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When we started our first business some sixteen years ago, we thought we had the answer to everyone’s need for a great rehearsal studio. Rehearsal studios are soundproof rooms, which give bands a place to rehearse their music without disturbing the neighbour

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

s.

At the time we thought we’d done everything right. We had done business plans, projections, studied the market and found an area where there was a need. We found a building to lease that gave us an initial low rent while we did a fit out inside. We had 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

vered most bases, we thought.

But business always throws a curly one your way. Firstly, the building coordinator. Turned out he had more important jobs to do. We also found out later that his business was falling to pieces. In turn that delayed us. The buil

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

er. Agreed to a price, but could not deliver on time. We did get it finished, with a lot of hassle and extra money. Delayed again. The electrician. They were great. On time, on budget. The air-conditioning expert. Did not deliver. Ended up installing some ma

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

hines he had lying around that did not push out enough air. He also took about a month longer than he said to install, completely ignored our continued complaints, and then disappeared.

And there was the local council. We submitted a business application and

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

Combination pro

development application. What a nightmare. It took about four planning officers and two years to get final approval. We had to do deals with the landlord, because the building was so far behind in its council requirements. But we were trapped, we had star

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

ed building. Big mistake.

So, in effect we had been delayed by about three to four months. Now we were into normal rent. Ouch! No income.

The big day came and we opened the doors. Where were all the bands? Next day, no one. Next day, one band only. We were a

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

vertising in music magazines, distributing flyers at venues and music shops, running opening specials, where were they? Lesson one. Bands all talk to each other. That is the way they get the word about. In effect it took about eight months to create a decent

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

stream of income. We had fallen into the red very quickly.

Then there was the recording studio. This was built at the same time. One of our great fears was that noise from the adjoining rehearsal rooms would leak into the studio. To make sure we got it righ

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

, we hired an expert. He had built many studios in Sydney, big name studios. He went over the plans, made a few changes and OK’d it. He was wrong, we heard everything! We got another expert in. He said we should sue the previous one. More cost. We did not do

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

it. We spent more of our own time and money to fix the problem. It was cheaper.

Our working capital was insufficient to fund the extra time we’d taken to get the business up. This is a common fault, if not the most common for new business failure. It is bet

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

Following aspects would a

er to over compensate for working capital than under estimate. Have a big pool of money rather than a small one at your fingertips.

So here are some thoughts for you.

Your business budget should contain ample working capital. You may think you don’t need it.

dd to the challenges in developing combination products:

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

OK, you may not, but if you budget for it, it will be there if you need it. Remember this can be money that has been approved, but not drawn down. Therefore you don’t have to pay for it unless you use it.

If you have to fit out a space, add time to what you a

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

e told. I would double it. At least if it takes less, you will be ahead. Get a solid contract from all your tradesman. Fixed price, fixed time. It may not work out this way, but you will have a starting point to work from if it all goes sour. You could even

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

offer a cash bonus for getting the job done on time and budget. A few thousand dollars could be peanuts in comparison to what you will lose waiting for an extra month or two!

Get as many of your local council requirements out of the way before you build. R

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

member, these guys do not work on an hourly rate. They don’t really care that it’s costing you a bomb every time they open their mouths. Wait before you build. Believe me its worth it.

Depending on the market, you can get really good deals which will give lon

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

Professional from academic institutions, pharmaceutical industries, health care indust

rent free periods to help you build and get going. Otherwise you may be able to broker a deal whereby you pay less in the first year, then increase the rental from there. Of course, you must be certain of your business plan to sign to a lease.

And lastly

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

don’t expect your business to be filled with customers on the first day. Even if you can do that through good marketing, don’t expect it to happen every day initially. Plan for the scenario that it will be a gradual build. That is, have working capital on h

.

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

nd to help you through the first year.

So going back to our story. We did build the right rehearsal studio in the right place. The market needed us. We eventually had one of the busiest rehearsal studios in Sydney. But through all the mishaps, delays and cost

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

Companies that provide selfless information through particip

it ended up taking us a few years to get over the hump.

Those first days can be exciting as they are frustrating. But keep positive, work one problem at a time, double check the detail and don’t rush with your decisions. It will be worth it in the long run

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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Have you noticed that one of the aisles in your local supermarket or Wal-mart is now reserved for $1 items? Even though same item, under a different brand name, may be available for a higher price elsewhere in the same store?

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