Main Subject - Business

Interoperability is one of the sacred goals of IT, and even consumer computing. If operating systems, utilities, and applications do not work together, user productivity matches the low

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

level I achieve on Friday around cocktail hour ... which is "none at all."

Open Source is ripping profitability out of the IT software market in part do to growing interoperability. U

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

Examples of combination products may in

nlike traditional technology vendors, Open Source benefits from creating the greatest amount of interoperability possible. More commercial vendors keep margins high by locking in custom

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

rs to their suite of products. This is partially achieved by minimizing interoperability with competing and non-partner solutions, and thus raising switching costs should a customer con

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

sider "dumping and jumping" to a different stack.

Linux/GNU and their compatriots have been a model for interoperability. They collectively seek to create as much of the stuff as possi

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

Combination pro

le, assuring most of the components of the Linux stack work extremely well together. Without traditional profit motives, the only barriers to interoperability were time and complexity (

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

the time it takes to code interoperations, and the complexity of supporting multiple points of interoperation).

But this interoperability has been done on a handshake when developers fr

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

om different projects found need and motivation. This has led to odd partnerships, some necessary exclusivity, and a bit of weariness by IT in adopting Open Source solutions for fear th

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

t necessary interoperability that exists today might not exist in the future. Open Source has now grown to a point where consumers desire a bit more structure.

The Open Solutions Allia

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

nce (OSA) has started adding structure. This happened pretty quickly for an organization that didn't exist three months ago. But when you have founding members like CollabNet (who now

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

wns SourceForge Enterprise), EnterpriseDB, Hyperic, JasperSoft, SourceForge.net, SpikeSource, and Unisys ... well, you have a bit of muscle to get things done.

What OSA initiated is an

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

Following aspects would a

interoperability roadmap -- an attempt to specify some well-defined interoperability standards in the business software space. That's right, interop in applications. The objective is t

dd to the challenges in developing combination products:

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

o document standards and best practices for Open Source developers to use when building their software. The OSA will help by prototyping working code to demonstrate the principles of th

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

standards. The initial prototype will be the Common Customer View. This standard joins information held in different applications (CRM, ERP, etc.), business intelligence software, and

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

for demo sake, a legacy point-of-sale application.

This presents new issues for software marketing professionals. If you are a traditional application vendor, you will eventually enco

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

nter new competitive threats. All other things being equal, interoperability between Open Source applications would be a deal-making differentiator. Your products will either have to i

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

Professional from academic institutions, pharmaceutical industries, health care indust

nteroperate with best-of-breed commercial applications, interoperate with Open Source applications using OSA standards, or both.

If you are a dual-source vendor, these standards will be

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

come part of your value proposition. This is a boon to dual-source vendors, creating an advantage over best-of-breed commercial applications while adhering to the Open Source promise of

.

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

lower cost and greater flexibility. I can foresee a time when the old networking-centric Interop trade show could become the application-centric Interop event, where all the application

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

Companies that provide selfless information through particip

software vendors demonstrate live how they work with all the other vendors in the building. Interop launched standards-based networking, and OSA may launch standards-based applications

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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