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E-Folder - Lack of Integration = Customer Frustration
I purchased a video-conferencing unit to connect my office visually with clients all over the world. To use the equipment I need a high-speed telephone line. ‘No problem,’ I
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
thought, ‘I’ll just call the telephone company.’
The telephone company referred me to the ISDN Department for high-speed access. The ISDN Department referred me to an outs
The telephone company referred me to the ISDN Department for high-speed access. The ISDN Department referred me to an outs
; 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
de vendor who faxed me an application form from the telephone company!
I filled out the forms and faxed them back to the vendor. He faxed them back to the ISDN Department,
I filled out the forms and faxed them back to the vendor. He faxed them back to the ISDN Department,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
who then called me to arrange an appointment. But the appointment is only to ‘lay the line’. A second appointment is needed after that to ‘commission the line’. In between t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ese two appointments, the vendor must come once again to install special ‘terminator’ equipment. Phew!
As I was ordering high-speed access for video-conferencing, I conside
As I was ordering high-speed access for video-conferencing, I conside
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
red using the same line for high-speed access to the Internet. The vendor faxed me another form from a different department of the telephone company (the Internet Access Dep
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
rtment), which I filled out and returned to the vendor. The vendor faxed the form to the Internet Access Department.
The Internet Access Department called me to clarify my
The Internet Access Department called me to clarify my
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
decision. Was I aware of the extra charges? Did I know the line was not toll-free like my current analog line? Had the vendor explained that I needed yet another piece of sp
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cial equipment. Phew!
I asked whether it was better to use ISDN for high-speed Internet access, or should I use ADSL or cable. The person from the Internet Access Departmen
I asked whether it was better to use ISDN for high-speed Internet access, or should I use ADSL or cable. The person from the Internet Access Departmen
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
t said I had to speak to the people in the ISDN Department for a comparison, but the lady at the ISDN Department didn’t know anything about ADSL. In fact, she said, the ADSL
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Department was ‘a different company’. When I reached the ADSL Department (which is very much part of the same telephone company), I became quite overwhelmed trying to compar
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
e installation charges, monthly charges, toll vs. toll-free charges, monthly plans with hourly rates, and per minute charges above the monthly plans.
‘And do you realize,’
‘And do you realize,’
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 asked, ‘that you can use ISDN for videoconferencing and Internet access, but cannot use ADSL for Internet and video-conferencing without installation of another special 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
erver?’ Phew!
No one at the telephone company could help me compare. The most helpful person was the outside vendor.
Finally, I gave up.
Key Learning Point
--
No one at the telephone company could help me compare. The most helpful person was the outside vendor.
Finally, I gave up.
Key Learning Point
--
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
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This telephone company desperately needs one point of contact to educate and serve custome
This telephone company desperately needs one point of contact to educate and serve custome
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
rs in a user-friendly way. This single point of contact should be connected and empowered (internally and externally) to make all necessary arrangements for sales, installat
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
on, commissioning, selection of new equipment, scheduling of appointments, questions about billing…even customer training after installation, if required.
The critical iss
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ue is not cost. People are willing to pay for value-added services. The critical issue is convenience for the customer.
PS: This telephone company is about to get a major n
PS: This telephone company is about to get a major n
.
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
w competitor. Watch out!
Action Steps
--------------------------------------------------------------------------------
Now look at your procedures and proc
Action Steps
--------------------------------------------------------------------------------
Now look at your procedures and proc
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
esses from your customers' point of view. If your system is disjointed, unclear or confusing, your customers are going to have a problem. Which means you have a problem, too
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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