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Regulatory Intelligence and Strategy Planning using Magellan and SaaS Technology

Title: Regulatory Intelligence and Strategy Planning using Magellan and SaaS Technology

Speaker: Mark Thomson, President and CEO, RegIQ Solutions, Inc.

Date: 09/25/2018

Brief Description:
Interested in improving your regulatory process for medical device? This presentation is on Magellan, the first SAAS regulatory compliance platform for medical devices with onboard market specific intelligence, project planning, and license management capabilities. Magellan is unique, game-changing technology and a great improvement to current regulatory practice for presubmission planning and post-market management.

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Preparing for the Ups and Downs of a Startup Company

Title:  Preparing for the Ups and Downs of a Startup Company

Speaker:  John Hendrick, CEO Mynosis

Date:  07/31/2018

Brief Description:
Mr. Hendrick speaks about the trail from concept through a market release for a medical device company. He spoke what it takes from funding through various evolutions of the company as well as the regulatory process of CE Mark and FDA approval. Additionally, he details the trials and tribulations of the attempts for reimbursement with the final outcome which was presented on July 31.

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Why dental & orthodontic product markets are more exciting than other medical device spaces

Title:  Why dental & orthodontic product markets are more exciting than other medical device spaces

Speaker:  Thomas Ross

Date: 07/24/2018

Brief Description:
Total sales and the potential markets for dental and orthodontic products are huge – and growing rapidly! Most of your medical device experiences and learned lessons are directly transferable to this exciting field. We’ll discuss regulatory, operations, sales & marketing as well as financial aspects of these markets. I’ve found the opportunities for innovation, growth and financial rewards to be significant.

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How to utilize Prescriptive Service to deliver ROI

Title: How to utilize Prescriptive Service to deliver ROI

Speaker: Ramki Pitchuiyer, CEO & co-founder

Date: 07/17/2018

Brief Description:

  • Ramki is the CEO & Co-Founder of eKryp, a Prescriptive Service application. eKryp targets aftermarket Service Operations. Prior to eKryp, Ramki co-founded Paloras. Ramki believes in connecting AI w/ Human intelligence to bring superior end customer experience. He has am MBA from the Anderson School, UCLA and a  B.S in Electrical Eng from BITS, Pilani in India.

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Protecting Intellectual Assets in the New World of U.S. IP Law

Title: Protecting Intellectual Assets in the New World of U.S. IP Law

Speaker:  Alper Ertas, JD, Venable, LLC

Date: 06/12/2018

Brief Description:
The landscape for IP protection in the United States has shifted significantly in the wake of lobbying, changes in federal laws, and precedential decisions from the Supreme Court and Federal Circuit. Many of these changes are in response to litigation practices used by non-practicing entities. Alper will discuss key changes to the laws governing patent and trade secret protection and how they affect IP strategy for developed and emerging companies in the biotech space.

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The New Generation of Cerebral Aneurysm Therapy

Title:  The New Generation of Cerebral Aneurysm Therapy

Speaker: Claire Houston, Clinical Consultant for Pulsar Vascular

Date:  06/05/2018

Brief Description:
This program covered intracranial aneurysms and challenges associated with these difficult to treat lesions. Historically intracranial aneurysms were treated with open surgery but after 2003, embolic coiling became the preferred method of treatment. There have been significant advances regarding the use, safety, and efficacy of these devices however, these
lesions remain difficult to treat for the endovascular surgeon. Specifically, this program covered the multitude of requirements it takes to bring a novel product to market to replace or improve on the minimally invasive device currently available in the US and Europe.

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Lean Startup – tactics and strategies for early stage medical device companies

Title: Lean Startup – tactics and strategies for early stage medical device companies

Speaker:  Evan Anderson, CEO, Luma Therapeutics

Date: 05/22/2018

Brief Description:
“Lean” is a popular concept in the startup world these days but there are few guidelines on how to implement it at a medical device company where hardware development is combined with a regulatory burden. I’ll share with you my personal tips/tricks for keeping the burn low while driving down risk.

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Transforming the dental implant into a bio-engineered medical device

Title: Transforming the dental implant into a bio-engineered medical device

Speaker: Issa Karkar, DDS, CEO In Pronto

Date: 05/08/2018

Brief Description:
InPronto has removed the current fundamental disconnection in the process between implant surgery and the prosthetic fabrication and placement which may not function as intended might provide inferior results, and instead solves it holistically treating the tooth as complete device, from the root tip to the cusp tip, as nature intended it and thus delivering superior results. InPronto creates a paradigm shift transforming the dental implant into a medical device and simplifying the delivery process

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Doing the Bio Biz in China – The challenges, the Rewards, and (more importantly) the Pitfalls

Title: Doing the Bio Biz in China – The challenges, the Rewards, and (more importantly) the Pitfalls

Speaker: Lu Wang – General Manager- Hefei Sageland Biotechnology

Date:  04/17/2018

Brief Description:
In this presentation, Dr. Wang will share with you the lessons he’s learned from his two successive attempts at the China Play, and some tips on how to maximize the return from such an endeavor. It begins with some historical and cultural context, then on to some practical consideration about starting an operation there. Towards the end of the talk, he will also cover Flow Pharma’s technology and its clinical activities in China, as well as some suggestions about working within China’s ever-changing regulatory environment.

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