Main Subject - Business

We have all had an experience where you get bad service or a bad product. Let me tell you about my recent experience, and we'll have a look at what we can learn from it.

My car had a problem. Broke down in fa

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

ct, so it was a large problem. The clutch was not working. I got the car to my mechanic. This guy has been my mechanic for about six years. I had followed him through each of his business moves. He knew my c

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

Examples of combination products may in

r well, had always done a good job and had very reasonable rates.

I could only say good things about this guy. I had no intention of changing my mechanic.

So back to the car. The car is a European brand. Goo

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

cars, but no longer sold in Australia. This can make getting parts difficult, but not impossible. My mechanic had had the car for two days. I had not heard from him, so I gave him a call. He told me it woul

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

be ready the following afternoon. That did not happen and it turned into the next afternoon. That did not happen and so it went over a weekend. Then nothing on the Monday. Each time, I had to ring him to fin

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

Combination pro

out what was going on.

He did not call me.

After nearly two weeks, the car was ready. When I went to pick it up I was a bit shocked by the bill. Nearly $2000. It turns out that to fix the clutch was going t

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

cost around $1000, but something else was wrong as well, so he decided to put in a new gearbox! I really would have liked to have known this. I was told that it needed a clutch kit only.

So anyway, I take t

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

he car home. A few days later, I notice an oil leak. It's quite bad, but it's now Christmas, so it will have to wait until the new year. Someone finally turns up in the second week of January. The young mecha

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

ic. He finds the leak (oil pressure switch) and changes the part. He's not there when I come to pick up the car. I eventually find the key stuffed up the exhaust and drive off. Twenty metres down the road, t

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

e oil light starts flashing and an alarm sounds! I pull over and check the oil. All seems OK, so I drive home.

We are due to leave for a holiday in two days so I forget about it. When I return I ring the mec

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

anic and tell him what has happened. It takes another week and a half to fix the problem. Then when it is ready, I turn up to take the car and find it on jacks! I ring in the morning, he apologises, but says

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

Following aspects would a

it will be ready that afternoon. It's on jacks again!!!

Now I am really mad. I write a terse note and shove it under the door. The next day I don not hear a thing! So I ring him. He does not seemed phased by

dd to the challenges in developing combination products:

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

what's happened at all. He says he'll deliver the car. I give him the address. Later that afternoon, he rings me because he's lost the address. I give it to him again. Finally he brings it home, but to the wr

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

ng house, five doors down the road. So, I have to talk to the neighbour about getting my key out of their letterbox! To his credit, he did not charge me for any of that work, but I expected that anyway.

Tha

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

t was four days ago. this morning while dropping off some paperwork. the gearbox fails on one of busiest roads in Sydney.

You can imagine my reaction...

Beyond all the mistakes he and his co-workers made, th

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

thing that annoys me more than anything is the lack of communication. If he had just told me what was going on, the experience would have been much better. You must talk to your customers.

We all make mist

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

Professional from academic institutions, pharmaceutical industries, health care indust

kes during our business life. We upset clients and make their lives a misery for a small amount of time. But, if you communicate with your client properly and educate them about process and time, you will hop

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

fully have your client at the end of it all.

Remember that if you lose a client because of not handling a situation properly, it will cost you dearly. Repeat business is your life blood. It is gold. It costs

.

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

so much to attract new customers and make them comfortable to stay.

The car saga continues and about a week after all the gearbox problems seem fixed, it breaks down again. This time, nothing related to the

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

Companies that provide selfless information through particip

echanics work. To his credit and his instinct that things have not been great, he does the job for free and it was not an easy one. This has reassured me of him. Maybe I'll be a customer for another six years

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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