I provide engineering and management consulting services for medical technology companies located in the Nordics, EU, and US. I understand how to practically get things done and work hands-on in collaboration with the client's team to accomplish company goals.I have over 25 years of medical device industry experience across many domains, which has helped me build expertise encompassing project & program management, quality system, supply chain, process development, test method development, and mechanical design work.I can help bridge communication and culture between Academia and Industry, US and EU, and startup and large org.I specialize in giving practical, actionable advice and services to small med-tech startup companies.

VentriLabs is a Biotech and Medtech company developing solutions within liquid flow control and fluid transfer for gentle transfer of delicate fluids with high precision, exerting minimal damaging stress to preserve the integrity of even the most fragile substances. VentriLabs excels across a multitude of applications, ranging from rigorous bioprocess operations to critical clinical systems utilizing extracorporeal blood circulation.

Our mission is to improve patient care by applying neurostimulation methods to orthopedics. We are creating active orthopedic implantables to provide patients with faster and better healing and provide physicians with real-time patient data.Responsible for Product Development and Quality organizationsSelected & Implemented Quality SystemSelected & Implemented eQMSVendor identification and selection & developmentHands-on design, prototyping, testing & test developmentIn addition to typical VP responsibilities, the small startup environment here has enabled me to exercise and polish my design and fabrication skills. I have improved my Solidworks, Python, hardware & PCB design skills to contribute to the implant, manufacturing process, and testing capabilities. I designed, built, programmed and tested compression & shear cyclic fatigue test equipment based on ASTM F2077 for R&D prototype testing. I also designed and built electromechanical test fixtures for in-process product testing.In addition to implant and test development, I have spent time directly building operations and quality. I created travelers & manufacturing processes and managed document control.

Hands-on management of Xeltis operations and facilities & electrospinning equipmentGuiding systems, organization, facilities and processes from small scale electrospun implant manufacturing towards industrializationMRP system identification and implementation

Responsible for electrospinning R&D, electrospinning process development, operations, physical test team, and facilitiesManaged development of aortic valve delivery systemManaged a diverse, multinational scientific and engineering team

-Managed next generation sinuplasty balloon system development including mechanical and electronic systems-Authored and promoted business case to support program selection-Aggregation and analysis of CMS, hospital useage, and reimbursement data-Field support, system installation, and Physician and staff training

-Responsible for Cyclone program from ideation through commercial market launch-Lead other internal R&D programs developing electromechanical devices from ideation through early development stages-Spearheaded adding digital fabrication capabilities to Entellus including FDM, SLA and rapid injection molding-Project Management-Product conceptualization-Rapid prototyping-Device and component design-Design for Manufacturing-Product Spec author-Voice of customer-Test method development-Field support, system installation, and training

Responsible for Transcatheter Mitral Valve Replacement (TMVR) delivery system development-delivery system project management-product design-prototyping-test model development-bench & pre-clinical testingInitiated digital prototyping capabilities:-spearheaded adding digital fabrication capabilities to Caisson for prototype and anatomical model fabrication-reviewed, selected and purchased FDM 3D printing equipment-reviewed, selected and purchased small scale injection molding equipment

Sucessfully led development of dual lumen power injectable PICC catheter and SecurAcath catheter securement system both containing innovative new catheter securement technology utilizing NITINOL anchors from concept through development, animal testing, design verification, manufacturing setup, submission to FDA, and commercialization.• Led new team to successfully recover 1st generation PICC catheter securement technology project from earlier development effort by previous development team. Product now has FDA clearance and completed clinical study. Multiple iterations of this device were developed and cleared through the FDA. • Led development effort on multiple iterations of the “SecurAcath” product platform from concept through FDA submission, initial human use, and commercialization. • Led strategic planning effort to select R&D, regulatory, and manufacturing strategy• Performed market analysis to create product line extension strategy• Co-develped marketing specifications• Closely worked with executive management team and investors to match product and project performance with investor expectations• Created documents and communication tools to assist CEO and CMO’s communication with company board• Collaborated with founding physician and other users to develop device requirements• Developed product specifications• Co-developed manufacturing processes and systems• Designed high volume injection molded, overmolded and extruded components• Prototyped devices for concept selection and testing• Invented novel method of prototyping injection molded components• Designed and constructed test methods and equipment• Selected manufacturing outsourcing vendors• Selected component suppliers• Selected company IT services provider• Assisted with design and layout of new company facility• Direct supervisor for R&D team• Multiple granted US Patents

• R&D Core team member on Premere PFO closure device programo Successfully led design updates for multiple device components and processeso Updates include changes made to improve product performance and changes to improve manufacturabilityo Interviewed and observed physicians at multiple locations to develop requirements for next generation device and current generation device improvements• Project leder for AngioSeal STS PLUS programo Created concepts for inclusion in AngioSeal STS deviceo Prototyped concepts & selected features for inclusion in STS PLUS deviceo Led program from concept phase through human use evaluation of STS PLUS• Conceptualized, prototyped and tested multiple technology concepts for AngioSeal device• Designed and constructed test methods and equipment• Led and executed multiple improvements on AngioSeal STS device designed to improve manufacturing and user satisfaction• Direct supervisor for 2 technicians• 7 granted US Patents• 20 US Patent Applications submitted to US Patent office

• Planned and executed concept, development and implementation phase activities on multiple projects:o 5F Guider XF Neurological Guide Cathetero NG Guide Cathetero Distal Protection Systemso 6F Wiseguide Coronary Guide Catheter• Prototyped multiple types of devices• Direct supervisor for 3 technicians and interns• 3 Granted US Patents• 6 US Patent Applications submitted to US Patent office