Home / Prior-projects

Some prior projects (1)

  • Analysis of European market metrics for U.S. glaucoma ophthalmology devices, with CE-marking as well as reimbursement analysis & strategy formulation
  • Analysis with recommendation for location of European distribution center for U.S. cardiac device business, based on alternative locations’ factor costs matched with qualitative assessment of ease of doing business
  • European ophthalmology devices – funding Euro 2 million 50% “soft” loan and 50% venture capital. Marketing and Sales Support towards selected export markets
  • Business plan with investor term sheet for new European aesthetic medicine and plastic surgery clinic
  • Market launch of U.S. implantable ophthalmology device in EU markets

Some prior projects (2)

  • Market analysis for PEMF Pulsed Electromagnetic Field Therapy device in European market; for identification of in-licensing opportunities of Active Pharmaceutical Ingredients internationally and respectively market & data analysis for non-invasive diagnostic device across Europe, USA and China
  • European contractor & Ministry Economic Affairs Netherlands – analysis and selection of projects in the local medtech sector in cooperation with Regional Development Agencies for commercial development support: Introduction of bio-pharma formulation for laboratory testing and validation towards U.S. Federal Agencies, commercialization of advanced contract-manufacturer services towards Nordic and U.S. medtech markets and of a robotic assist device towards international markets
  • European Biotechnology business – funding Euro 1.2 million 50% “soft” loan and 50% venture capital. Marketing and Sales Support towards selected export markets

Some prior projects (3)

  • U.S. Vascular device business – European contract-manufacturing plus regulatory clearance support, with USD 0.5 million upfront non-diluting funding. Presented in U.S. new Chief Executive Officer to company. Also aligned U.S. venture capital for new USD 1.5 million funding round
  • Organized contract-development of a field “NanoReader” for biological samples to serve with a U.S. firm’s lab-on-a-chip, for an ad-hoc industry consortia we established between the Netherlands and Denmark; secured upfront free cash of Euro 0.3 million to enable the project
  • US ophthalmology device – European animal validation, human trials, design development, regulatory EU & US, contract-manufacturing, with EU distribution option, supported by Euro 1.7 million funding package (non-diluting)

Some prior projects (4)

  • Innovative derma-spray formulation – Operational support to the European licensor in the identification, connection and establishment of agreement with a local distributor for the Italian pharmacy sector
  • New export development internationally – Operational support in cooperation with one of the Regional Development Agencies in The Netherlands for medical device companies, in entering new markets in Europe, North America and Gulf States
  • New export development to the USA – Operational support in cooperation with a “Fortune 100” group, to half a dozen European medical device companies, in entering the

Some prior projects (5)

  • FDA regulatory approval for European implantable prosthesis: classification, time-line with budget, predicate devices, document template, guidance
  • FDA regulatory approval for U.S. wound care formulations: classifications possible, time-line with budget, document templates, guidance
  • Commercialization support for U.S.CRO’s analytical services to EU pharamceutical firms
  • Sales prospecting for European laboratory equipment towards cell samples R&D facilities
  • Identification and engagement with European KOL sites for clinical testing of U.S. drug delivery device

Some prior projects (6)

  • Business Plan and financials for European clinical trials software, connected IT consultant and QMS advisor.
  • Guidance on project organization, plus introduced PI, subject matter industry expert and reviewer (retired) for preparation of SBIR submission, for U.S. cardiology device project.
  • Prospecting listing, connections to distributors internationally with business support, for European firm’s volatile compounds analysis system.