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Suggest - Home Inspections: No Guarantees
Since we opened our doors in 1994, we have taken a very liberal approach with clients who claim to be unhappy with our service. But over recent years we have seen a steady shift in some of our clien
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
ts’ expectations. Their demands are higher, which is fine… but the number of clients with unrealistic expectations has grown from maybe one in five hundred, to one in fifty.
These are the people wh
These are the people wh
; 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
renegotiate their house purchase based on the inspection results – then anything, and we mean anything, that goes wrong after they move in - is the home inspector’s fault! They argue that they coul
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d have negotiated a lower purchase price if they’d been aware of the problem (or perceived problem.)
"Had you told me, I would have had the seller fix it." Lists of “problems” include items such as
"Had you told me, I would have had the seller fix it." Lists of “problems” include items such as
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
a missing latch on a screen door, missing caulking around a window, and a broken electrical outlet behind the china cabinet. These “problems” all cost less than $100 but the client insists the inspe
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
tor should have noted them. And they would like the home inspector to pay!
Then there are the clients who bought an older home with original, but serviceable windows. They have called four window
Then there are the clients who bought an older home with original, but serviceable windows. They have called four window
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
contractors and guess what? All four say they need new windows. How could the home inspector miss this $10,000.00 “problem?”
Still others find hidden problems which they readily admit the seller e
Still others find hidden problems which they readily admit the seller e
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
fectively concealed, but which the home inspector should have nonetheless discovered. “Why else would they put down new carpet? Didn’t the fresh paint make you suspicious? You should have predicte
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d they were hiding something!” On one occasion a homebuyer asked an inspection firm to pay $22,000 to dig up around his house to waterproof it and replace the drainage tiles. His basement was not w
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 but he claimed it “felt” damp. Three waterproofing contractors had all insisted “excavation is the only way to fix this problem.”
We are convinced that the quality of our inspections has not slip
We are convinced that the quality of our inspections has not slip
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ed. We firmly believe that this is a shift in customer expectations and philosophies.
We had a choice to make. We could have taken a very heavy handed approach to our inspections. This would incl
We had a choice to make. We could have taken a very heavy handed approach to our inspections. This would incl
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
ude coming down hard on every potential problem and writing "cover-your-butt" reports. We could never offer "most-likely scenarios", but only "worst possible case" predictions, if we offered any pre
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
ictions at all.
During the course of a home inspection, we are offering more than just the facts. We are offering a professional opinion. If we offered just the facts, it would go like this: "The
During the course of a home inspection, we are offering more than just the facts. We are offering a professional opinion. If we offered just the facts, it would go like this: "The
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
furnace is working today.” (We would have no opinion as to how old it is or how long it might last, or what your options are when it comes time to replace it, or what a new one might cost.) We mig
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
t conclude “The basement is dry today.” (However we would have no opinion as to what it will be like in the spring, or what minor improvements you should make to avoid a future problem.)
Our opinio
Our opinio
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
s will sometimes be wrong because we don’t have all the pieces of the puzzle. Often, some of the pieces are concealed. If we were allowed to tear the house apart, we might sometimes come to differe
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
nt conclusions. Other times, our opinion might simply vary from another expert or a contractor.
Instead of writing heavy-handed or no-opinion reports, we decided to keep our reports as even-handed
Instead of writing heavy-handed or no-opinion reports, we decided to keep our reports as even-handed
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s possible and make sure every client signs a detailed contract. The contract is intended to protect us against the unreasonable client.
Unrealistic clients don’t view a home inspection report as a
Unrealistic clients don’t view a home inspection report as a
.
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
professional opinion. They view it as an insurance policy with a zero deductible and no annual renewal costs! To allow us to continue to provide good quality, even-handed reports to the forty-nine
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
out of fifty people who deserve them, we have been forced to utilize a contract that makes our clients know, in no uncertain terms, that the inspection is an opinion and not a warranty or a guarantee
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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