This document provides an overview of the process for developing a new medical device from initial ideas through regulatory approval and marketing. It notes that the process involves: 1) initial research to identify needs and potential solutions; 2) organizing funding and a company; 3) developing and testing potential solutions; 4) choosing a final solution to design and engineer; 5) navigating the regulatory process; and 6) determining marketing strategies. It emphasizes that the process takes significant time and resources.

1. Medical Device Stream
Some Tips from my Experience
By
Moshe Golan
Ceo & President
3QBD Ltd & Danor Technical Molding Ltd
www.3QBD.com

2. At the Beginning!
• Ideas, aims purposes
• The NEED, The Potential, The technology
• Initial researches, look for solution
• How, Who, What ……
• Find solutions, weigh pros and cons
• Advantages: simple to produce, easy for end user, ……
• Disadvantages: Should develop new technology, long and costy Regulation,….
• Long time to market, high total costs, special experty, ……
• Limited market!!! Patents registration!! Is it the right time?

3. The Process
• Collecting initial investment
• Preparing a presentation for investors (angels) F&F 6 month
• Organizing, founding the company
• Registration, Renting a place, preparing the tasks list 4 month
• Hiring the first employees
• Defining the needed professionals, hiring the right ones 6 month
• Starting the activity
• Purchasing the needed equipments, materials,……..
• Looking for more investments 6 month

4. Finding the first solutions
• Checking the availability of the technology
• How, where, when, how much
• Checking the regulation
• The needs, the cost, how long, the risk factor
• Checking the manufacturing
• How complex, special needs, where, who,…?
• Checking the design
• how it looks? The needs? Which?
• Do we have enough money!!
Another 2 years passed!

5. Choosing the solution
• Hura!!! Here is the final solution
• It fits the main aim, have good results, price OK,……
• Model design
• Engineering, detail designing, choosing production technologies,
Materials,……and Packaging
• Regulation!
• The list of needs? EMC, RF, sterilization? Sealing? Clinical study!
• Chief investigator, comparison tests, accuracy! Who! Where! when

6. Marketing
• What to do?
• Where to start?
• How to approach?
• Choosing Business model
• Budget size, how to raise it!
• Market Mood! Is it the right time!

7. What to outsource
• Research?
• Raising Money?
• Development?
• First devices?
• Engineering
• Manufacturing
• Clinical study and regulation
• Marketing.

8. It is all about time to market!
&
Your Resources

9. Think Before You Act
‫תחילה‬ ‫במחשבה‬ ‫מעשה‬ ‫סוף‬

10. Thanks
Questions and Answers