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Top Adding - No Bull
Gertchrude, my old milk cow was a dear soul and dependable as they come, still she was no Bull and neither is what I am about to say!
As I have transitioned my Inspection Business to Upper Michigan, I keep running into one speci
As I have transitioned my Inspection Business to Upper Michigan, I keep running into one speci
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
fic problem that befuddles me. I suppose I should tell you first that in my Market, many listed homes are vacant. Sometimes the owners live out of state, sometimes there is a death in the family and often, people leave the are
; 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
a for career pursuits (usually returning at some point). in any case, Imagine meeting a client at a property to begin an Inspection only to find that the water, Gas or Electricity have been shut off. This brings up an interesti
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ng question...several actually. You might first ask, why didn't the Inspector know the Utilities were shut off? More on that later. The next logical question might be: So the water is shut off, what's the big deal, just turn
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
it on...right? The short answer is: wrong, wrong, wrong! Lets say, for example that I do turn on the main water valve as it comes into the home. I begin by inspecting the plumbing, not difficult as I soon learn several pipes h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ve burst (home was not winterized) and there's a hole the size of Niagara Falls underneath the water heater. So, just quickly shut off the water. Not so fast, it seems the shut off valve which has been around since Moby Dick wa
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
s a minnow, doesn't...yep, you guessed it, want to shut off! The Listing Agent is unavailable and the municipal water might be able to get out later that afternoon. Now, luckily for me, that scenario has not happened, but less
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
dramatic things have. Once I make the decision to turn on any component or utility during an inspection, I have not only just assumed responsibility for damages, I have also potentially peeved a whole bunch of people if there is
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
a problem that can't be immediately fixed.
So, I could have just written up the report without inspecting the plumbing. Sure I could have. But doing so would not be fair to the client who paid and trusted me to provide a comp
So, I could have just written up the report without inspecting the plumbing. Sure I could have. But doing so would not be fair to the client who paid and trusted me to provide a comp
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
lete inspection. One month later when this client closes on the home and finds the water heater leaking, or it raining in the dining room from the hall bath above, this buyer will be hopping mad, and ultimately, it won't be me t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is client addresses his/her anger toward.
Yes, yes, but you say, why didn't you just wait until the Utilities were all turned on? Well, now here is where we truly get to the nut of this problem. You see, in my market, when a p
Yes, yes, but you say, why didn't you just wait until the Utilities were all turned on? Well, now here is where we truly get to the nut of this problem. You see, in my market, when a p
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
urchase agreement is drawn up, sometimes the Realtors don't address the issue (within the purchase agreement) of who is responsible for turning on and off ulilities prior to closing. This can cause a great deal of confusion and
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
buck passing, and I for one, don't wish to be caught in the middle. Further, as a generalized truth, I find that some Realtors (Listing Agents) are giving the buyer 10 days to have the Inspection completed and then not immediate
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
ly working toward getting all the Utilities turned on knowing they are not. It has happened (to me) more than once lately that the water or electricy was still turned off at the time the inspection contigency expired.
The only
The only
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
thing I can think of is to try to provide some guidance and experience on this issue to Realtors in my area. They need to understand that a Home Inspection Contigency, is just that, a "Contigency". Failure to allow the buyer a
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
omplete inspection within the agreed upon time frame voids..or makes voidable, the purchase agreement. If the Utilities are shut off and the Listing Agent knows this, and the listing agent also knows the home has not been winter
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
ized, it seems reasonable to assume that they may need more than 10 days to fix any forseable problems (i.e. leaks in water and NG pipes, servicing the furnace or boiler, making sure the electricity is safely turned on). These a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
re not my repsonsibilities.
I do also understand that in Michigan, there are no state standards or competency requirements for Home Inspectors...yet (more on that in another post). Personally, I adhere to ASHI standards. How d
I do also understand that in Michigan, there are no state standards or competency requirements for Home Inspectors...yet (more on that in another post). Personally, I adhere to ASHI standards. How d
.
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
o I know those standards? Well, I have been licensed in Wisconsin for nearly 9 years now. I also engage in a minimum of 40 hours up to 200 hours of Home Inspector Training classes and seminars each year. I know what Michigan I
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
nspectors should be doing, but with no standardized guidelines, there is little consistency and perhaps some Realtors are misinformed in general about the scope the Home Inspection should encompass.
And how is your weekend going
And how is your weekend going
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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