Keynote
At the Cutting Edge of Digital Health (Sponsored by MedExec Women)
Digital health solutions are entering clinical practice, and while they may have shorter development cycles than physical medical devices, the path to adoption can be just as arduous and long. Our panel of experts, all brought together by the MedExecWomen organization, will discuss the keys to driving adoption of SaMD and digital solutions into medical practice.

Moderator
Maria Shepherd – President of Medi-Vantage and Co-Founder of MedExecWomen

Panelists:
Teresa Prego, Chief Commercial Officer, Nile
Mira Sahney, President, Pelvic Health, Medtronic
Jill Schiaparelli, CEO, Avation Medical

Materials
Next-Gen Surgical Implants - Improved Design with Novel Materials & Manufacturing Methods Panel Session
There are numerous novel materials, to include alloys and polymers, being considered that offer a range of properties in terms of performance attributes for surgical implants like coronary stents and joint replacement. These materials help design teams manage expectations for demographic characteristics and provide for personalized solutions for patients. This panel will discuss developments arising in both the material domains, as well as the flexibility provided by additive manufacturing for creativity in design and structure for increased functionality and superior performance.

Artificial Intelligence / Machine Learning in the Medtech Industry
Machine learning and other forms of artificial intelligence are rapidly gaining use and acceptance in the medtech industry, to the extent that there is a pathway for FDA approval specifically tailored to technology that involves artificial intelligence. The talk will be organized into three sections: the first part is an introduction that covers the basics of AI/ML and a look at the evolution of surgery to “Surgery 4.0”; the second part covers some examples of AI/ML in medtech; the third part discusses the regulatory pathway specific to AI-based solutions. The talk will also touch on some additional topics such as validation, avoiding unpredictable results, and explainable AI.

Start-ups
Panel: What Entrepreneurs Need to Know About Investment Funding for the Medtech Sector
All startups require financing, and the sources of that financing vary depending on the need, stage and type of enterprise. This panel brings together a spectrum of investors including angels, traditional VC and Corporate VC to discuss the challenges and opportunities unique to the medical device space.

Panelists:
Bruce Lichorowic, President, Galen Robotics
Salvatore Viscomi, MD, Chief Medical Officer, Goodcell
David Vogel, Managing Partner, Kayon Partners

Keynote
Cybersecurity: Unworkable Today, Hope for Tomorrow
The current process of including cybersecurity in a medical device system is broken. This is mostly due to the huge shortfall of embedded cybersecurity experts. So manufacturers are left with staff engineers making mistaken assumptions about secure designs that don’t align with regulatory expectations, standards, project goals, or attackers’ capabilities. Christopher will present one approach for abandoning this current broken model for secure design and adopt a new approach to designing security into your next medical device. This new approach aligns with the intent of regulatory standards, doesn’t require staffing up with expensive and hard-to-find embedded cybersecurity experts, and improves the overall speed of the development process.

Speaker: Christopher Gates, Director of Product Security, Velentium