanding, inter-departmental tension and low motivation and morale.

Setting clear standards provides a platform f

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

or better communication. Raising standards over time is a pathway to continuous improvement.

Action Steps

If your department supports, relies upon or works c

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

Professional from academic institutions, pharmaceutical industries, health care indust

losely with another department, call a meeting to review or create agreed service and performance standards.

Use these questions to get the conversation rolli

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

g: How do you know when you are doing a good job? How do you know when other departments are doing a good job? What do you consider ‘satisfactory’ inter-depart

.

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

mental performance? What constitutes ‘above average’? What could another department do that would delight you, astound you or have you stand up and applaud?

T

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

Companies that provide selfless information through particip

his commitment to setting clear standards is useful for internal support situations. You can – and should – use this approach with your external customers, too

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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