Main Subject - Internet and Businesses Online

Much has been written over the years about the possibility of creating a second Internet. It was the hottest topic on many editorial calendars early in 2007 until it faded into obscurity. The concept was, after all, not new to anyone in the information industry over the last ten years. Vice President Gore actually proposed the creation of a second Internet aimed solely at providing the vehicle for a national h

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

ealthcare infrastructure, designed to support the implementation of a national patient ID program and for use in the cataloguing of Electronic Medical Records. The hope was to tie all healthcare facilities together so that at any point of care, the patient ID would give the caregiver a unified view of a patient’s medical history no matter where they had been – a virtual computerized patient medical history.

W

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

Examples of combination products may in

hy did this not come to fruition? Several death knolls were sounded but perhaps the most damaging argument, not including the mounds of cash necessary to make it happen, was the fear that a person’s medical history would not be secure and that the information contained therein would be used against them. An example of this type of misuse lies in the potential for an employer to reject a potential employee bas

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

d upon a medical “blip” or condition.

Fast forward to the winter of 2006…

The driving factor for a second Internet is no longer healthcare but security and the inability of anyone to make a considerable dent in the growing problem of hacker exploits, intrusion and theft. The number, gravity and differing approaches of these attacks are creating a basis of consumer and corporate fear. A well founded fear, th

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

at at any given moment, any company or any individual may become the victim of a devastating security event – an event that could threaten their very livelihood. To further complicate matters, adding to the security “fear factor”, post 911 and homeland security worries have further confounded the experts. The cyberwar that was predicted for years has unfortunately arrived. It takes no more than five minutes

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

Combination pro

f data mining on the Internet to find countless examples of public and private entities that have been “hit” by new cyber-criminals. These events have become so common place that many go unreported as they are no longer considered “newsworthy”.

Regardless of current best practices and policies, Chief Security Officers and Information Assurance Executives across the globe still lie awake at night praying they

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

are not the next victim driving the call for a more secure, well-behaved Internet. A world of bits, bytes, and nibbles where every light pulse and square wave is accounted for, where every hacker can expect a long stay in a small concrete cell, and where spam is truly a meat substitute.

The Internet2 Villain

Surprised? Believe it or not, the technical creation of a second Internet is a “slam dunk”. There 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

e no plausible reasons why a new Internet could not be created, with relative ease from currently available technologies. The ability to create an IP based network on which every attached device and user is identifiable and accountable is child’s play. Granted, it would take time and money to launch such an effort but for probably half the cost of the Iraq war even a project of this scope could be well underw

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

ay. As a matter of fact, the project itself would probably create enormous opportunity in jobs and advances in technology. Money, time, technology, and manpower are plentiful. The real problem lies elsewhere.

To illustrate the point, consider the following. For the sake of argument, let’s break out the preverbal time machine and let the idea of a second Internet run its course. Fast forward to the point w

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

ere the technological design is complete and assume it is sound and supported. It is at this juncture where things start to get messy. In a small conference room, a team is huddled around the design specifications as they go about the process of writing a bill of materials with its corresponding RFPs to procure the best and most cost effective components to be used in building the new Internet. Can’t you jus

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

t feel the impending doom?

Again, fast forward ahead several weeks. The RFP’s are complete and ready for release. Thunder booms in the distance and a shadow creeps over the process. The first problem rears its ugly head to slap the team back into reality. Who are they going to send the RFPs to? Which vendors will be chosen to receive them or not? What are the criteria for vendor selection? Who has the p

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

Following aspects would a

ower or the right to deny any company the opportunity to bid? All of a sudden the fast moving train faces derailment.

Capitalism, the villain, laughs heartily. The biggest obstacle in the creation of a second Internet is not the technology but the ability to get through the RFP process and into implementation without creating a stack of litigation paperwork that would rival the landfills of New Jersey. The

dd to the challenges in developing combination products:

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

problem is twofold: in the first place, who gets to bid on the various components and secondly, who will select the winners? Every person appointed to the selection committee will potentially find themselves the target of numerous accusations and criticisms designed to discredit them and to ultimately coerce the outcome. The legal and media circus will make presidential elections look like papal proceedings.

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

There is simply no viable way to create the necessarily impartial body of experts to evaluate all of the RFP bids and to make selections without being challenged so many times that the project itself would grind to a stand still. Even if the right vendors were to be selected, the only winners would unfortunately be litigation lawyers. Unlike trials that are relocated to avoid contamination by local fervor, th

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

re is no location that can claim complete impartiality in this case. The RFP release and award process would simply die on the vine.

But all is not lost….

Internet2 – the Hero

A wise man once said, “He who proposes, disposes.” I hate letting down wise men.

The answer to this conundrum of capitalism actually lies in the problem itself. While it is undeniable that the creation of a second Internet led by a

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

ny well intended and impartial group of experts is doomed to suffer a slow and painful death, the opportunity clearly exists for one of the current captains of the Internet industry to step forward and take advantage of this potentially profitable opportunity. The best chance for the creation of a second, more secure Internet rests with either one of the current national ISPs or with a new, well funded, upstar

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Any corporate development officer or entrepreneur could sit down in their nearest coffee shop and put together a compelling pitch deck over one cup of cappuccino as the same fear that drives the need for a new Internet is the perfect driving factor for offering the public a new solution. If a leading ISP were to invest in the technology required to make a new secure Internet, they could, without contest, of

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

fer this environment to any company or customer. Most customers would gladly pay double just for the comfort of knowing their e-commerce was secure.

What would be impossible for the government or IETF to accomplish would be a “done deal” for any of the industry’s uber-ISPs. The only holdup is the time it takes for them to either reach their moment of fiscal enlightenment or to read through this dissertation!

.

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

If Comcast called your business tomorrow and offered you a secure Internet or your money back, would you jump? Perhaps not after the first call, but in all probability the second cold call would close you. What if you could remove the twelve layers of anti-malware hardware and software you presently pay millions of dollars a year to maintain, would you then? I am certain that, over time, most if not every

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

Companies that provide selfless information through particip

company would become faithful customers.

Fin

Here is the part where the disclaimer lives. There will no doubt be countless individuals who will take issue with the premise of this prose but if asked to bet on who has a better chance of creating Internet2, some impartial body or one of the present players, only those who live to be obstinate would wager against the latter.

Pardon me while I go call my bookie

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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Splitting a branding project typically results in a lack of consistency between pieces in your marketing kit. All of your brand materials should have similar design elements. When a project is split among different design firms, often those firms don't have a similar style, and you can wind up with print collateral, for example, that looks dramatically different from your website.

You may have great experience, exceptional qualifications, and all the skills and abilities in the world, but, take it from a leading HR psychologist, you could blow your chances for a great new job if you don’t get the interview right.

Can a work at home online change your life? I have a personal preference to think this question by a financial vision. See it here.

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