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A customer calls for help on her Blackberry Device…
Me: Hit Escape twice
Customer: Do you mean on my computer?
Me: No, I’m sorry, I meant on your Blackberry.
Customer: I do not see the ‘escape key’ on my Blackberry.
Me: It’s the button below the trackwheel.
Customer:

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

You mean the thing I roll?
Me: Precisely!
Customer: (excited) Oh my goodness, I see the number by the envelope getting bigger, it’s going bananas! I see all my messages coming in now. Thank You So Much! You are a patient woman.
Me: You’re most welcome and no worries, it’s my job!

A

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

Examples of combination products may in

lthough I thought the situation was slightly comical at first that my customer would think to hit the escape button on her computer instead of her Blackberry, it dawned on me that her rationalization might not have been very far off. With her Blackberry tethered to her computer via her USB sync cabl

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

e and no true expertise on the wireless or technology world, those two devices are seemingly more closely related than we think. Both instruments can receive email independent of each other. They both have QWERTY style key boards that function similar ways and the program icons are on the home scre

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

n. You can access your Outlook contacts, calendar and tasks from both devices. They are both generally sold by salespersons that aren’t very knowledgeable on product specifics and they sell them like they are selling a piece of furniture. Out of the box it seems that both are as simple to set up as

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

Combination pro

plugging them up and start using them. However, it generally turns out that neither device is very intuitive to set up and most Blackberry’s do not even come packaged with a user manual, so it is not like you can read the instructions even if you wanted to. A call into customer care (dependent on 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

he wireless provider) for assistance with set up and configuration help usually means an hour on the phone walking through a lot of steps that is full of technical jargon and terminology that the layperson often does not understand. While hitting CTRL + ALT + DEL “reboots” a frozen computer, a “hard

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

reset”, removing the battery and hold power button down for 60 seconds does the equivalent on a Blackberry. And who can live without either device?!?!?

The first decade of the personal computer was full of people buying individual machines, while the second decade of the personal computer was devot

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

ed to people connecting them. Now you cannot go anywhere and find a computer that is not connected to a network. With the introduction of the digital phone in the U.S. in 1994, the first decade of wireless had been consumers purchasing individual digital phones. The next decade will be people netwo

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

rking digital phones. This is becoming more evident with the introduction and emergence of the Blackberry and other wireless Personal Digital Assistants (PDA’s) along with new technologies like Bluetooth & Wi-Fi enabled in the devices. Although it sometimes seems like ‘everybody has one’, wireless

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

DA’s current penetration is actually less than 3% of the cellular market share, according to Research Firm Strategis Group. Over the next 3 years the wireless PDA market share will grow to 20% and by 2015, like every computer, every wireless handheld device will be connected to a network other than t

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

Following aspects would a

raditional cellular network somewhere.

As this transition begins to take place, IT helpdesks that are currently managing terrestrial networks within organizations and government agencies are being given the task of managing wireless resources by default. They are coming to the realization that the

dd to the challenges in developing combination products:

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

wireless industry is a much different animal than the IT world they are used to. Wireless IT requires a completely different level of support and has its own set of terminology. The Blackberry or wireless PDA is not like a $600 computer workstation sitting on a desk. It is a device that costs that

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

amount and more over the course of a year.

As senior level management reads about the great applications and services that are available on the wireless handheld, not enough of the end users are actually taking advantage of these services and features meaning that their ROI (Return on Investment) i

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

ZERO. Due to lack of or non existent training, often end users have a difficult enough time just understanding how to program phone numbers and check their voice mail, traditional old school cellular tasks. The IT Helpdesk generally cannot help solve problems beyond the basics without a call into

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

customer care themselves. This in part comes from the disconnect that while computers and handheld wireless devices are parallel today in many respects, wireless devices unlike computers are constantly in motion and communicating within multiple networks; the cellular network, the carrier data netwo

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

Professional from academic institutions, pharmaceutical industries, health care indust

rk, the corporate network and the Internet and therefore requires intense resource and physical management to make it do what you want it to do and take full advantage of what the device has to offer.

Support levels need to be provided at the manufacturer and carrier level. At this time of tremendo

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

s industry growth, both have a hard time adequately staffing their customer care departments. This is where effective independent sales organizations can pick up the slack. Sales personnel who are properly trained on the capabilities of the devices they are selling can be an invaluable source of su

.

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

pport to the customer and IT Departments struggling to adapt to the new challenges of dealing with a new technology. The current disconnect is in the customer’s willingness and to pay for the extra support or paying indirectly by having their $80,000/year IT staff on the phone for three hours with c

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

Companies that provide selfless information through particip

arriers and manufacturers trying to resolve a simple issue with a wireless device. And just how ironic is that? Presumably no different than thinking that a Blackberry and a computer are as vastly the same as they are different. Handheld is powering off, press any key to abort. ….Now shutting down

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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