John Ashley Email & Phone Number

Cofounded this innovative motion preserving scoliosis technology company in 2017. Took over as CEO in 2023. Product was named the 2020 Spine Technology of the Year by Orthopedics this Week and was granted FDA Breakthrough Device Designation.

San Francisco, Ca, Us

Brookfield, Ct, Us

Provide Business strategy to the CEO and Co-founder of this telehealth company that has commercialized innovative technology for lower extremity and cardiac rehabilitation.

Member of the Bioengineering Industry Advisory Board. Mentor for Bioengineering Senior Project Teams. Guest lecturer.

Assist UCSF medical device innovators with product development, business strategy, and commercialization. Guest Lecturer.

Co-founded spin out from MGH. Negotiated IP license, developed business plans and presentations, managed product development and bench & pre-clinical testing, drove fund raising ($6M), and engaged KOLs.

Co-founded company with cardio-thoracic surgeon to develop next generation tools for percutaneous valve replacement. Secured multiple non-dilutive grants. Expanded IP portfolio. Hired and managed product development team. Berkeley SkyDeck Hotdesk company for Spring 2018.

Palo Alto, California, Us

Provide diligence and deal flow to Hunniwell Lakes medical device investment activities. Active management of and advise to select portfolio companies. Leverage domain expertise in R&D, Operations, Regulatory, and Engineering to drive value across spectrum of partnership initiatives. Represent Hunniwell Lake at conferences and on panels. Provide mentoring and specific area expertise to interns.

Provide leadership, strategic planning, fundraising, and product development management for early-stage start-up in Point of Care diagnostic market.

I was recruited into this emerging start-up to drive the development and commercialization of a novel UVC technology for point of care sterilization for the reduction of systemic infections. Impact highlights included…• Completed the engineering and testing of initial product for first-in-human usability study.• Submitted company's 1st 510(k) submission and managed FDA communications to secure product clearance. • Served as the Management Representative - setup and managed Quality system which resulted in ISO13485 certification.• Initiated new point of care UVC disinfection project including set-up of 3 separate design/development contracts, lead multiple clinical advisor and user group feedback sessions, managed in-house micro-bio lab set-up and product testing.• Presented company's innovative technology to multiple potential strategic partners for licensing opportunities.

After the successful experience at Co-Align, I established this boutique consulting business to provide leadership, strategic planning, fundraising, and business development analysis, recommendations and implementation for early stage startups in medical device, diagnostic and digital health markets. Engagement highlights include… .• Providing strategy, business planning, and fundraising for Ion Dx, a start-up out of Lawrence Livermore National Lab with Breakout Lab funding and a novel ion mobility spectrometer. • Assisting in post-acquisition regulatory, R&D, and quality system integration between CoAlign Innovations and Stryker. Provided guidance on management process and personnel issues. Collaborated on engineering design and manufacturing solutions.• Mentoring multiple startup digital health companies on behalf of collaboration between MIT and Carnegie Mellon; analyze market potential, recommend strategy, facilitate industry connections, and provide overall business guidance.• Driving financing to secure a Term Sheet and leading product development and testing efforts for mitral valve repair start-up

I was promoted by this manufacturer and marketer of expandable spinal fusion products to provide operational leadership as the company transitioned from product development into manufacturing, commercialization and distribution, while continuing to lead R&D to support rapid growth. This entailed recruiting and leading the manufacturing and quality teams, as well as designing and implementing operational infrastructure, including the quality system. Additionally, I planned production facilities and sourced all resources, oversaw all ongoing production, collaborated with surgeon advisors on initial clinical cases as well as distributors. Finally, I drafted regulatory filings & responses for 510(k), presented technology to industry, and participated extensively in acquisition due diligence with Stryker.Impact highlights included…• Ramped production from zero to well into the millions of dollars.• Built a complete state of the art controlled environment room and laser welding capability.• Achieved eleven 510(k) clearances.• Completed multiple FDA, ISO and related quality audits with no major findings.• Increased company and technology recognition, leading to sale to Stryker Spine at exceptional multiples.

I was recruited shortly after the company completed its series A funding as a member of the senior leadership team to manage the development and commercialization of a novel expandable interbody fusion cage, the company’s primary product. I recruited and led R&D and quality teams, and selected and led development, quality and regulatory consultants, as well as oversaw the IP portfolio including outside counsel. I reported to board and presented technology to KOL’s, as well as drove design and development encompassing CAD, fabrication, vendor selection and testing, and surgeon feedback.Impact highlights included…• Drafted, filed nine patents, and met with U.S. patent examiner to accelerate patent approvals.• Received FDA approval to market the product.• Completed close to 100 clinical cases, setting the groundwork for successful product launch.

I was recruited to oversee an R&D team of full-time and consulting engineers/technicians as this series A medical device company that was focused on transdermal energy delivery for aesthetic skin tightening was developing a disposable hand piece and power console for plastic surgery centers. I co-wrote the company’s first 510(k) filing and all IRB filings and correspondence, lead regulatory, clinical and quality functions, managed the IP portfolio, developed licensing strategy, and oversaw three outside attorneys.Impact highlights included...• Released software and completed hardware testing for human clinical cases.• Received FDA marketing clearance and IRB approvals.• Developed and implemented a new quality system, resulting in California FDB approval.• Filed four patent applications.

Brought in as president and CEO to lead strategy for technologies and products for knotless securing of sutures. Secured four rounds of financing. Drove product development, IP portfolio licensing and organic expansion.  Wrote and presented business plan/pitch to investor forums and VCs. Raised 4 separate angel rounds of debt. Retained R&D consultants and met with general, gynecology, urology, orthopedic and oncology surgeons to develop a broad scientific advisory board. Analyzed licensed patents and competitive field to determine design pathway. Negotiated agreement for core technology in third party’s heart implant, leading to first clinical human cases.  Completed 12 animal studies with associated publication in leading medical journal of bench and animal test results. Granted eight patents for three distinct technology platforms.

This was my first stint as a consultant, based on my success in prior corporate roles. I provided leadership, strategic planning, fundraising and business development analysis, recommendations and implementation for early stage medical device and venture capital groups in healthcare markets. Engagement highlights included…  Provided business development strategy and implementation for Sutter Hill Ventures for new energy delivery modality for collagen modification in sports medicine market.• Delivered detailed cost of goods analysis for both disposable hand piece and hardware console; Crafted three and five year financials. Advised sole practitioner doctor on entire product development strategy and methodology for a minimally invasive spinal stenosis medical device. • Hired and managed team of 16 employees; Completed first human clinical study; Achieved FDA product approval.

I launched this orthopedic startup to develop products in sports medicine market starting with a knot-less bone anchor for rotator cuff repair implant. I compiled and analyzed competitive patents to determine design pathway for Series A funding, drafted patent disclosures and drawings and contributed expanded claims to multiple patent applications, and designed, prototyped, and tested proof of concept models.Impact highlights included…• Secured FDA clearance.• Company sold for 8x return 20 months after single financing.

Medical device company specializing in atherectomy catheters.

Medical device company specializing in energy delivery products for the sports medicine and spinal markets. Promoted twice during tenure as company grew from 5 to 155 employees. Worked for S&N for 4 months after acquisition closed.

Abbott Park, Illinois, Us

M.S., Engineering

B.S., Mechanical Engineering