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Medical Device R&D management

Location:
Sunnyvale, CA, 94022
Posted:
August 15, 2012

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Resume:

*** ******** ****

Los Altos CA *****

650-***-**** (home), 650-***-**** (cell)

email: go23mt@r.postjobfree.com

Blog on R&D: http://steveaxelrod.wordpress.com/

Steve Axelrod, Ph. D.

Professional Summary

• R&D executive with proven ability to develop and deliver complex products to market.

• Experienced in bringing focus to cross-disciplinary teams engaging in multiple projects by the use of processes customized to the people and tasks at hand.

• Innovative scientist/engineer, with 17 patents/applications and numerous conference publications on novel concepts, algorithms and techniques.

• Possesses a clear understanding of how science and technology merge with market requirements to create successful products in both FDA regulated and industrial business segments.

Selected Accomplishments

• Created complete business plans for medical device startup companies in the areas of gastrointestinal testing, X-ray diagnostics, and medical imaging software.

• Key contributor in developing and perfecting the Axxent miniature X-ray source medical device, a breakthrough modality for brachytherapy radiation treatment, including all characterization and manufacturing testing apparatus and techniques

• Developed, or led development of, over 10 major industrial sensor products, including sophisticated on-line measurement devices employing nuclear, X-ray, electromagnetic, infrared, laser-based and visible optical technologies.

Work Experience

11/2011 – Present

CEO, G-Tech Medical

Oversaw all activities of the seed stage startup. Led team of over 20 part time staff in creating a business plan, including a product roadmap harmonized with the clinical need, market opportunities and regulatory and reimbursement realities. Focused clinical discussions via White Papers and physician questionnaires. Created R&D Project Plan and Financial Plan covering all corporate activities from first funding to manufacturing transfer. Led ongoing fundamental research and product engineering efforts for first prototype.

6/1/2010 – 11/2011

Consultant, multiple medical device startup companies, e.g.

• RefleXion Medical – created 3 year, $10MM project plan to develop prototype radiation therapy device consisting of a TomoTherapy-like delivery component combined with a real time PET system to identify tumor volume rapidly enough to track breathing based motion. Plan is built from ~ 600 individual tasks spanning disciplines of physics, mechanical, electrical and software engineering, with contributions from QA, RA, and Clinical groups.

• TomoSoft – Performed technical analysis of innovative new Fourier based algorithm for CT reconstruction at lower dose, assessed opportunity vs. competitive offerings, crafted strategy an developed project plan to create prototype standalone software product for retrofit market.

• Oraya Therapeutic – developed LabVIEW based laboratory measurement system for exploration of physics characteristics of their 100 kV X-ray delivery system for treating macular degeneration.

2/2010 – 6/2010, Solta Medical, Hayward, CA

Vice President, Research, Development and Engineering

• Was brought in to merge two separate R&D organizations formed from the merger of Thermage and Reliant Corps, a combined group of ~35 scientists, optical, mechanical, electronic and software engineers with an annual budget of $12M. Left when company embarked on an outsourced R&D model.

• Instituted multiple new processes that established and communicated priorities, improved focus on high value tasks and accomplishments, and upgraded quality and documentation of technical studies.

12/03 – 6/09, Xoft, Inc., Sunnyvale, CA

Senior Director, Applied Research and Co-chair, Office of Advanced Technology and Science

Designed, implemented, or led substantially all the radiation characterization measurements, including novel new approaches for this company’s flagship product Axxent miniature X-ray source used to treat cancer.

• Managed several large projects to completion through formal Design Control phases, including generation of Hazard Analysis, FMEA, and Error Budget documents.

• Headed development of techniques and systems for revealing the physics behind the X-ray source’s operation, supporting improved performance and substantial increases in manufacturing yield. Created the manufacturing test procedures, and led the team developing the hardware and software.

6/88–12/03, Honeywell/Measurex and Measurex Corp., Cupertino, CA

Director, Sensor and HW Engineering, Paper and Industrial Systems Divisions (4/00 – 12/03); Positions of increasing responsibility, from Senior Physicist through Director of HW R&D for the Industrial Systems Division (6/88 – 4/00)

• Leader of the R&D team that represented the most important core capability of the former Measurex Corporation, a $400M annual business at the time of purchase by Honeywell.

• Managed cross functional teams of 30 scientists, mechanical and electronic engineers engaged in the development and support of highly sophisticated sensors, precision scanning devices and data acquisition/process control systems.

• Initiated effective multi-function team based development processes. Created and maintained a 5 year product roadmap of an integrated product line, with substantial component reuse, which improved new product output and quality.

• Established standard procedures for fully characterizing performance characteristics of new products as a means of improving performance, and as a means of supporting marketing efforts to leverage the resulting competitive performance advantages.

