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A Snapshot of the 10x Medical Device Conference

A Snapshot of the 10x Medical Device Conference


10x Medical Device Conference 2016What do you get when you take medical device enthusiasts from across the country and abroad and place them in a scenic location for three days in sunny San Diego? The 10x Medical Device Conference. In its fourth year, 10x is the annual networking event of LinkedIn’s Medical Devices Group. The event, which took place May 2-4, 2016 at the Courtyard San Diego Airport, is the brainchild of Joe Hage, a medical device marketer with a penchant for bringing people together.  On the first day of the event, conference goers were treated to workshops, a keynote speech, and the manufacturers’ showcase. In the morning, attendees heard from consultants Robert Packard, Nancy Knettell, and Maren Nelson about the intricacies of a 510(k) FDA submission. The 510(k), required for class II medical devices, shows that a medical device is safe and effective for human use.  Knettell particularly spoke about software documentation requirements for a 510(k) submission. “Your software is a death dealing X-ray,” Knettell quipped, reiterating that even though software isn’t implanted in the body, its documentation is just as important as that of an implantable device.

Medical device reimbursement was another workshop topic. As insurance costs skyrocket and insurers become stricter on what they will cover, reimbursement is now more important than ever. Nicholas Anderson, an analyst at Intermountain Healthcare, explained that many product manufacturers do a poor job at showing clinical utility, which insurers require to pay for a medical procedure. Anderson explained that in the case of one product, only one in 58 patients benefits from the treatment. If the insurer pays $600/treatment, that’s almost $35000 in costs to the insurer!

During the afternoon session, attendees learned about neuro sales and marketing strategy. Mike Sperduti, the workshop’s facilitator, is a serial entrepreneur who has sold two companies. He teaches people how to approach potential customers to generate greater sales. Sperduti advised attendees to focus on customers’ communication styles. Visual, auditory, kinesthetic, and digital communicators must be approached differently to get their attention and sell to them. For instance, according to Sperduti, digital communicators want to see clinical data, independent reports, and white papers before making a sales decision. Auditory communicators are swayed by testimonials from those they trust. Sperduti even told the audience about language to use when addressing different communicators. For auditory communicators, he suggested using words that connote sound, like “I’ll talk to you later,” “Does that sound good to you?” and “I hear what you’re saying.” If you don’t know the communication style of the person you’re contacting, use all of them! 

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How Entrepreneurs Learn to Build a Startup

An interview with Kimberly Davis King, co-director StartR and mystartupXX programs, Rady School of Management UCSD

by Amy Duncan, Goldfish Consulting

A veteran in the world of venture capital, Kimberly Davis King now focuses on investing and mentoring startups and high growth companies. With academic credentials that include a BS in industrial engineering from Stanford University and a MBA from the Harvard Business School, Ms. King is currently a lecturer at the Rady School of Management at University of California, San Diego (UCSD) where she also co-directs the student accelerator programs, StartR and mystartupXX, among other leadership roles and non-profit board positions she holds through the San Diego community.  

The Rady School of Management is an ideal environment for Ms. King. While this graduate-level business school offers an MBA as well as other business degrees, the MBA curriculum places a special emphasis on issues faced by innovation-driven companies. Its signature program is called Lab to Market (L2M), a year-long course series that teaches students how to perform market research and feasibility studies, and develop a business plan and go-to-market strategy. “After that experience many of those students want to start their own companies,” said Ms. King. “But they are still going to school or working other jobs and often not able to get into traditional accelerator programs.” In 2013, a group of students identified this gap and suggested that the Rady School have their own accelerator program. The Dean asked Lada Rasochova, PhD, and Ms. King to help start StartR.

StartR is a free, non-profit accelerator program for Rady students and alumni designed to provide entrepreneurs tools to start and grow their businesses. The program includes workshops, mentoring, advice, and access to other resources for early-stage companies. At the conclusion of the six-month program, teams present their pitches at Demo Day, attended by investors and industry experts in the San Diego community.

“Every six months we have a cohort of six teams that go through the StartR program,” said Ms. King. “They come in with the idea, and we help them get their business off the ground. They incorporate the company, raise money, and many have generated revenue.”

