Just Answers - Communications

A friend contacted me with a networking problem the other day that I thought I would share with you. Maybe you have experienced it as well. And you know the definition of experience right? Experience is what you get when you didn't get what you wanted!

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

My friend and his wife had gone wireless. They bought new laptops with built-in wireless (WIFI) and wanted to begin to roam around the homeplace untethered by LAN cables while connected to the Internet.

So in addition to the laptops they came home with

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

Examples of combination products may in

a LinkSys wireless router to provide the necessary access point for the laptops. The guy at the computer store said it would work like a charm. All they had to do was plug in the wireless router and go. After rebooting, powering off and on, and calling the comp

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

uter store all with no success, they figured they had nothing to lose by calling me. I haven't figured out whether I'm flattered or insulted.

Nonetheless, I was able to help because I had experience (see definition above).

Let's start with a

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

ittle background. As you probably know, to send and receive information on the Internet, your computer has to have an Internet Protocol (IP) address. This IP address is a part of the Internet's Transmission Control Protocol (TCP). These addresses, which uniquely

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

Combination pro

identify devices on the Internet, are given out in blocks to Internet Service Providers (ISPs) by the Internet Assigned Numbers Authority (IANA). Your ISP then redistributes these addresses to its customers. You, in other words! I haven't heard of any ISP that

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

gives out multiple IP addresses per account. Usually if you have one digital subscriber line (DSL) or one cable-TV Internet connection you get one IP address. And even then, the IP is frequently not permanently assigned to you. The ISP will let you use it while y

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

ou're online and then give it to someone else when you disconnect (i.e. turn off your DSL or cable modem). This process is called Dynamic Host Configuration Protocol (DHCP). Remember this DHCP. It will show up later!

So how is it that at your home you

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

ve been able to have more than one computer with only one IP address?

Well two things come into play. First the IANA has reserved the following three blocks of the IP address space for private internets:

 10.0.0.0    - 10.255.255.255  (10/8 pref

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

ix) 172.16.0.0 - 172.31.255.255 (172.16/12 prefix) 192.168.0.0 - 192.168.255.255 (192.168/16 prefix) Secondly there's another protocol called Network Address Translation (NAT) involved. The private IP address mentioned can be used freely and the Intern

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

et system should ignore any those addresses if they wander out on the information superhighway.

But your local router listens for those addresses. And if there are any packets, as they're sometimes called, with a private (or internal) IP address headed

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

Following aspects would a

out onto the Internet, your router will substitute its own IP address that it acquired from your ISP (this is the Network Address Translation). When information returns your router will get it first and keep track of where to send it back to you via your pri

dd to the challenges in developing combination products:

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

ate (or internal) IP address. Your router is able to do this even if you have multiple computers on your private (or internal) network.

Now, getting back to our problem. You may have noticed that your wired PC gets one of these NAT private addresses su

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

ch as 192.168.1.100 when you turn it on. Routers request a real address from your ISP (many times via DHCP). And then your router may give you an private IP address via its own DHCP server. When it gives you the IP address it also tells you to send your packets t

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

o it first. It becomes your gateway so that it can translate the internal private IP address to the real IP address. So the gateway IP address many (but not all) routers choose by default is 192.168.1.1 and especially LinkSys routers.

But here's what h

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

appened to my friend. They already had a wired router (a Netopia) that was getting a real Internet address and using a private internal gateway IP address of 192.168.1.1 for the computers on the wired network. When the new LinkSys wireless router was plugged into

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

Professional from academic institutions, pharmaceutical industries, health care indust

the Netopia, it asked for an IP address via DHCP. It was give an IP address of 192.168.1.114 by the Netopia. And then the LinkSys set itself up as gateway IP address 192.168.1.1 for the wireless PCs that connected. Now you might think this would work since there w

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

ere two separate private networks in fact. But as it turns out, routers are pretty smart, but apparently not that smart. The LinkSys wireless router received outbound packets at gateway IP address 192.168.1.1 but got mixed up trying to forward them onto the Netop

.

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

ia router which also had a gateway IP address of 192.168.1.1 that it was using.

The solution? Using the LinkSys browser-based configuration utility I changed the default gateway IP address to 192.168.2.1 for the LinkSys.

Now I ignored some I

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

Companies that provide selfless information through particip

P addressing issues such as subnets and masks. So if you're looking for more information or more details, try searching for "IP addressing", "private IP network", "NAT protocol", or "DHCP".

I hope my experience saves you from getting some experience

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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Design your web site so that it appeals to prospective patients and the search engines that bring them to you. Use your website as an extension of your waiting room to reflect your practice and differentiate from other practices on the Internet.

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