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Digg It - Seeing the Forest and the Trees
"Only the spoon knows what is stirring in the pot."
-Sicilian Proverb
Production as a System
Production information systems are comprised of firewalls, servers, software, users, data, state and more. The combination of these individual compon
-Sicilian Proverb
Production as a System
Production information systems are comprised of firewalls, servers, software, users, data, state and more. The combination of these individual compon
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
ents creates a mind-boggling array of possibilities that exist only in the production environment.
Yes, it is complex. But more than that, when you add all those pieces together you have something new - a system. Systems theory states that the interaction of component parts creates an entity distinct from
Yes, it is complex. But more than that, when you add all those pieces together you have something new - a system. Systems theory states that the interaction of component parts creates an entity distinct from
; 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
the combination of parts themselves. The whole literally is greater than the sum of its parts.
One important characteristic of a system is that you cannot recreate it. Take a forest for example. A forest is a system comprised of trees, soil, insects, animals and so on. If you take those same components and
One important characteristic of a system is that you cannot recreate it. Take a forest for example. A forest is a system comprised of trees, soil, insects, animals and so on. If you take those same components and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
try to recreate that forest, you won’t be able to. The climate, watersheds and environment also are part of the forest.
Production systems are the same way. A production system cannot be fully recreated in the test lab. Anyone who has worked with software developers knows this from first-hand experience. Th
Production systems are the same way. A production system cannot be fully recreated in the test lab. Anyone who has worked with software developers knows this from first-hand experience. Th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
plea often heard is “My code works just fine on my workstation” when it doesn’t work in production.
Another distinguishing feature of a system is how it responds to change. Cause and effect are not always intuitive. Even small changes may produce unexpected results. A new species of insect in a forest may
Another distinguishing feature of a system is how it responds to change. Cause and effect are not always intuitive. Even small changes may produce unexpected results. A new species of insect in a forest may
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
cause an explosion in the growth of underbrush that in turn makes the forest more susceptible to fire. Network administrators may update the firmware on the firewall to accommodate a feature associated with a new software release. The new firmware has a security feature that blocks certain types of users at the firewall
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
However, everyone assumes the problem is with the new software release so it is rolled back, yet the problem persists.
Points of View
When you look at a forest, what do you see? Do you see trees? Do you see shades of green? Or do you see the beauty of a complex system at work?
Points of View
When you look at a forest, what do you see? Do you see trees? Do you see shades of green? Or do you see the beauty of a complex system at work?
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
Let’s take a moment and pull over at a splendid scenic viewpoint overlooking our production system. We just happened to bring a carload of coworkers along with us. As we stretch our legs and take in the panoramic vistas, here’s a sample of what is heard from the group.
Software Developer:
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
br>
"Wow. Will you look at all that software! And over there – more software! See that one passing a file descriptor across the process boundary? I wrote that. And see that area over there with all the tangled threads? That’s the old software that was written before I got here.”
Network Designer:
Network Designer:
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
"Wow. Check out all the packet flocks flying in perfect formation. I designed the flight paths myself. Hey, what are those fragments doing over there? Let me grab the binoculars and check out their ninth octet. Too bad, we just missed their last hop.”
Business Manager:
"Wow. You can
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
eally see the growth in recurring users from up here. If we hit our third quarter numbers, we’re going to have to increase our capital expenditures in the next budget to keep up with the demand. Hard to imagine there was no revenue here just a few years ago.”
Customer:
"Wow. So this is where
Customer:
"Wow. So this is where
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
all of our critical financial data is stored. Hey, what would happen if there were a fire?”
Seeing the Forest and the Trees
If you have a lot of information without grasping the bigger picture it could be said that you “can’t see the forest for the trees”. If you understand the gis
Seeing the Forest and the Trees
If you have a lot of information without grasping the bigger picture it could be said that you “can’t see the forest for the trees”. If you understand the gis
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
of things without having mastered any of the details it could be said that you “can’t see the trees for the forest”. These clich?s apply to any system. Is there a way to see both the forest and trees?
1. Add Context to Reporting.
Monitoring and reporting on your production system is vital. However,
1. Add Context to Reporting.
Monitoring and reporting on your production system is vital. However,
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
reporting on the right information can be harder than it seems.
Are you using pre-fabricated “canned” sample reports? Or have your reports been specifically designed to capture the things that are truly of interest?
Re-visit old scheduled reporting routines. Communicate with the people actual
Are you using pre-fabricated “canned” sample reports? Or have your reports been specifically designed to capture the things that are truly of interest?
Re-visit old scheduled reporting routines. Communicate with the people actual
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
y receiving the reports. What information is relevant? What is missing? Narrow down reporting to focus out what is useful, not just what the reporting software can do.
2. Do Modeling.
Though it is impossible to completely duplicate a production system, that doesn’t mean you can’t model it.
2. Do Modeling.
Though it is impossible to completely duplicate a production system, that doesn’t mean you can’t model it.
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
r>
An ideal testing setup will include a test lab and a pre-release staging platform. The servers in the test lab should be configured as close as possible to the actual production servers. One common problem is security configuration. Developers often write software using full root or administrator privileges, and th
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
n attempt to add security later. Security should be integrated from the beginning in a way consistent with how it will be on production.
The staging platform should be located on the production network. Testing software on a pre-release staging platform in the production environment helps pinpoint problems
The staging platform should be located on the production network. Testing software on a pre-release staging platform in the production environment helps pinpoint problems
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
that crop up only in production. Operating system and security hotfixes can also be tested on the staging server to ensure compatibility with application software before being rolled to the production servers.
3. Change Slowly.
We’ve already learned that systems are sensitive to change. Even small
3. Change Slowly.
We’ve already learned that systems are sensitive to change. Even small
.
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
hanges can cause drastic consequences.
To minimize the impact of change, minimize changes. In other words, don’t go changing a bunch of things at the same time.
How often do you hear someone say “Well, since I’m having a heart bypass I may as well get my appendix out while I’m at it”? A major a
To minimize the impact of change, minimize changes. In other words, don’t go changing a bunch of things at the same time.
How often do you hear someone say “Well, since I’m having a heart bypass I may as well get my appendix out while I’m at it”? A major 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
pplication software upgrade over a holiday weekend is not a good time to upgrade the firewalls too.
Only change one thing at a time. By changing slowly, you allow the system a chance to absorb the changes. If something goes wrong, you’ll have a better chance at diagnosing the problem and recovering from it
Only change one thing at a time. By changing slowly, you allow the system a chance to absorb the changes. If something goes wrong, you’ll have a better chance at diagnosing the problem and recovering from it
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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