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Electronic Medical Record (EMR) and digital billing systems offer substantial clinical care, financial, practice workflow, and compliance benefits to doctors, insurance companies, and patients. But half of medical

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

practices that purchase EMR software fail to successfully implement it.

Rapid development is a salient feature of this technology market: eighteen news items published by technology vendors of electronic medical rec

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

Examples of combination products may in

rd and billing systems were listed in May 2006 alone on BillingWiki/Technology. The eighteen news items split seven-to-eleven between web-based Application Service Provider (ASP) solutions and Client Server (CS)-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 technologies. Upon briefly reviewing key factors defining each technology, we compare them along two criteria, namely implementation success likelihood and costs.

Client Server Architecture

CS model has

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

een around since the early eighties of the twentieth century. Its architecture includes a central server deployed at the doctor’s office and multiple client stations to allow the users to interact with the applicat

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

Combination pro

on. The central server typically runs the database and some of the application logic, while the client stations perform much of the processing locally.

Such distributed processing architecture facilitates relativel

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

y high application performance, minimizing waiting time. The downside of CS architecture is that it requires the practice owner to establish necessary infrastructure upfront and to continuously manage it down the ro

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

d. The infrastructure includes a central server, client terminals, and local network connecting the computers. The management tasks include installation, configuration, backups, restores, and periodic upgrades.

Th

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

refore, a typical CS charge model involves upfront investment in infrastructure and application license and subsequent monthly support costs as well as significant time spent on completing the required tasks and main

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

aining the knowledge level required for successful operation of hardware and software.

To justify an investment, CS solution vendors offer traditional five-year return on investment (ROI) analysis. Such analysis co

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

pares EMR benefits derived from reduced office workload, clerical and clinical errors, improved coding, and faster cash flow, to infrastructure ownership costs.

The pitfall of this approach is that it ignores both t

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

Following aspects would a

echnical and financial aspects of technology aging. Technically, Moore's law of digital technology development tells us that chip density doubles every 18 months. Therefore, computer hardware and technology develope

dd to the challenges in developing combination products:

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

on it becomes obsolete every 36 months. Can you justify an investment using five-year horizon in a technology, which might become outdated in three years?

Financially, investments make sense in goods that apprecia

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

e in value. Otherwise, renting business-necessary equipment or software often offers the double-pronged advantage of both freeing up cash flow and tax deductible business expense.

Application Service Provider A

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

chitecture

ASP model was introduced just before the turn of the new century. It is based on leveraging Internet. ASP architecture places the database server at the vendor’s site instead of the doctor’s office

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

nd allocates the majority of application logic to the server, reducing the amount of code needed to run the client. Such an approach allows the users to interact with the application directly via Internet browser, e

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

Professional from academic institutions, pharmaceutical industries, health care indust

ntirely eliminating the need for local office infrastructure and its management. The vendor manages all of the technology centrally and for all offices, including compliance, disaster recovery, installation, upgrade

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

, backups, and restores.

The ability to configure systems and train and support personnel without ever visiting the practice sites, provides one of the most cost-effective EMR solutions. Deployed remotely over the I

.

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

ternet, ASP methodology avoids time-intensive, on-site disruptions. Online training allows physicians and staff to schedule for convenience, further minimizing practice disruption.

Obviously, ASP model creates major

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

Companies that provide selfless information through particip

economies of scale eliminating the need for local IT staff. Typical charge model of modern Vericle-like solutions consists of monthly access fees and avoids investment in and ownership of associated infrastructure

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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