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Useful Advices - Desperate Architects: Want to Know a Secret About Architectural Drafting?
It’s about twenty after 9, on a Tuesday morning, Mike Johnson is an architect and he's thinking that life is bed of roses. But it wasn’t like that a year ago…
This time last year, t
This time last year, t
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
he revenues of his practice were shrinking at an alarming 15% annual rate… he was trying everything in the book to pull those revenues out of tailspin, primary of which was outsourc
; 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
ing most of his CAD drafting offshore. That exercise failed miserably, and he couldn’t even start to figure out why.
He had been very diligent in selecting the service provider (who
He had been very diligent in selecting the service provider (who
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
was based in India)… got custom samples done, and ramped up slowly to midsize assignments, to the point where the service provider successfully drafted a 120,000 square-foot, mixed-
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
use project in Miami…
Bertie Spalding, Mike's Project Manager for the Miami job, was impressed with their work. He decided to move the service provider even further up the ladder of
Bertie Spalding, Mike's Project Manager for the Miami job, was impressed with their work. He decided to move the service provider even further up the ladder of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
design complexity.
Mike had just been awarded the design of a 1,250-room luxury hotel in a major metropolis. He decided to ask the service provider to draft the lobby, restaurants
Mike had just been awarded the design of a 1,250-room luxury hotel in a major metropolis. He decided to ask the service provider to draft the lobby, restaurants
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
and service areas. He put Henry Kluger, one of his middle-level architects, in charge of the outsourcing activity.
But the service provider kept doing it wrong; they couldn’t keep u
But the service provider kept doing it wrong; they couldn’t keep u
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
p with the schedules and Mike missed several important deadlines with the customer. He ended up hiring 18 temporary draftsmen at $40 an hour to finish the schematic drawings inhouse.
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
This set the project back by a whole month. The customer, justifiably angered, withdrew the design contract from Mike's firm, moved to one of their competitors and left Mike in a h
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
ole $32,000 deep.
Mike was surfing the net around that time looking for tips on refinancing his house when he saw an article on outsourcing CAD. “Give the service provider good tech
Mike was surfing the net around that time looking for tips on refinancing his house when he saw an article on outsourcing CAD. “Give the service provider good tech
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
support or perish”, it said. Hmmm… Mike thought he had given that support, but in any case decided he would ask the service provider their feedback.
The results were shocking… Henr
The results were shocking… Henr
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
y Kluger had not responded to their questions in time and on some occasions not at all. The service provider had navigated a storm without instruments. “Give us good support and we c
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
an do anything,” they said.
Mike decided to give the service provider another chance. This time it was the County Civic Center, half a million square feet downtown. Mike asked the s
Mike decided to give the service provider another chance. This time it was the County Civic Center, half a million square feet downtown. Mike asked the s
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
ervice provider to draft the atrium, the shopping mall and the auditorium. Bertie Spalding coordinated from Mike's end and Mike carefully watched over the communication with the serv
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
ice provider.
Bertie answered each of their questions in detail and on the same day. He talked to the service provider on the phone several of times a week. The service provider use
Bertie answered each of their questions in detail and on the same day. He talked to the service provider on the phone several of times a week. The service provider use
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
d collaboration software to show Bertie its monitor screens in real time. Mike's software technician took care of the mechanics of uploading and downloading.
The work flew and Mike
The work flew and Mike
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
completed it before schedule. The customers were so happy that they promised Mike the design of the County Hospital as soon as the funding was in place.
Mike's firm now thrives on i
Mike's firm now thrives on i
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ts outsourcing expertise. Also, Mike's getting known as “the county building specialist.” The smell of roses is all over his office.
So be seized of the secret: “Give your arc
So be seized of the secret: “Give your arc
.
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
hitectural drafting service provider good tech support and good communication if you want the relationship to stay meaningful and effective”.
Good luck and have a blast!
(T
Good luck and have a blast!
(T
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
his story is based on a true incident; names have been changed to protect the privacy of people and firms as well as the confidentiality of projects.)
Copyright 2005 The Magnum Grou
Copyright 2005 The Magnum Grou
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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