Two stand-out companies that completed the StartR program are Aira.io and Alpine Labs. Aira.io uses Google glass-like technology worn by the blind that connects to remote agents who provide assistance in navigating the world around them. They’ve raised over $2.25 million in venture funding and have the product in beta-testing. The Alpine Labs product, Michron, allows affordable time-lapse photography using common DSLR cameras. The company has had three successful Kickstarter campaigns, recently raising $1.2 million, the highest amount any UCSD group has raised on Kickstarter.

The mystartupXX program was created by Dr. Rasochova and Rosibel Ochoa, PhD, from the von Liebig Entrepreneurism Center at UCSD. “They created mystartupXX to encourage female entrepreneurship in technology,” said Ms. King. “During the nine-month program, participants attend workshops on team building, leadership, market assessment, market research, creating a value proposition, validating business models, and understanding financing strategies needed to launch the business.”

One notable company that completed the mystartupXX program is Cypher Genomics, founded by Ashley Van Zeeland, PhD. Cypher Genomics enables scalable, automated genome interpretation of next generation sequencing data for diagnostics development and biomarker discovery. The company was acquired by Human Longevity in November 2015.

“We welcome SDEE members to become involved with StartR and mystartupXX,” said Ms. King. “Only one member of the management team needs to be a current Rady student or a Rady alumni to participate in StartR.” A great way to meet Rady students and entrepreneurs is to attend Demo Day on March 30, when the StartR teams present their pitches. Both programs have a competitive application process to select participants. The Spring 2016 StartR program closes on April 10th. The next application period for mystartupXX is the Fall 2016. To learn more about StartR and the Demo Day, click here. To learn more about mystartupXX, click here.


Working on Your 2015 Taxes? Here Are Some Helpful Tips for Entrepreneurs.

It’s that time of year again. Tax day (April 18) is approaching. Get your receipts ready and your tax preparer on speed dial! Want some tips to make your life a little easier? Here you go.

  • If you're a solo entrepreneur with assets (house, car, etc.), consider changing your company’s designation from a solo proprietorship to an LLC or an S Corporation so that your personal assets are separated from your business ones, offering more protection for the former. 
  • If you are an LLC, consider filing your tax returns as an S Corp so that you can get some tax breaks. For instance, if you’re a shareholder of an LLC that files its taxes as an S Corporation, your distributions are not subject to employment tax.
  • If you have hefty quarterly payments and are struggling to pay them, consider asking for a payment installment plan that you can handle.
  • The IRS only goes back 3 years for tax audits. Keep your papers 5 years to be safe. Gone are the 7 years recommended in the past.
  • You need to open a business banking account if for no other reason than to make an audit run more smoothly. You don’t want an auditor wading through your personal affairs to locate your business interests.
  • If you travel anywhere with your vehicle for a business related purposes (networking event, conference, dinner, etc.), you can deduct the actual vehicle expenses or the standard rate per mile driven. For 2015 tax year, the standard rate is 57.5 cents per mile driven.
  • When you expense meals and entertainment, write down on the receipt who was in attendance as well as the purpose of the event. Your tax preparer will thank you!

Innovative New Concept for San Diego Life Science Startups

LabFellows recently announced the opening of Home Lab, an innovative approach to lab bench space for San Diego scientist entrepreneurs. Home Lab eliminates the burden of owning and running fully equipped labs by offering subscription-based packages. These packages pair lab bench space with pre-configured workflows (e.g. cell culture room, biosafety work areas), shared equipment and customized concierge-style services. This is an expansion of LabFellows’ ongoing commitment to provide ready-access resources for local science startups.

On a recent tour of the new facility, Julio de Unamuno IV, CEO, explained how Home Lab works: “A local start-up will first fill out a Request Guide which allows us to provide the best solution for that startup’s specific needs. Solutions range from hourly access to specific equipment to monthly subscriptions which includes wet lab space with modular workflow plans and on-site services. During the implementation phase, LabFellows outfits Home Lab with all the equipment, reagents and consumables your company needs, so the space will be turn-key and ready to start running experiments as soon as you step in!”.

LabFellows also helps with permitting, safety plans and other documentation needed to get you started. As a full-time or commuter user, LabFellows will provide a purchasing service, on-site shipping & delivery, waste disposal management, Wi-Fi, meeting rooms and 24/7 access with security.  

