Title:
MedTech/Biotech Startup to IPO: Roadmap to Building Secure, Compliant and Smooth Running Operations

Author:  Mark Richards, CEO KalioTek

Date:  01/29/2019

Brief Description:
By making the smart choices at every stage of growth, emerging Medtech and Biotech firms can efficiently build toward a future with smooth-running IT, strong security and compliant systems without the fire drill, expense and disruption that is often experienced when an opportunity appears for an acquisition or IPO. We’ll discuss real-world choices our customers faced by stage of growth, the solutions they chose and the results they experienced. We’ll cover practical, inexpensive solutions to the top 10 security concerns.

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Title: Dialysis. Anywhere, Anytime, Anyone.

Speaker: Steven Miller, Fellow Electrical Engineer, Outset Medical

Date: January 8, 2019

An under the covers look at the development, architecture, and market of the next generation kidney dialysis system and its possible application in natural disasters such as post-Maria Puerto Rico. This talk highlighted the development of the next generation hemodialysis system starting from a PhD project to the doorway of a $30 Billion market and into the world of natural disasters. The technology employed was discussed as well as the key events that guided Outset Medical to pivot from the home hemodialysis market to the clinical, hospital, skilled nursing faculties and beyond.

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Title:  New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety

Speaker: Matt Jorgensen, Nelson Labs

Date: 12/04/2018

Brief Description:
This presentation will provide a snapshot of a shifting regulatory landscape that is evolving with the new release of ISO 10993-1, the MDRs, and draft ISO 10993-18. An overview of the strategic options available for the evaluation of medical device biocompatibility will be provided, including the use of chemistry and biological risk assessments to save time, money, and spare animal life.

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Title: Biology Guiding Radiotherapy – Turning Cancer on Itself. Finally.

Speaker:  Cal Huntzinger, Sr Director, Clinical Development- RefleXion Medical

Date: 11/27/2018

Brief Description:
RefleXion Medical, a biotargeting oncology company, was founded to answer a simple question: if a cancer cell emits a signal, can we shoot right back to destroy it? Cal provided insights in the development and clinical applications of RefleXion’s biologyguided radiotherapy, the first to utilize the cancer itself to guide radiation delivery. The machine uses PET, the gold standard in cancer staging and imaging. The RefleXion machine senses PET emissions and rapidly responds by sending a beamlet of therapeutic x-rays toward the originating tumor. BgRT makes it feasible to track and treat multiple tumors throughout the body in the same session.

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Title:  A Rapid, Portable, Affordable, Platform Technology for The Early Screening of Breast Cancer

Speaker: Aparna Venkatesh, Vice President, Global Marketing

Date: 10/02/2018

Brief Description:

POC Medical Systems was founded to make cancer and infectious disease screening accessible and affordable on a worldwide basis. POC collaborated with LLNL to develop this test for breast cancer. This test can be performed with its portable lab-in-a-box technology. The advantage is its low cost, portable platform technology. In contrast to traditional lab-based ELISAS and mammography, the Pandora CDxTM-MammoAlert system only requires a few drops of blood and does not need to be administered by a highly trained technician. This method of ‘distributed but connected POC’ screening and diagnostics will bring a paradigm shift in medical treatment.

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Title:  Marketing Automation: These are the droids you’ve been looking for

Speaker: Debbie Donovan

Date: 09/18/2018

Brief Description:
Sending Email to customers and prospects is easy, in theory. This presentation will cover: Segmenting customers and prospects into lists and what content to send each segment. How to set expectations for responses from different segments. Discussion of products available.

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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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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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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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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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