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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Title:  How to Start a Medical Device Company

Speaker:  Richard Lotti, President & CEO, Cranial Waves

Date: 07/10/2018

Brief Description:
Rich Lotti’s presentation covers the pitfalls of starting a medical device company.

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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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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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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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Title: The Past, Present and Future of Fetal Monitoring

Speakers:  Neil Ray, M.D., Mark Rosen, M.D.

Date: 04/10/2018

Brief Description:
Civilizations have been monitoring babies during pregnancy since the times of the Egyptians. We will examine some of the methods used in the past for fetal monitoring as well as the reasons why babies were monitored. We will discuss the current methods for fetal monitoring, the limitations as well as the consequences. Finally, we will discuss the novel fetal monitoring technology that Raydiant Oximetry is developing and how this technology could improve outcomes for mothers and babies during childbirth.

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Title: The Promise and Peril of Agile for Medical Devices

Speaker: Aaron Joseph

Date: 01/23/2018

Brief Description:
Agile methods promise faster development of medical devices but at the peril of jeopardizing regulatory compliance. Learn about four key rules to follow to ensure you don’t sacrifice compliance in order to take advantage of agile methods. Aaron covered how
agile methods can lower risks, improve quality, & shorten time to market for medical device development. He also covered basic principles behind agile & lean methods & important adaptations needed for the particular needs of medical device companies.

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Title: The Next Generation In-Vivo Discovery Platform; using technology to advance and accelerate drug development.

Speakers: Larry Stevens and Abe Couse, Vium

Date: 10/10/2017

Brief Description:
Vium is a Silicon Valley start-up applying hardware, and software technology aimed at improving the efficiency of drug development. The company’s focus is on in vivo drug testing, a key step within the preclinical drug development pipeline where processes and methodologies have been largely unchanged for 30 years. Vium is developing a fully integrated platform including hardware, software, computer vision and data analytics backed by a cloud infrastructure. We will share the story of Vium’s technology and opportunities driven by our client’s needs.

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Title: Operationalizing Product Management for Telehealth Devices

Speaker:  Padmasri Bhetanabhotla, Director of Product Management, HealthExpense, Inc.

Date: 10/03/2017

Brief Description:
The talk covered how to operationalize product development for a medical device. Real life examples were presented from her experience as a Product Manager leading teams that were developing new products or making revisions to existing products. Padmasri discussed the challenges she faced and how she optimized new and existing products through the process. Finally, she will review lessons learned to help prevent from encountering some of the challenges we faced.

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