Management Team

Michael Kleine

President & Chief Executive Officer

Mike is an established leader with a proven track record of success in leading several global biomedical companies.  With nearly two decades of experience in C-suite positions he has experience commercializing new technologies, increasing revenues, and growing organizations. Previous positions held include President and CEO roles with EndoGastric Solutions, Biosensors International Group, LTD, a publicly traded company, and MicroVention, a start-up which was acquired by Terumo.  Mike will continue to serve as the Chairman of the Board for EndoGastric Solutions.

Steve Kim

Chief Technology Officer

Co-founder of Miramar Labs and driven innovator with nearly 100 issued patents and 18 years experience in start-up medical device companies, including AnueRx (acquired by Medtronic), TransVascular (acquired by Medtronic), Vivant Medical (acquired by Tyco Healthcare), and Vibrynt, where he’s held various R&D and general management positions. Steve has significant experience in developing implants, catheters, surgical tools, and microwave ablation devices.

Brigid A. Makes

Sr. Vice President and Chief Financial Officer

Successful financial executive with over 30 years of experience in leading and building strong organizations, and delivering results. Experience with IPOs and M&A in high growth and technology focused businesses including large and small companies. Successfully transitioned AGA Medical through its IPO process and acquisition by St Jude Medical. Served in executive roles in finance, operations and R&D at Nektar Therapeutics, and in senior financial roles in Haemonetics, Lotus Development and GE.

Kathy O’Shaughnessy, Ph.D.

Vice President, Clinical, Regulatory & QA

Successful leader of clinical, regulatory and quality assurance efforts over the past sixteen years at medical device companies, such as R2 Technology, Xoft and Allux Medical. Kathy has significant experience guiding both 510(k) and PMA devices through the Regulatory process (US and International) and has led major clinical studies from conceptual phase to completion.

Rob Ellis

Vice President, Marketing

Rob brings over 20 years of experience in healthcare sales and marketing, with a focus in the last 12 years of building and leading global marketing teams with aesthetic device companies including Solta, Sciton, and Lumenis.  His leadership has driven many successful global product launches in dermatology and plastic surgery.  Rob’s programs have captured the attention of physicians and patients through national exposure on The Today Show, Entertainment Tonight, The Doctors, People and Glamour magazine and he has been recognized with the Silver SABRE award for Public Relations.  Rob holds a BS in Biochemistry/Biophysics and an MBA.


Bernard Shay

Vice President, Law and General Counsel

Veteran medical technology expert with over 25 years of experience with M&A, litigation, licensing, intellectual property, compliance, business development and engineering at a range of leading companies, including Johnson & Johnson, General Electric and IBM.


James Lam

Managing Director, Asia Pacific

Successful leader in the medical device industry with over 33 years of sales, marketing and general management experience in Asia Pacific , extensively in China. James possesses a proven track record managing  sales and marketing operations that exceed $120 million and a reputation for driving sales excellence. Prior companies include Siemens AG, Stryker, Sherwood DG, Boston Scientific, AGA Medical and St. Jude Medical.

Steve Higa

Vice President, Manufacturing

Proven leader with over seventeen years of experience leading operations, manufacturing, and product development teams in the medical device industry. With a reputation of fostering a culture of continuous improvement, Steve has successfully managed operations growth to support company revenue and sales goals. Prior companies include ZOLL Medical, Amira Medical (acquired by Roche), and Johnson & Johnson.