Education & Academic Experience

6/85–6/88 Post-Doctoral Research Associate, High Energy Physics, Stanford University, Department of Physics, Palo Alto, CA

1985 Ph. D., Experimental High Energy Physics, Yale University, New Haven, CT

1976 Bachelor of Science with Honors in Physics, Magna Cum Laude; Phi Beta Kappa, Phi Kappa Phi, University of Connecticut, Storrs, CT

Memberships

American Association of Physicists in Medicine (AAPM), American Physical Society (APS)________________________________________

Publications, Patents and Awards

Nine granted, and eight pending patents:

201******** Radiation sensor arrays for use with brachytherapy

201******** Treatment of lesions or imperfections in skin, near-skin or in other anatomic tissues, including under direct visualization

201******** Applicators for brachytherapy treatment

200******** Proportional attenuation of radiation in brachytherapy treatment

200******** Method and apparatus for modifying distance from a brachytherapy radiation source to sensitive anatomical structures

200******** Brachytherapy apparatus and method using off-center radiation source

200******** Treatment of lesions or imperfections in mammalian skin or near-skin tissues or in or near other anatomic surfaces

200******** Lightweight radiation absorbing shield

• 7,771,340 Method and apparatus for modifying distance from a brachytherapy radiation source to sensitive anatomical structures

• 7,088,456 Thin film thickness measurement using multichannel infrared sensor

• 6,967,726 Means for in-place automated calibration of optically-based thickness sensor

• 6,961,126 Optical wavelength splitter

• 6,936,137 Air clamp stabilizer for continuous web materials

• 6,920,030 Apparatus for eliminating static electrical charges from a web of dielectric sheet material

• 5,714,763 Method and apparatus for optical alignment of a measuring head in an X-Y plane

• 5,432,353 Nuclear gauge

• 5,315,124 Nuclear gauge

Papers, Conference Presentations and Posters (since 2006):

• Author or co-author of over 25 peer-reviewed conference oral papers and posters, one article published in “Medical Physics”, and invited speaker at three medically related conferences:

• M. Rivard et al, “Calculated and measured brachytherapy dosimetry parameters for the Xoft AXXENT X-ray source: An electronic brachytherapy source” Medical Physics Volume 33, Issue 11, pp. 3979-4450

• Invited speaker at the following meetings:

• Sacramento Area Mammography Society (2009) annual meeting

• Amer. Assoc. of Medical Dosimetrists (2008) annual meeting

• Health Physics Society (2008) regional annual meeting

• “Master of Ceremonies” at Xoft sponsored breakfast at ACRO 2006

• Primary author or initiator of the following Conference Oral Presentations or Posters:

• S. Axelrod et al, “Dosimetry of a Family of eBx Surface Applicators from 10 to 50 mm Diameter” presented at the American Association of Physicists in Medicine (AAPM) meeting, (July 2009)

• L. Kelley and S. Axelrod, “Calibration of Type EBT Radiochromic Film at 50 kVp and Sensitivity to Spectral Hardening” presented at the American Association of Physicists in Medicine (AAPM) meeting, (July 2009)

• S. Axelrod, Tai Ngo and Thomas Rusch, “Novel Technique for Quantifying Balloon Shape” Presented at the American Brachytherapy Society (ABS) Annual meeting, (May 2009)

• S. Axelrod et al, “Dosimetry of a New Electronic Brachytherapy Surface Applicator” Presented at the American Brachytherapy Society (ABS) Annual meeting, (May 2009)

• S. Axelrod, M. Carol, “Comparison of Heart Dose of eBx and Multi-channel HDR Breast Applicators” Presented at the American Brachytherapy Society (ABS) Annual meeting, (May 2009)

• S. Axelrod et al, “Theoretical and Benchtop Study of a Novel Means of Skin Sparing By Sculpting Dose With the Xoft Axxent Source” Oral Presentation at the American Brachytherapy Society (ABS) Annual meeting, (2008)

• S. Axelrod et al, “An enabling technology for creating sculpted brachytherapy dose patterns with the Xoft Axxent™ system” Oral Presentation at the American Association of Physicists in Medicine (AAPM) meeting, (2008)

• S. Axelrod et al, “Film based treatment plan validation for a new vaginal applicator using the Xoft Axxent™ 50 kVp miniature X-ray source” Presented at the American Association of Physicists in Medicine (AAPM) meeting, (2008)

• S. Axelrod et al, “Theoretical and Benchtop Study of a Novel Means of Skin Sparing By Sculpting Dose With the Xoft Axxent Source” Oral Presentation at the American Brachytherapy Society (ABS) Annual meeting, (2008)

• S. Axelrod et al, “Isodose Contours and Depth-Dose Behavior of Multi-Catheter Breast Applicators” Presented at the American Brachytherapy Society (ABS) Annual meeting, (2008)

• S. Axelrod et al, “Ray Traces and Pinhole Images of the Xoft Axxent™ X-ray Source” Oral Presentation at the American Association of Physicists in Medicine (AAPM) meeting, (2007)

• S. Axelrod, T.W. Rusch, M. Powell, Xoft Routine Per Article Manufacturing Testing of the Axxent Source, Presented at the American Association of Physicists in Medicine (AAPM) meeting, (2007)

• S. Axelrod, T. Rusch, “Characterization of MOSFET Response to the Xoft Axxent X-ray Brachytherapy Source,” Presented at the American Association of Physicists in Medicine (AAPM) meeting, (2006)

• S. Axelrod, “Volumetric Analysis of Dose Delivered by Xoft Axxent X-ray Sources,” Presented at the American Association of Physicists in Medicine (AAPM) meeting, (2006)

• S. Axelrod, T. Rusch, "Treatment Plan Validation of the Xoft Axxent X-ray Source," Oral Presentation at the American Association of Physicists in Medicine (AAPM) meeting, (2005)

Numerous awards from Measurex and Honeywell for delivering exceptional products and projects



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