What separates Home Lab apart from incubators and co-working style facilities, is a new concierge approach that helps entrepreneurial scientists build their teams and conduct research in a configurable, efficient environment. LabFellows strives to eliminate the lab operation headaches that pull scientists away from the bench. It believes scientists should not be limited in their abilities to advance their research simply because they do not have access to the necessary workflows.

The LabFellows Management Team includes seasoned San Diego entrepreneurs: Julio de Unamuno IV (CEO and co-Founder of LabFellows) and Tim Ryan (COO and co-Founder LabFellows and San Diego Startup Week). To learn more about Home Lab, please visit sdee.labfellows.com and receive special rates for being a registered SDEE member!


Creating a Community to Help Student Entrepreneurs

Featured Interview with Regina Bernal, USC Entrepreneurship & Experiential Learning  

Regina Bernal leads entrepreneurship initiatives in the School of Business Administration at the University of San Diego (USD). As the entrepreneurship and experiential learning coordinator she empowers student entrepreneurs to turn their venture ideas into a reality through the V2 Pitch Competition, the Legacy Entrepreneurship Conference, and the year-long coaching and mentoring program.

“The goal of these initiatives is to help the next-generation of entrepreneurs go from an idea or inspiration to a venture concept, and maybe even launch their own business,” said Regina. “Regardless of the career path the students choose, they will learn the foundations of how to start up and move their ideas forward.” While the initiatives were born out of the School of Business Administration, they are open to students campus-wide—undergrad, MBA, and international.

What makes the initiatives unique is that they leverage the international theme of USD. “USD has had very close ties to Mexico, so we are initially focusing on the Cali-Baja mega region,” said Regina. With a USD track and a binational track, the initiatives provide resources for entrepreneurs on both sides of the border. Altogether the initiatives received more than 100 projects this year—55 for USD and 67 for binational. 

The highlight event each year is the V2 Pitch Competition, which has tripled in entrants, prize money, and attendees since its first run three years ago. “This is basically academia meets the real world,” said Regina. The students work directly with angel investors who look at business proposals on a day-to-day basis. “V2 has been a huge success on the extracurricular side. Members of the community come to network with the angel investors and meet the student ventures. It’s a huge celebration for entrepreneurship in San Diego,” said Regina. “Our first event had 15 entrants and now we’re up to 55. The ventures are very diverse and include technology, digital apps, devices, and lifestyle brands.”

The V2 Pitch Competition offers credibility that young entrepreneurs don’t typically have early on. “Winning students can say they are the best company coming out of USD, and that they have already received investment,” Regina explained. “One company took $40,000 out of a $50,000 fund. Investors are now interested to talk to them and willing to accept meetings.” V2 winners have gone to raise more than a million dollars. One is part of 500 Startups in San Francisco, a leading global venture capital seed fund and startup accelerator. “At the same time, it’s about the learning experience. We’ve identified successful companies through V2, but we’re just as concerned about the other companies. Our job as an academic institution is to be that educational port for entrepreneurship,” said Regina.

The program relies on input from different organizations in the community such as CONNECT, EvoNexus, and HeraHub. “People from the community are the main coaches and mentors for the students,” said Regina. Angel investors such as Analytic Ventures, Tech Coast Angels, and The Startup Garage are an important part of the initiatives, volunteering their time and expertise to review projects and pitch decks. While the events are free and open to the community, the initiatives depend on sponsorship to raise the money for the student prizes. For example, Startup Garage provides in-kind support for prize money. “Startup Garage offered $4,000 in prize money for a student entrepreneur, which is huge for us,” said Regina.

In preparation for the V2 competition the program provides workshops to help students build their pitch deck and design their business model. “Our professors lead a lot of the workshops, but we like to bring in people from the outside to share their expertise,” said Regina. They are plenty of opportunities for SDEE members to get involved. “If there are SDEE members that have product-to-market know-how, want to make themselves available to students, and be part of this millennial generation, I would be more than happy to make the connection,” said Regina. There are opportunities in the coaching and mentoring initiative, as a speaker for the entrepreneurship club, or as part of the deciding panel for the V2 Pitch Competition or the Legacy Entrepreneur Conference. “It’s beyond volunteering because you make connections to future entrepreneurs,” said Regina. “It’s magic when communities and academia come together. These amazing synergies benefit everyone involved.”

To learn more about the initiatives, please visit http://usdentrepreneurship.com/.


