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A good service manager candidate for an automotive shop would really be the technician who knows a

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

lot about the motor vehicle but has been able to mentally switch gears and now learn how to sell the

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

Examples of combination products may in

knowledge he posses and the knowledge and services his team will provide. I am adamant about the kno

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

ledge part as I feel that the customer from the very first contact requires guidance right away whe

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

recommending service. Example being the other day I interviewed a person whom wanted to service ma

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

Combination pro

nage and he after a few questions seemed credible but revealed to me that on his own vehicle he requ

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

red an alignment for the shimmy that occurs at a particular speed. To the trained person this would

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

ow tell me that this person would book a car for the wrong service and this would start a chain reac

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

ion of a comedy of errors, possibly a technician would have to diagnose the service managers mistake

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

then the vehicles real problem, I will be willing to bet a lot of alignments are done.

A good mana

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

er would have a knowledge of what his team members were capable of and also what tools and equipment

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

Following aspects would a

the shop has to do the repairs. A good SM would also know time frames for jobs as to book properly a

dd to the challenges in developing combination products:

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

d also parts availability as to again book and inform customer of completion times. Sometimes the SM

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

has to participate with the tech for drive ability by actually driving with the customer until prob

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

em is verified and also asking the right questions to draw out clues to aid in the repair.

The SM m

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

st be a people reader as to only fill the bays with informed customers , getting the proper signatu

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

Professional from academic institutions, pharmaceutical industries, health care indust

es on the repair order as to sell diagnostics to only those whom have authorized them. believe this

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

is a tough spot because far too many techs love to just get into the testing and before you know it

.

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

problem almost found car all apart , time has flown by and no invoiceable hours accounted for. The S

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

Companies that provide selfless information through particip

must know time is to be guarded.

Thank you for reading I will continue my thoughts on next ezine

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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