Prior projects

Some prior projects

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

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

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)

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 U.S.markets

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.

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

Market analysis and reimbursement analysis for innovative invitro diagnostics (IVD)
Guidance for European surgical system in engaging with U.S. federal R&D programs and research institution for prototyping. Support in complying with formalities for registrations, pre-application, and submission documents
Identification and engagement with European KOL sites for clinical testing of U.S. drug delivery device

Feasibility study for U.S. cardiology devices on rationale, identification of potential third parties and of value drivers for a strategic partnership.
Identification of distributors for a life-support medical device system, in Indonesia.
Guidance and preparation of the local registration for a life-support medical device system, to the Ministry of Health in Indonesia.