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Main Subject - In Your Best Interest
A diversified medical group suffered from a common procedure that frustrated patients, doctors and laboratory technicians every day.
First, doctors sent their patients to the laboratory for tests. After the tests, patient
First, doctors sent their patients to the laboratory for tests. After the tests, patient
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
s asked the laboratory technicians for results.
When technicians shared the test results, patients often got upset. When patients got upset, doctors got upset. Doctors preferred to explain test results to their patients p
When technicians shared the test results, patients often got upset. When patients got upset, doctors got upset. Doctors preferred to explain test results to their patients p
; 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
rsonally and offer next steps for treatment.
But if technicians did not give patients their test results immediately, patients complained that information was being withheld and claimed the laboratory technicians were unh
But if technicians did not give patients their test results immediately, patients complained that information was being withheld and claimed the laboratory technicians were unh
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lpful.
The situation was clearly lose-lose-lose: patients, doctors and laboratory technicians – everyone got upset.
(Does this ever happen in your organization? Do your customers ever become frustrated, angry or confused
The situation was clearly lose-lose-lose: patients, doctors and laboratory technicians – everyone got upset.
(Does this ever happen in your organization? Do your customers ever become frustrated, angry or confused
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
Do your staff get upset when your customers are upset? Does your brand image suffer, too? Are there ‘lose-lose-lose’ situations lurking in your business?)
The medical group asked me for help. I diagnosed the situation as
The medical group asked me for help. I diagnosed the situation as
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
a case of ‘unmanaged customer expectations’. If you were a patient, wouldn’t you want to know your test results right away?
If you were a doctor, wouldn’t you be upset if your patient knew the results before you did? If y
If you were a doctor, wouldn’t you be upset if your patient knew the results before you did? If y
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
u were a technician, wouldn’t you feel caught in the middle?
We solved this problem with a simple but powerful system called ‘In Your Best Interest’.
When doctors order lab tests, they use a printed checklist to indicate
We solved this problem with a simple but powerful system called ‘In Your Best Interest’.
When doctors order lab tests, they use a printed checklist to indicate
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
which procedures are required. At the top of the checklist, in bold letters, is now printed this statement:
‘IN YOUR BEST INTEREST, all laboratory results will be sent to your doctor who will explain them to you pe
‘IN YOUR BEST INTEREST, all laboratory results will be sent to your doctor who will explain them to you pe
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
sonally and discuss the most appropriate treatment.’
Many doctors now read this statement to their patients. Many patients read the statement themselves. Most patients understand the message, but many are so nervous about
Many doctors now read this statement to their patients. Many patients read the statement themselves. Most patients understand the message, but many are so nervous about
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
their upcoming tests, they don’t pay attention.
In the waiting room of the laboratory, a large poster now hangs on the wall. In bold letters the poster reads:
‘IN YOUR BEST INTEREST, all laboratory results will be
In the waiting room of the laboratory, a large poster now hangs on the wall. In bold letters the poster reads:
‘IN YOUR BEST INTEREST, all laboratory results will be
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
sent to your doctor who will explain them to you personally and discuss the most appropriate treatment.’
All patients can see the sign, and many understand the message. But some are so anxious about their upcoming tests,
All patients can see the sign, and many understand the message. But some are so anxious about their upcoming tests,
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
they still don’t pay attention.
After the tests are done, a small percentage of patients still ask laboratory technicians for an immediate explanation of the results. For those few, the lab technicians have been trained t
After the tests are done, a small percentage of patients still ask laboratory technicians for an immediate explanation of the results. For those few, the lab technicians have been trained t
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
say one simple sentence in a compassionate and caring manner:
‘IN YOUR BEST INTEREST, all laboratory results will be sent to your doctor who will explain them to you personally and discuss the most appropriate tre
‘IN YOUR BEST INTEREST, all laboratory results will be sent to your doctor who will explain them to you personally and discuss the most appropriate tre
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
tment.’
By this time, everyone pays attention. Patients wait to see their doctors. Doctors can fully inform their patients. And laboratory technicians can do their job compassionately without getting caught in the middle.
By this time, everyone pays attention. Patients wait to see their doctors. Doctors can fully inform their patients. And laboratory technicians can do their job compassionately without getting caught in the middle.
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
That’s a ‘win-win-win’ for everyone.
Key Learning Point
--------------------------------------------------------------------------------
Customers may become confused or frustrated by your policies and p
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
ocedures. This is especially common in large organizations. But it’s not productive to blame your customers or your colleagues – that only makes things worse.
What is effective is to resolve the situation permanently by i
What is effective is to resolve the situation permanently by i
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
proving the clarity and consistency of your communications.
Action Steps
--------------------------------------------------------------------------------
Find a point of friction where your customers or c
Action Steps
--------------------------------------------------------------------------------
Find a point of friction where your customers or c
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lleagues get upset. Choose a tension point that has persisted for many months. Do people complain about your applications and procedures? Are your policies hard to understand? Is your guarantee confusing? Have your systems
.
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
grown slowly out-of-date?
There may be good reasons why your policies and procedures were created. But the explanation may be missing today or the reason may no longer apply. In either case, you can improve the situation
There may be good reasons why your policies and procedures were created. But the explanation may be missing today or the reason may no longer apply. In either case, you can improve the situation
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
ramatically by enhancing your communications, streamlining the procedure or changing the policy itself.
It makes good sense to fix whatever you can, whenever you can. After all, ‘win-win-win’ is also in your best interest
It makes good sense to fix whatever you can, whenever you can. After all, ‘win-win-win’ is also in your best interest
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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