Michael Skalsky, Ph.D. - Managing Director, Australia

Dr. Skalsky serves as Managing Director of Emergo Asia-Pacific Ltd., Emergo Group's office in Sydney, Australia. He brings many years of experience in the medical devices industry in Australia, helping companies to develop their products within quality systems as well as formulating market entry and business development programs. He has intimate knowledge of the medical technology product development and commercialization process having taken several device products from concept through clinical trials and regulatory approval.

Mike also serves as the primary liaison between Emergo's Sponsor representation clients and the Therapeutic Goods Administration (TGA) in Canberra. He is frequently in contact with the TGA and often assists Emergo clients with regulatory, quality assurance, classification and registration issues.

EXPERIENCE:

Managing Director, Sci2Rx Pty. Ltd. (2003-2008)

• Strategic market analysis and market research for a number of technology products in a range of application fields (including running focus groups with clinicians both in Australia and USA).
• Business partnering.
  
• Due diligence for M&A on behalf of VC's and listed companies.
• Strategic review of research programs of several publicly funded organizations and partnering them with industry.
• Product development risk analysis and manufacturing process trouble shooting.
• Review and advice on regulatory strategy; review of design history and technical files.
• IP portfolio analysis and expert advice for patent opposition and litigation.
• Grant application development.
• Business planning and strategy development.
• Interim CEO/Project Manager for several early stage client companies.
• Strategic analysis and structuring of a IP commercialisation vehicle for a major teaching hospital group.

Managing Director, AorTech Biomaterials Pty. Ltd. (2000-2002)

• Development of strategy and business development plans.
• Recruiting and leading the management team across sites in Sydney and Melbourne to meet business objectives.
• International business development and marketing, international trade show participation, brand development- with particular focus on the USA.
• Client account management.
• Quality assurance to meet ISO 9001 accreditation requirements/risk management.
• Investor relations with venture capital, analysts and government departments.
• Negotiation of licensing agreements and management of associated legal issues.
• IP portfolio management.
• Financial reporting, auditing and disclosures as required of a UK listed public company

Founder and Managing Director, Elastomedic Pty. Ltd. (1997-2000)

• Developed business plan for commercial development of a new biomaterial.
• Negotiated licence and shareholder agreements.
• Secured seed and venture capital.
• Secured major government grant ($ 2.5 M over 3 years).
• Established facilities and recruited the team.
• Managed international business development.
• Secured several licensing deals with international device companies.
• Built a global product brand (Elast-Eon).
• Negotiated and executed the trade sale of the company.

Scientist, Engineer and Program Leader, Telectronics Pacing Systems (1978-1997)

• Managed major international implantable heart pacemaker projects within the company.
• Led a team of scientists toward achievement of research goals.
• Strategic and business planning for a range of projects.
• Took projects from research stage through to market launch.
• Set up of pre-clinical studies and clinical trials/compliance with regulatory requirements (eg GLP systems).
• Developed and managed research alliances with external providers.
• Oversight of technical publications and intellectual property disclosures.
• Developed contracts and agreements with external organisations
• Coordinated multiple research and development projects.

AFFILIATIONS:

• Member, NSW Branch Committee of AusMedtech

EDUCATION:

• Bachelor degree in Chemical Engineering, University of New South Wales
• Masters of Business Administration, University of New South Wales
• Ph.D. in Chemical/Biomedical Engineering, University of New South Wales

HOME BASE:

• Sydney, NSW, Australia