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Sustained growth
depends on a clear grasp of market opportunities, and the evolution of
existing products and services. We have thorough knowledge and
expertise in all facets of new product development, from idea generation
and technical, business feasibility of the new opportunity, to product
design and development, to process development and product market testing,
to product manufacture and launch, since 1980. These include: Idea
generation; User needs establishment; Invention; Patenting; Technical and
business feasibility; Modeling and prototyping; Design specification; Claims;
Process pilot line; Manufacturing scale-up; Experimental design; Project
management; Accelerated aging, failure analysis and stress testing;
Clinical trials; FDA submissions; Product launch; On site project reviews;
Training seminars and work shops.
In July 1999 we chaired
the "Biotechnology and Pharmaceutical Patents, Licensing, Trademarks
and Intellectual Property" conference in San Francisco, CA. Our
presentation was titled "Intellectual Property Valuation and
Technology Transfer" and its main points included:
- How do I evaluate the
value of the technologies I have?
- How do I find a
prospective market?
- Should I find an
"agent" to help me find buyers?
- How do I approach a
prospective buyer?
- Should I
"tailor" my technology for a potential buyer?
- How do I go about
negotiating the terms of the contract?
- What are the pitfalls of
technology transfer? What is the "right" Royalty Rate for my
new technology, product?
In
December 1999 we presented a seminar on "Technology Transfer -
Developing an Effective Documentation Management System" in Atlanta,
GA. The main points of the presentation included "How To:
- Develop technology
transfer strategy and action plan.
- Utilize breakthrough
methods for incorporating validation principles into technology
transfer operations.
- Develop a link between
customer and manufacturing lab.
- Ensure a cGMP compliant
work-flow; Manage the life-cycle of your data.
- Document, manage and
audit the technology transfer process.
- Assess the financial and
economic advantages of successful technology transfer.
- Protect confidential,
proprietary trade secrets and technology from inadvertent disclosure.
- Determine pitfalls and
successes during the transfer/scale-up and manufacture of a bulk
therapeutic.
We
have devised an analytical method for selecting, designing, developing, and
manufacturing the "right" product. We have saved companies
millions of dollars and precious time by terminating new product development
projects that lacked business and/or technical merit. We have also
accelerated the development and commercialization of numerous, worthy new
products by re-focusing the limited resources of a company.
This proprietary new
product development tool interrelates quantitatively the needs of the user
with product features/benefits, design criteria and specifications, and
manufacturing conditions. In addition, we have developed a simple but
powerful new product development project evaluation method that incorporates
154 market, technology, manufacturing, distribution, legal and other
related criteria.
We have worked with
products that include: portable blood gas analyzer and contaminated needle
destruction units; antimicrobial and thromboresistant coatings; surface
treatment technologies for various types of catheter and wound management
products; drug transdermal delivery products; new generation diabetes
monitoring device; heart valve product concepts; collagen hemostats; wound
management products; various surgical cutting instruments; blood
collection, analysis and diagnosis products; cardiopulmonary and
cardiovascular products; liquid and cream sterilant, disinfectant and
cleaner products; drainage and wound closure products; surgical and
ophthalmology cutting instruments; membranes and filtration products;
liquid, gel, cream and paste products; human and hospital waste products;
surgeons and examination gloves; bone graft plaster formulation;
pharmaceutical products; pregnancy test products; dental and surgical
implant products; sterile injectables; laparoscopic devices; containers of
soft drinks; insulated windows; copiers; diapers, female hygiene and
incontinence pads; environmental soil sampling products; etc.
We have assessed both
the technical and business feasibilities of numerous product ventures.
These include a portable blood gas analyzer and contaminated needle
destruction units, antimicrobial and thromboresistant coatings, and
treatment technologies for various types of catheter and wound management
products, a drug transdermal delivery product, new generation diabetes
monitoring device, heart valve product concepts, collagen hemostat, wound
management product line and various surgical cutting instruments.
We also have been
directly involved in the development of product design criteria,
specifications, and testing. We have developed and executed protocols
for the evaluation, real life, simulation and accelerated aging, validation
and stability of both materials and overall products. We have applied
our knowledge of reliability quantification, failure distributions, failure
mode and effect analyses, maintainability and statistical data analyses to
a number of products. We have a thorough understanding of 510K, PMA,
IDE, GMP and FDA/MHW regulations. In addition, we have interpreted
patent claims and interacted with attorneys to determine if a given idea
could be patented without the potential of its interference and or
infringement with other patents.
We also have
developed and been using successfully the following powerful, proprietary
tools:
Intellectual
Property Due Diligence technical and business feasibility template.
Opportunities Assessment template.
User needs, perceptions and preferences; product claims and design
specifications template.
New product development project management template.
Process development and validation templates.
Examples
of our work include:
- Assisted sutures
manufacturer improve by 52% and 15% respectively its quality and
cost. The cleaning, siliconization and drying cycles were
reduced to two from twenty four hours. Resulted in $1 million
annual savings. Helped medical device manufacturer eliminate a
chronic liquid filling product defect and increase its production rate
by 20 fold. Resulted in $300 thousand annual savings.
- Assisted plastic bottle
closures manufacturer resolve chronic quality defect. Made
tooling and equipment modification recommendations which resulted in
the renewing of long term purchasing contract with previously unhappy,
key customer, valued at $3.5 million. Assisted high speed color
copier equipment manufacturer resolve stubborn contamination
problem. Established chemical nature of contaminant and recommended
solution alternatives. Annual cost savings at $370 thousand.
- Helped diagnostics
instrument manufacturer improve by 125% rehydration of multi-component
powder reagent. Directed the optimization of both the client’s
and its vendors’ manufacturing processes by adjusting granule particle
size distribution, bulk density, mixing, concentration and drying of
reagent mixture. Assisted liquid medication manufacturer resolve
chronic product defect. Recommended surface treatment
technologies for modifying wettability and spreading of utilized
liquids and help company improve by 28% product quality. Resulted in
$2.5 million annual savings.
- Developed outsourcing
manufacturing strategy for cardiovascular products manufacturer.
Presented advantages and disadvantages of each recommended option and
helped in the establishment of new manufacturing plan.
- Improved by 32% sharpness
of needle for blood gas syringe at manufacturing plant of a sister
division. Resulted in timely launch of "Precision
Glide" worldwide advertising campaign and turned around
politically explosive situation. Improved by 35% dissolution of
lyophilized heparin powder for blood gas syringe. Optimized
granule particle size, binders, concentration and freeze drying
parameters. Resulted in timely launch of new product, a $10
million market opportunity.
- Improved by 50% quality
of blood collection tubes with computer model predicting
performance. Established and controlled silica powder’s
particle size distribution and agglomeration, the most important
process parameters. Resulted in $2 million annual savings.
- Identified and satisfied
unmet needs of customer by inventing and completing quantitative
competitive evaluation of suction catheters and membranes for suction
canisters. Solved air flow restriction and sealing problems,
which reversed $500 thousand product back orders. New
advertising campaign resulted in $5 million sales gain. Qualified PVC
suction catheter kits for radiation sterilization. Evaluation
schedule compressed from twelve months to six. Resulted in $125
thousand annual savings.
- Qualified new bottom web
for sterile solution tray with high volume form/fill/seal packaging
equipment. Help redesign and build packaging dies in three
months. Reduced tubing and adapter costs of suction catheter by
$175 thousand annually. Solved seventeen year old extrusion and
molding problems.
Here
are some enlightening statistics
and other data that you should definitely check out about the
mortality and overall commercialization success rates of new product
ideas, prototypes, manufactured products, marketed products, etc.
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