3 min reading time

Meddevice CEO Rhonda Rhyne was going to be a doctor.

Instead, she attended pharmacy school and by age 31, Rhonda led biotech company Culture Technology.

By 36, she was president at CardioDynamics where she raised $30 million in financing, and later sold the company to Sonosite in 2009 at a 69-percent premium.

Read her “Keys to the Corner Office: Success Strategies for Women by Women” at Amazon http://medgroup.biz/amzn-rhyne

Her counsel for medical device company leaders?
> Raise more money than you estimate you’ll need.

I asked, “Why would an investor give you more than you need? Many group members struggle getting 1x what they need.”

“You almost invariably need more money than you’ve projected… especially if you’re doing clinical trials,” and continued, “I don’t lose credibility if I raised too much… but I do if I have to ask for more.”

Rhonda’s company Prevencio is developing a blood test to detect obstructive coronary artery disease. Widespread adoption of the test would eliminate unnecessary trips to the cath lab. (She estimates 20 to 50 percent of all catherizations are wasteful.)

She taught me more in our hour-long lunch than I can relay here. Would you like to meet her in person?

Rhonda will open our 3rd-annual 10x Medical Device Conference (May, San Diego) as our keynote speaker.

See http://medgroup.biz/Meet-Rhonda for details. Come for her keynote, the opening reception, and Manufacturers Showcase – even if you can’t stay for the whole conference.

Do you agree with Rhonda’s advice?

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10x speaker lineup at http://medgroup.biz/10x-speakers

32 speakers including:
• Rhonda Rhyne, CEO, Prevencio
• Rick Baron, CFO, Globus Medical
• FDA speaker to be announced
• Bill Floyd, CEO, CSA Medical
• Dr. Peter Havel, TÜV SÜD America
• Sanjeev Saxena, CEO, POC Medical
• Howard Luks, MD, Orthopedic Surgeon
• Eric Knudsen, Director, ZOLL Medical
• Raymond McCauley, Principal, Exponential Biosciences
• Rob Packard, CEO, Medical Device Academy
• Mike Sperduti, Principal, Emerge Sales
• Sean Schantzen, COO, Healthfundr

Full agenda at http://medgroup.biz/10x-agenda

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CALL FOR MEDDEV MANUFACTURERS

The 10x Manufacturers Showcase will feature your medical devices immediately following Rhonda’s keynote speech, during the 2-hour welcome reception.

Each guest will “vote” for the best medical device. The manufacturer with the most votes “wins” and will get to present on-stage on May 6 for 20 minutes (10 min to present; 10 for questions). The session will be recorded and professionally edited.

Would that be of interest for you? See http://www.medgroup.biz/10x-showcase

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. If you are price-sensitive, register for 10x by October 31 for the lowest price. And if you need to cancel for any reason before February 28, I’ll refund you 100% (no transaction fees). Sound good? http://medicaldeviceevents.com/conference-registration/

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Dennis King
President and CEO, STATKING Clinical Services
Her point about clinical trial costs is a good one. CEOs should consult with CROs and get bids for studies BEFORE trying to raise funds. CEOs need to realize that they will have to pay the CRO to manage the trial and the sites to conduct the trial.

Joe Camaratta
General Manager at MedAvante-ProPhase
In my experience, medical technology companies grossly underestimated the information that they need to collect and provide to effectively commercialize a new technology. They use 510(k) clearance as an endpoint for their clinical trials and are not adequately prepared to address the new requirements of clinical efficacy and cost effectiveness need to support market adoption.

Richard M. Satava
Professor Emeritus of Surgery at Univ Washington – Seattle
Rhonda’s perspective is excellent. In 12years of funding research for the government at DARPA, it was patently clear that few if any of the non-industry (academic) researchers (and probably many of the industry-based researchers) significantly underestimated their needs for tech transfer (including clinical trials) and commercialization. Research up to the final ‘shrink wrap prototype’ (Technology Readiness Level (TRL) 5) for FDA approval constitutes about 10% of the full cost of the entire research effort (that results in a product). While there is the balance between asking for what funding the researcher thinks they can get and how much it will realistically cost is tricky. This is where an experienced researcher (serial entrepreneur) is of great value.

Claudia Campbell-Matland
Consultant – Medical Devices & IVDs
Rhonda’s points are well taken. In today’s increasingly conservative regulatory landscape, companies need to thoroughly understand all applicable standards & regulations. While you will want assume best or nominal case scenarios for schedule purposes, you also need to have contingency plans & financing ready to address additional requirements that may be requested by FDA or other regulatory bodies.

Dan Richmond
Consulting Manager at DRC Healthcare Consulting
Always a good read thanks for posting Joe.

Fernando Priego Figueroa
Profesional independiente en el sector Medicina práctica
I would like to get registered. How do I do this proccess ?

David Lim
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
It needs to be reasonably assessed based on actionable/doable milestones in view of inventions, nature of technology, teams, market/future prospects, etc.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Fernando, we’ll delight in having you.

You can register at [http://medicaldeviceevents.com/conference-registration/|leo://plh/http%3A*3*3medicaldeviceevents%2Ecom*3conference-registration*3/FXzv?_t=tracking_disc]

And all are welcome to email me at JHage@MedicalDevicesGroup.net for a copy of the brochure and guest list.