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Main Subject - Use An MRD To Control Your Outsourcing
Is your software development process as unpredictable as the weather? Is your software casting a shadow causing six more weeks of programming? Are you using a marketing requirements document (MRD) or magic to predict your softw
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
are release schedule?
Early in my career, I worked in a lab for a company that sold microwave devices. I was responsible for the HP computer system that ran the software used to design the circuits. One day a tech support guy
Early in my career, I worked in a lab for a company that sold microwave devices. I was responsible for the HP computer system that ran the software used to design the circuits. One day a tech support guy
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
rom HP came by. He asked what we did in the lab. When I told him "designing microwave circuits", he said, "Oh, I hear they use a lot of FM".
I paused and tried to remember if Frequency Modulation was really used in these circu
I paused and tried to remember if Frequency Modulation was really used in these circu
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
its. Before I could respond, the guy from HP continued, "Yeah, it takes a lot of F-----g Magic to make those circuits work!"
He was right. A major issue with microwave circuits in those days was creating them with a high-yield
He was right. A major issue with microwave circuits in those days was creating them with a high-yield
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
manufacturing process. Too often there was much tuning and tweaking of individual devices with toothpicks and tweezers to make shipment dates.
Since then I have worked on a few software projects where some amount of "FM" was r
Since then I have worked on a few software projects where some amount of "FM" was r
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
equired to get the software released.
How about your software projects? Do they drift along never seeming to finish? Do they require the heroic efforts of a few individuals to make your shipment dates?
Outsourcing can solve t
How about your software projects? Do they drift along never seeming to finish? Do they require the heroic efforts of a few individuals to make your shipment dates?
Outsourcing can solve t
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
e issues of delayed software releases by imposing more process on your software development - more process than is typically used in an organization where everyone is working in close proximity.
Outsourcing vendors need to hav
Outsourcing vendors need to hav
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 a well-defined process and excellent communication to be successful. Software development is all that they do. Outsourcing not only gives you the benefit of having your software developed for less cost, but also a process tha
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
provides improved predictability, results and success.
But many remain fearful of outsourcing. The number one concern is losing control of the software development process.
One client expressed it this way. "I can't just tel
But many remain fearful of outsourcing. The number one concern is losing control of the software development process.
One client expressed it this way. "I can't just tel
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 the programmers what to do on a day-to-day basis. It would be like hiring a contractor to build a house and telling him to put a window over there and a door over here. You have to understand what impact that will have on the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
plumbing and electrical and the building of the rest of the house."
He is right. You need to have some idea of the architecture and the plan for construction. Working together with a few programmers in the same room can someti
He is right. You need to have some idea of the architecture and the plan for construction. Working together with a few programmers in the same room can someti
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
mes let you make some shortcuts and share the plan by informal word of mouth. “Just put a pop-up window over here.”
Except for small and simple projects, this informal communication does not work. You need some description of
Except for small and simple projects, this informal communication does not work. You need some description of
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
he requirements for the software. You need to find a way to efficiently communicate the requirements of your software so you can move beyond the "idea" stage with the vision for your software.
The first step in creating a soft
The first step in creating a soft
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ware product is to write a Marketing Requirements Document or MRD. It contains a brief description of all the features, functions and benefits your product must have to be successful in the marketplace.
Some companies make a d
Some companies make a d
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
stinction between an MRD and a PRD - a Product Requirements Document. The PRD has more details on what the software should do. For example, you need both an MRD and PRD when you are creating several services and products. The M
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
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
RD describes the product strategy, market positioning and sales channels required to deliver the products with specific sets of functionality to the market. The PRD on the other hand focuses on the detailed requirements of the
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
oftware itself.
The MRD or PRD should include basic architecture and the critical user interface for your software:
* Software architecture
* Hardware platform selection
* Functional specification
* User interface design
The MRD or PRD should include basic architecture and the critical user interface for your software:
* Software architecture
* Hardware platform selection
* Functional specification
* User interface design
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
*Multiple “use cases” describing how users will interact with your software
* Story board demo (optional)
* Major release milestone schedule
* Quality Assurance testing
* Technical Documentation requirements
* Detailed sch
* Story board demo (optional)
* Major release milestone schedule
* Quality Assurance testing
* Technical Documentation requirements
* Detailed sch
.
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
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
dule (up to completion of first major milestone)
* Cost estimate for cost-efficient and time-effective outsourcing development
Your marketing requirements document or MRD describes the functionality of your software product a
* Cost estimate for cost-efficient and time-effective outsourcing development
Your marketing requirements document or MRD describes the functionality of your software product a
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
nd how it will be sold and distributed. It is also a device to control your software development process, especially if you outsource. Otherwise you run the risk of delays, poor quality and just not knowing what you are doing
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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