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Digg It - Must Project Managers Be Technically Savvy?
“Must Project Managers be technically savvy?” This topic always seems to cause quite a stir. While some believe that all you need to manage a project is a PMP certification, others are convinced that you can't succ
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
essfully manage a software development project unless you truly understand the intricacies of the product.
I agree! To be an effective Project Manager, you must know the ins and outs of your solution. You must be
I agree! To be an effective Project Manager, you must know the ins and outs of your solution. You must be
; 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
capable of designing and developing the solution yourself.
Here are 5 fundamental project management tasks that Project Managers can't accomplish unless they have a strong technical background and truly understand
Here are 5 fundamental project management tasks that Project Managers can't accomplish unless they have a strong technical background and truly understand
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the particulars of their product.
Estimating Effort
In order to create a project plan, you must be able to estimate how much effort is required to complete all of the required tasks. Needless to
Estimating Effort
In order to create a project plan, you must be able to estimate how much effort is required to complete all of the required tasks. Needless to
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
say, you can't estimate effort unless you truly understand what's involved in designing and implementing those features.
Unless you understand what's required to reach 5-9 reliability, you can't assess how much ef
Unless you understand what's required to reach 5-9 reliability, you can't assess how much ef
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
fort is required to achieve this non-functional requirement. Unless you clearly understand how to write Java Server Pages, you can't predict how much development effort is required to transform an HTML prototype to
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
set of fully functional JSP pages.
Scheduling Tasks
Imagine that someone hands you a list of activities that need to be completed for a given project, along with the overall effort. Could you sc
Scheduling Tasks
Imagine that someone hands you a list of activities that need to be completed for a given project, along with the overall effort. Could you sc
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
edule the tasks in a logical sequence? Should the developers start with the presentation, the business, or the data storage layer? Which comes first when working on a presentation layer: the HTML, the JavaScript, t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
he CSS, or the servlets?
A Project Manager must be able to schedule activities in a logical sequence. If you can't determine which activities must come first and which ones can be done in parallel, you can't put t
A Project Manager must be able to schedule activities in a logical sequence. If you can't determine which activities must come first and which ones can be done in parallel, you can't put t
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
ogether a project schedule.
Assessing Risk
Imagine the following scenario. Your product is scheduled to be released in 5 days. The QA team discovers a defect in the API through a series of CLI te
Assessing Risk
Imagine the following scenario. Your product is scheduled to be released in 5 days. The QA team discovers a defect in the API through a series of CLI te
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ts. After carefully examining the problem, you realize that you're developers have been working around this defect for months.
Given that you're only 5 days away from releasing your product, should you fix this de
Given that you're only 5 days away from releasing your product, should you fix this de
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
fect or document the workaround? At this point in time, how risky is it to modify an API that's being used? How confident are you that the developer can fix this API in the given timeframe? What's the likelihood th
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
at changing this API will break the modules calling it? Should you fix the defect now, or release the product and address the bug in a patch release?
Unless you've seen the code behind this interface, you can't an
Unless you've seen the code behind this interface, you can't an
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
swer any of these questions yourself. You need to ask your developers. You're not the decision maker. They are.
Participating In Customer Meetings
Customer meetings always end up in technical dis
Participating In Customer Meetings
Customer meetings always end up in technical dis
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
ussions. Unfortunately, if you can't speak intelligently about your technology, you can't add any value to such meetings. You're not participating; you're strictly listening, and perhaps taking notes. Sooner or lat
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
er, your customers will find themselves contacting your developers directly. “Why contact the Project Manager if he can't give me an answer? I may as well go straight to the source.”
Ensuring Nothing Falls
Ensuring Nothing Falls
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
Through The Cracks
Let's face it. You never get as much time as you'd like to plan your projects. What's important is not that you get it perfect the first time around. What's important is that you can c
Let's face it. You never get as much time as you'd like to plan your projects. What's important is not that you get it perfect the first time around. What's important is that you can c
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tch the tasks that fell through the cracks before it's too late.
If you don't know what's required to complete your solution, you won't be able to identify all the overlooked activities. They'll either be pointed
If you don't know what's required to complete your solution, you won't be able to identify all the overlooked activities. They'll either be pointed
.
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
out by your developers, or simply omitted forever.
In Short…
To be an effective Project Manager, you must be capable of designing and developing the solution yourself. Otherwise, you have two opt
In Short…
To be an effective Project Manager, you must be capable of designing and developing the solution yourself. Otherwise, you have two opt
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
ions. You can either (a) ask others to make decisions for you, or (b) simply pretend you know what you're talking about. In the first case, you're a Project Coordinator. In the second case, you're a Project Mangler
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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