Seeking Mentors for CSUPERB Career Networking Session

Message from Susan Baxter, PhD, Executive Director, CSUPERB - 
 
The CSU Program for Education and Research in Biotechnology (CSUPERB) is hosting a Career Networking Session Friday afternoon (2:00 - 5:00pm), January 8th 2016, as part of the 28th CSU Biotechnology Symposium at the Hyatt Regency Orange County.

(1) Need to know more? Click on this link to read an FAQ and 

(2) What do you do if you're ready to sign-up? Please use this link to confirm you'll be there:  https://www.surveymonkey.com/r/5RZPJ3Z
(3) Can't participate this year? I'd greatly appreciate if you'd forward this email to colleagues, employees, friends and Cal State alumni you think may be interested. We usually end up filling this session by word-of-mouth and spreading the call for mentors through your networks!
If you have additional questions, don't hesitate to contact me!
 
THE DETAILS: 
Round table discussion topics roughly map to functional units of a typical life sciences organization - from discovery research to finance, from product development to intellectual property management, regulatory affairs to public health, etc. As always, we’re open to new discussion topics. 
Your participation helps CSU undergraduates and masters’ level student researchers explore career options at a relatively early stage in their careers, while also increasing your organization’s visibility to prospective employees. This is not a job fair. Based on survey responses, 100% of mentors responding participate because they think it is very important to “give back by discussing career paths and sharing personal experiences with students.” The session is part of the annual CSU Biotechnology Symposium (see evolving symposium program here): http://www.csuperb.org/symposium/)
Susan M. Baxter, Ph.D.
Executive Director
California State University
Program for Education and Research in Biotechnology (CSUPERB) 

 


How The CSU I-CORP Program Works – an interview with Dr. Susan Baxter

I recently talked with Susan Baxter, Ph.D., Executive Director of CSUPERB, to find out how the CSU I-Corps program is impacting the local biotech community.

“The CSU I-Corps program had 34 teams state-wide in the first year,” said Dr. Baxter. “We work with student-based teams in the fall and the faculty-led teams in the spring.” Each team has three members and works for three months to evolve a business model. “The student teams are made up of scientists and engineers, and are required to have a business student,” said Dr. Baxter. “The faculty teams include a faculty member, a post-doc or graduate student, or even an undergrad.”

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Want to learn how to bridge the entrepreneur - investor gap? Check out the Sept 19th Hera Venture Summit

SDEE partner, Hera Hub, presents Hera Venture Summit on Saturday September 19th to bring together EXPERTS from both sides of the investment table to share best practices, essential tips and lessons learned. Binational, local and global resources will be shared and discussed along with trends and hot topics around gender investing.

Please join us at this one-day intensive event aimed at equipping and connecting female founders and female funders. Register using our promo code SDEE40off to get a $40 discount. Stop by our SDEE exhibit table to see what resources we have for entrepreneurs. Hope to see you there!


Want to Help Academic Entrepreneurs Succeed? Check out Amy Duncan's interview with Susan Baxter, PhD, Executive Director CSUPERB.

Commercializing academic research isn’t typically included in the curriculum for scientific training. Entrepreneurial researchers struggle to translate their skills to industry and their inventions into a new company. Finding a market fit, or just navigating the entrepreneurial world can be a hard puzzle to solve. The skills required for success in a start-up differ from skills needed to succeed in an academic lab. 

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A Message From SDEE Executive Committee


Dear SDEE Members! Since our first roundtable in 2010, SDEE has been helping entrepreneurs and their companies succeed in San Diego. This would never have been possible without the extensive efforts and vision of our Founding President, Scott Thacher. After five years serving as our president, Scott asked the Board to choose a new president and I am honored to serve in that role for the next two years. Scott will continue to be actively involved in SDEE as a member of the Executive Committee and a member of our Board of Directors.

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ALT San Diego

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Alexandria

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Executive Managing Director
Global Life Sciences Practices Group

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Takeda San Diego Union Bank

SDEE BRONZE SPONSORS

Duane Morris MaxCyte Wagenknecht Barney and Barney Longfellow

SDEE is a nonprofit 501(c)(3) organization founded by local San Diego entrepreneurs
in order to provide a voice for the early stage start-up, to support new entrepreneurs and their companies,
and to sponsor networking and educational events
to help develop the skills necessary to bring funding, business, and jobs to the San Diego area.

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