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Outsourcing your software development can save you time and money if you know what you need. Too often US companies attempt to outsource without a good understanding of what their software should do, and this is the biggest cause of outso

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

urcing failure. It is unreasonable to expect your outsourcing team to have a menu of software, pre-prepared, so you can just select the items you want.

Ever go to a restaurant with a picky eater? They tell the waiter in excruciating deta

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

Examples of combination products may in

il how they want their food prepared. And heaven forbid that the food arrives different from what was requested! Back to the kitchen it goes to be "fixed" to make the picky eater happy.

Sometimes US companies hire an outsourced partner a

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

if they were going to a restaurant. They select the cuisine based on the flavor of the technology they require. Chinese .NET or Indian Java? How about some Russian C++? Unfortunately there is rarely a menu for the exact items you might l

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

ike to order from an outsourced team.

Are you approaching outsourcing your software like you are walking into a restaurant? Are you expecting the outsourcing team to advise you, like an attentive waiter, on the way your software should l

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

Combination pro

ook, be prepared and presented to your customers?

Instead, bring your own recipe when you start work with an outsourcing team. Unlike your dining experiences, you cannot ask for the daily special. You have to provide a specific descripti

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

n of what you would like to have, and how it should be prepared. Without such a recipe, your outsourced software development efforts can be starved for success.

Poorly specified software is often the result when "subject matter experts"

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

are involved. Subject matter experts, or SMEs, know a lot about a particular subject, like IC design, business process workflow, inventory management, etc., but very little about designing software. SMEs can struggle to get their ideas en

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

coded in the software. They need to work with someone that knows the best way to design and develop software.

Sometimes, there is a fear of getting bogged down in the details. Since some software executives are great with people, they fe

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

l much more comfortable hiring a person to handle the details. They know how to manage a person here, better than they can manage an offshore team of programmers in a remote offshore location.

One Accelerance client is in this situation.

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

The CEO wants to outsource the development of a new software product. But there is no specification. In this case Accelerance is acting as a virtual CTO, responsible for the design, and development of the client's software.

The client i

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

Following aspects would a

s essentially saying, "Design the software for me, and I'll tell you if it matches what I am thinking." This can work because the cost of outsourcing is so low that rework and multiple design iterations are affordable.

This type of arran

dd to the challenges in developing combination products:

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

ement only works when paying on a Time and Materials basis. There is no way to offer fixed pricing because the end product is not defined.

Of course, not having a specification may not stop you from asking for a fixed price bid! In this

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

case, you can outsource the creation of a specification that defines your software for a fixed price. Then the resulting complete design specification is used to create a second fixed price bid for writing your software.

Another factor c

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

omes into play when you pay a fixed price amount for a software design specification. You usually have to pay at least half up front. This is to protect the outsourcing company from delivering a specification for creating the software and

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

then not getting paid.

Because software design often occurs at the beginning of a relationship, both parties seek to minimize their risk. You minimize your risk by selecting an outsourcing team with a proven track record and great refere

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

Professional from academic institutions, pharmaceutical industries, health care indust

nces. The outsourcing team reduces their risk by getting partial (sometimes full) payment before starting.

There are multiple deliverables that should be produced during the design phase of creating your software, whether you do it yours

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

elf, or outsource the design:

* Marketing Requirements
* Storyboard Demo
* Functional Specification
* Multiple Release Milestone Schedule
* Detailed Task Schedule for First Release
* Detailed Design Specification

.

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

(optional)

Unfortunately, software development has not progressed to the point where ready-made modules are available to order and combined to create your software. There is not yet a menu of choices available to anyone that is hungry fo

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

Companies that provide selfless information through particip

r new software. Instead, you must provide your own recipe for what you need. The good news is low cost outsourced software design and development resources are now available to create your custom software to meet your exact specifications

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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Setting up your company with interchange plus pricing can save you thousands of dollars in fees when compared to a typical three tier rate structure. This is the same system used at major retailers - now you can benefit from this set up as well!

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