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Advice Pool - The First Himss Venture Fair -2007
I attended the new Venture Fair at the Himss Conference and applaud the organizers for launching this new event. In spite of its maiden voyage, it was very well organized, well attended an
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
d very effective. In fact, the biggest difficulty was the weather not co-operating and the morning session had a majority of entrepreneurial presenters compared with qualified investors.
; 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
y Mid Afternoon, with late arrivals, however, the ratio of investor to presenter was approximately one-to-one.
I am looking forward to attending this event at next year's conference and a
I am looking forward to attending this event at next year's conference and a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ticipate that the word will get out and attendance will triple.
If there were a disappointment, it was that only Eclipsys had a representative attending and all of the other major HIT ven
If there were a disappointment, it was that only Eclipsys had a representative attending and all of the other major HIT ven
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ors were absent. Part of that may have been because this was a brand new event. At the very least, the big guys should want to keep their finger on the pulse of the up and coming technolog
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
es. Some useful platforms were presented including a patient smart card, biometric security and a voluntary patient reported health record.
In spite of the passion and creativity of this
In spite of the passion and creativity of this
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
roup of entrepreneurs, half of them will not be around in two years. The major hospitals are not early adapters. The implementation of new technology can often be way more costly and diffi
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
ult than originally anticipated and results are not guaranteed. Combine that technology risk with the "small company risk" and the sales environment is not very welcoming.
Like the entrep
Like the entrep
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
eneurs in the room, I too want to have a positive impact on the healthcare system, but our firm is a little investment-banking firm. So I am going to apply my passion and creativity to pro
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
ose a new financial paradigm that is designed to accelerate the introduction of game changing technologies. I call this our Hybrid M&A Model. It is designed to provide the entrepreneur the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
capital to develop his or her technology toward commercial success. This new model invites the big HIT players in as venture investors.
They would acquire a minority equity interest in pr
They would acquire a minority equity interest in pr
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
mising companies with a call option exercisable at some future date at a predetermined, contractually negotiated valuation metric. Now for the hard part. They then take the role as a suppo
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
ter of their investment and tell the entrepreneur to press on as an entrepreneur. The spirit, passion, and energy of the entrepreneur remain in tact. More importantly, the efficiency of th
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
start-up remains in tact. Translation - very low overhead compared to a comparable product launch with a large company's infrastructure.
The advantages to the large company are that they
The advantages to the large company are that they
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
create a very low cost and efficient R&D platform. They dramatically reduce their financial risk of major product development failures. They also spread their risk over a portfolio of prom
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
sing technologies. If they do exercise their call option, they have actually helped the seller make his/her company more expensive. However, it is likely that their pre-negotiated valuatio
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
metric will allow them to complete the acquisition at below current market value.
The entrepreneur is able to secure much needed funding to help develop his/her vision. More importantly,
The entrepreneur is able to secure much needed funding to help develop his/her vision. More importantly,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
however, is the backing of the major HIT vendor largely removes the "small company risk" component for the risk adverse hospital decision makers. This alone will accelerate the adoption of
.
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
new technologies so they can reach the scale necessary for commercial success.
Some very smart and successful companies like Cisco Systems have deployed similar models with great success.
Some very smart and successful companies like Cisco Systems have deployed similar models with great success.
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
They recognize they do not have a monopoly on all the great new developments in their industry so they cast their net over a broad territory through this type of creative equity investment
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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