K&L Gates

The FDA recently posted final guidance documents on medical device data systems and mobile medical applications. The FDA also posted draft guidance on its general wellness policy for low risk devices and medical device accessories. If your company is involved in health data, patient data or fitness these could affect you.

Sifting through these four guidances is challenging, so why not let K&L Gates’ local FDA Attorneys digest the critical information for you? In just 90 minutes, you will learn: How to decipher the FDA’s new approach to regulating - or not regulating - innovative devices such as wearables, mobile apps designed to improve health, and data systems that are empowering physicians to provide improved patient care Which medical devices the FDA deems are of such low risk that it will no longer focus its regulatory oversight on them Which medical devices the FDA will regulate, but under a lower risk classification The grey areas and how to make sure your device remains within its intended classification

Seminar Presenters: Carol. A. Pratt, JD, Ph.D., Partner, K&L Gates LLP Mitchell E. Parrish, JD, RAC, Associate, K&L Gates LLP

Audience: Medical device and health technology professionals Wearables designers and manufacturers Fitness or wellness technology professionals Researchers and physicians *Software programmers and inventors in the healthcare field

Event Details: When: March 6, 2015 Time: 8:30am - 10:00am Where: K&L Gates, LLP, One SW Columbia Street, Suite 1900, Portland, OR 97258

Starting and growing a successful healthcare tech company is uniquely challenging and difficult Join your peers and a panel of seasoned business leaders for real life lessons learned, best practices and ways to go about managing your health tech company for the greatest success. Find out how others are overcoming the challenges of regulatory compliance, financing, operations, new technologies and more. Panel discussion will be followed by a networking reception where you can connect with other leaders in Portland’s Healthcare technology community.

Panelists and Discussion Topics

Finance

Eric Hanson, MD, MPH, Founder and CEO, Tier 7 – Eric will share information on underutilized practices to build a long-term working relationship with the Department of Defense (DoD) and perspectives on obtaining non-dilutive growth funding from the DoD and DoD subcommands.

Operations

Frank Ille, Chief Executive Officer, HealthSaas – With three start-ups under his belt and leadership experience at Microsoft and Oracle, Frank will discuss best practices from an operational perspective. Market acceptance, branding, pricing, features and other key success factors all need to come together in the right mix for a successful healthcare product or service company. Frank will share how they have learned to put these complex pieces together and build strong customer relationships.

Chris Logan, Fund Manager, PSF Founders Group and Former CEO of Sweetspot Diabetes Care – Chris led Sweetspot Diabetes through an acquisition by DexCom in an all-stock deal valued at $8.5 million. Chis will discuss what made the company attractive to buyers and the steps he took to a successful exit.

Regulatory

Carol Pratt Ph.D., Partner K&L Gates LLP – Carolis an FDA attorney who’s practice focuses on regulatory issues associated with research, development and FDA requirements that apply to bio-medical and health products – Carol will talk about the FDA’s regulation of medical software, highlighting issues associated with mobile medical applications and cloud connectivity

Moderator:

John Torterici, Chief Executive Officer, Chart Solutions The evening will end with a cocktail reception. Please note, space is limited so register today!

Event Details:

When: Tuesday, June 3, 2014

Time: 4:30 – 7:15 PM | 4:30 Check-in | 4:45 Panel | 6:00 Reception

Where: K&L Gates LLP, One SW Columbia Street, Suite 1900, Portland, OR 97258

Cost: $25 TAO Members | $35 Nonmembers

Raising capital from Angel investors can be a challenge, particularly given just 10 minutes to distill your entire business plan into a compelling presentation. What information is critical? How much detail is enough, or too much? What do angel investors consider when evaluating an investment opportunity?

Since 1999, the Program Managers at the Alliance of Angels have been coaching early-stage companies and bringing the best deals to angel investor members. Having collectively interviewed hundreds of companies, we have developed a set of best practices regarding the presentations that resonate with the angel investment community. In the 10-Minute Pitch Clinic, we share these best practices with you in an interactive workshop. Instead of learning these lessons the hard way, when you're in front of angels asking for money, consider attending our clinic first to get the inside information you need to know, now.

This workshop format will be divided into two parts. First, we will give an overview of the Alliance of Angels and discuss the components of a good 10 minute pitch. Afterwards, we will work directly with the participants on your specific start-up messaging. All you need to bring is your vision for your company and your desire to make this workshop truly participative-- no other preparation is necessary. Space is limited to 20 attendees, so reserve your spot today. The price to attend is $95 per person with advanced registration, or $110 at the door.