Main Subject - Business

I recently stayed at a major hotel in Perth, Australia. On the telephone in my room was a small card indicating the phone and fax numbers of the hotel.

The

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

phone number was listed as (09)225-1234.

Clients around the world intended to call me during my stay, so I gave them the hotel number.

Not a single person

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

Examples of combination products may in

as able to reach me by phone. One sent e-mail complaining I had given him a wrong number.

I called the hotel operator to check the telephone number and told

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

her about the small card in my room.

‘Oh,’ she replied, ‘the local code is not (09) anymore, now it’s (08).’

‘When did that change?’ I asked.

‘About four

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

years ago,’ she replied, ‘but everyone knows about it.’

I quickly contacted my clients overseas, and gave them the new number to reach me (08)225-1234.

Aga

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

Combination pro

n, not a single person was able to reach me by phone! I received another wave of ‘wrong number’ complaints.

I called the hotel operator a second time, again

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

reading her the phone number on the card in my room, but changing (09) to (08).

‘Oh,’ she replied again, ‘the code is (08), but now you also have to keep 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

e 9 as part of the main phone number.’

‘So the correct number is actually (08)9225-1234,’ I confirmed. ‘When did that change?’

‘About four years ago,’ she

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

eplied, ‘but everyone knows about it.’

Absurd, isn’t it? This hotel has 367 rooms, and very few people staying overnight in those rooms come from Perth.

I

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

wonder how many guests have experienced the same problem over the past four years? I wonder how many staff from Housekeeping and Rooms Division see, clean, s

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

raighten and even replenish those inaccurate little notecards every day?

I spoke with the Business Manager, Michelle. She thanked me for my feedback and pro

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

Following aspects would a

ised to do something about it right away.

I asked her to post a $100 credit to my room account, not to compensate for my frustration, but to ensure the hote

dd to the challenges in developing combination products:

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

l took this matter seriously and would get the issue resolved. She agreed immediately and promised to make the adjustment on my bill.

The next morning when

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

checked out of the hotel, no credit posted to my account. How predictably inefficient.

I wonder if it will be four more years before the small cards in the

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

rooms are changed? I wonder how many more guests will suffer with wrong telephone numbers posted in their rooms? I wonder how many times the hotel operator w

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

ill say ‘But everyone knows about it.

Key Learning Point
--------------------------------------------------------------------------------
Over ti

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

Professional from academic institutions, pharmaceutical industries, health care indust

e, many facts do change including phone numbers, features, stocking codes, availability, prices, procedures, packages, prerequisites and more. If you don't k

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

ep them up to date, your customers will find the errors, and feel the pain.

Action Steps
-------------------------------------------------------------

.

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

-------------------
Check your data now. Be sure every piece of public information about your company, products and services is accurate and up to date.

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

Companies that provide selfless information through particip

When customers look, listen, read, research, surf, shop or ask questions, be sure the information they receive is current and complete, not old or obsolete

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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We all make mistakes in business. The important issue is that we learn from them and apply the lessons in both our online and off-line business activities.

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