A Regulatory Primer
Regulatory hold-ups can delay time to market for early-phase
companies. This series
from Roger Gray of Donawa Consulting focuses on
critical regulatory hurdles that must be
overcome before medical device products can be sold
in the major world markets.
Part 1: Consider Regulatory Issues Early On
Part 2: Up Close: U.S. FDA Classes, Controls, Comparisons
Part 3: Up Close: The European Rules-Based System
Part 4: Understanding Quality System (QS) Requirements
Part 5: An Important Post-Market Requirement
Part 6: 14 Medical Device Myths and Realities
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Intelligent Intellectual Property
Israel is an intellectual property leader. Learn
more about the country's "national resource."
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 Disease Related Groups (DRGs)
Amir Inbar of MediClever takes a look at DRG coding and reimbursement procedures
in this three-part series.
An
Introduction to DRGs, Part 1
An Introduction to DRGs, Part 2
An Introduction to DRGs, Part 3: From the Company's Perspective
This series is also available in Hebrew.
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Alternative
Reimbursement Mechanisms for Medical Devices in Germany
(Part 1)
Amir Inbar of MediClever describes two
alternatives for the Disease Related Group (DRG)
codes that can help Israeli companies increase their chances
of obtaining a relevant DRG code in the future. Read Part
2 of this series.
This series is also available in
Hebrew.
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"Who's Calling Please?"
How has Israel carved out a niche in today's "flat" world?
According to Marketing Communications Consultant Karen
Kozek, through international
call centers.
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Boutiques Go Mainstream
Marketing Communications Consultant Karen
Kozek looks at
how small Israeli wineries are making a big splash internationally.
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Information in Focus
Eighteen years ago, Paula Eiblum started
Infocus Research Services near Washington, D.C. Today, this specialized
service competes with the Web itself.
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Left to Their Own Device
Why is Israel's medical device industry so successful?
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The New R&D Law Brings About a New Era
An
in-depth look the the amendment to the R&D law, which
has the potential to bring about a new era in Israeli entrepreneurship,
according to Moshe Rotem, founder of Sunrise
Projects Ltd.
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The Most Innovative Israeli Nanotechnology
Companies |
Three companies shared the first annual MI2NT award: Congratulations
to Cima NanoTech Israel Ltd, Nutralease
Ltd., and Sol-Gel Technologies Ltd.
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American Visas, Anyone? |
 Rhonda
J. Watson, deputy consul general at the U.S. Embassy in Tel Aviv,
explains what steps the embassy is taking to assist visa applicants requesting
non-immigrant travel visas.
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"Homeland Security
Opportunities" |
 This
presentation was prepared and presented by Christopher
T. Cushing, a U.S.
consultant and expert on
corporate transactions that involve complicated issues of public policy and investment.
Chris presented at the MarketReach America seminar "Raising
Money for Homeland Security" (December 1,
2004).
Read more about the seminar.
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| The Business Plan Process |
We write definitive statements in our business plans based on our understanding of what things are, how things work, what seems to make sense, and most important, our vision of how things will be.
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A Successful Summer Experience |
 "If
there's one thing I've learned, it's that the knowledge gained within the
walls of a university does not compare to the experience and knowledge gained
'on the job.'"
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Cross-Cultural Negotiation |
A leading negotiator shared some powerful negotiating tips at the intensive five-day MarketReach America ICET 2004 strategy conference in Baltimore, Maryland.
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Why Didn't I Think of That |
Good ideas don't just occur spontaneously. Sometimes they need a little prodding. Sometimes they get buried under other ideas. That's where brainstorming comes in.
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When Consulting Works
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 Special report from Trendlines Capital Markets: Israel's Security Industry. Israeli businesses have a long history of cooperation with the world's security-related companies. The report includes original articles, industry survey, timeline, and a comprehensive index of public and private Israeli security companies. |
Volumes have been written on the subject of working with consultants. D.
Todd Dollinger, Trendlines chairman, shares
the most important issues relative to working successfully with
consultants.
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Exporting in Tough Times
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The dollar has come down from its peaks, but much of the world's economy is still in a low-growth mode. Yet there is work to be done and there is money being spent out in the market.
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Trials and Errors
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Clinical trials are a veritable minefield of procedures that must be followed to the letter. Failure to comply can be extremely costly — sometimes necessitating a repeat study. The key to a successful study, according to Dr.
Yoram Rubin, begins with sound planning.
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| Of Urban Legends and Mythical Markets
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 The line between fact and fiction isn't always clear. Case in point: urban legends — stories that circulate, mutate, and are passed around as "true" — the proverbial "it happened to the friend of a friend." But it's not only urban legends that circulate and get related as fact.
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| Special Series on Patents |
| Hot Property: Digital Rights in a Digital World (Part 4) |
You've read the story, downloaded the movie, and grooved to the song. Now find out why copyright issues on the Web get some of us hot and bothered, and what can be done about it.
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Patents: The Next Generation (Part 3) |
Full of symbols and meaning: the take on trademarks.
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| Provisionally Patenting (Part 2)
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Do you or don't you? Is a provisional patent worth the paper it's written on?
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| Patent Power (Part 1)
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Play it safe. Read this introductory lowdown on the whys, whats and wherefores of intellectual property.
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| The KISS Principle
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Textbooks tell us that an executive summary is a business
plan in miniature. It should be short and use concrete facts and figures.
There's nothing wrong with the theory, but our experience tells us that it's
all about people. People who make the products. People who buy the products.
And people who invest in people. Do you have a compelling story?
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| Factor in Success |
Trendlines staff members were present at the MIT Enterprise
Forum's seminar on "Success Factors in Biotechnology — Drug Development from Concept to Prescriptions."
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| On Incubators and Incubating
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Israel's technology incubators are oases of innovative development.
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| Product Documentation: Meeting Critical Needs on a Budget
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Technical communication expert Leah Guren explains how start-ups
can produce quality documentation while staying within their budget.
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| Nondisclosure Agreements: To Sign or Not To Sign?
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When it comes to the paradoxical nature of the nondisclosure agreement (NDA), there are no easy answers but a lot of questions — the main one as basic as "Do you or don't you use an NDA?"
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| From Scientist to Entrepreneur
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How does it feel to be the scientist who must toe the commercialization
line set by the entrepreneur -- when they are one and the same person? Ronit
Sagi-Eisenberg epitomizes this contemporary phenomenon.
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| Selling Your Business — a Summary
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Steve Rhodes, Trendlines chairman, suggests that start-up companies
need to take a more businesslike approach to marketing themselves, starting
with the most basic tool of all — the executive summary.
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| Added Value from Experience
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Question: How can smart entrepreneurs turn their brilliant ideas into successful companies? Answer: By understanding their limitations and knowing where to go to find help.
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| You, the Inventor
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Got an idea for a new product? A business incubator might be the answer.
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| Incubators — a Safe Environment
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Incubator managers identify key characteristics for success.
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| Confessions of a Serial Entrepreneur |
Internet
guru Ron Lachman discusses the
Net today and an uncertain future.
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| Goodbye, Mr. Gutenberg
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Are books headed for the antique heap? Would you exchange
your hard copy for a virtual version? A confirmed bookworm looks at the issue.
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