Consultancy services for Management, Technical and Operational Issues. Pre and Post Investment Due Diligence. Oversight, Review and Proposals for Venture Capital and businesses at all levels of development.
- Due Diligence
- Decision Support
- Product and Technology Assessment
- Risk Assessment (Product, Market and Regulatory)
- Portfolio Analysis (NPD)
- Trademarks and IP
- Strategy
- Recommendations
General Manager - NEXAN, plc.
Cambridge, UK (1999 - 2003)
Recruited to bring new product to market in the minimum timeframe. Resized and redefined organization to meet these needs. Subsequently responsible for refining entire UK organization to meet all stated objectives in a time and cost efficient manner. Introduced cost optimization programs (manufacturing) and effective future planning. All milestones met.
Responsible for all operational aspects of the UK arm of the business, from product conceptualization, design and specification through development into manufacture. Involvement and responsibility in generation of second round funding ($18MM) for this venture funded business. Full fiscal responsibility for forecasting, projected and actual spend. Member of the Board. Business closed due to finance constraints within investor group.
All business objectives met in a timely manner within budget.
- Developed high energy organization operating in compliance with ISO 9001 and FDA GMP requirements.
- Member of Board and Global Executive Team. Established and empowered UK Management Team.
- First FDA product from concept to FDA 510(k) approval in 11 months. Previous cycle > 2 years.
- Active involvement in second round funding activity. Developed strong reputation for delivery with all investors.
- Introduction of improved planning/product development model within the business resulting in reduced development cycle time and improvement in project costs.
- Successful capture of Contract Manufacturers despite low product volumes. Cost (Margin) improvement in all product areas.
Vice President – Worldwide Research and Development JOHNSON & JOHNSON, INC. – CRITIKON
Tampa , FL (1996-1999)
Recruited to turnaround existing development group who were suffering from low morale and failing to meet planning schedules and budget commitments. Reorganized functions including downsizing with outsourcing of manufacturing optimization skills identified as lacking within the group. Effectively re-motivated group with subsequent on target product launch/budget control. Introduced formal New Product Development process specifying compliance to timeframes and budget while meeting quality standards. Change agent within the organization including strategy/strategic partnerships, specifications, number qualification and successful external cost reduction program. Operated development program for key staff members.
Operational accountability for 100+ staff Worldwide $15MM annual spend. Group managed as internal business with full fiscal responsibility for forecasting, projected and actual spend. Key member of divestment team.
- Successfully merged two geographically remote R&D groups enabling synergies and resultant overall effectivity improvement of > 40%.
- Revised product development model within the business resulting in reduced development cycle time and improvement in project costs.
- Introduced measurement and development processes to the business enabling ‘total business’ impact analysis of commercial opportunity (Risk/Benefits) vs. development/manufacturing impact.
- Ensured subsequent product stream launches met planned timescales.
- Championed identification and presentation to the business new business/new product opportunities for board approval and inclusion in portfolio.
European Technical Services Director Johnson & Johnson – Ascot, UK
Johnson & Johnson – Ascot, UK (1982-1996)
Accountable for 25 staff throughout Europe $4.5MM annual spend. Group managed as internal business with full fiscal responsibility for forecasting, projected and actual spend.
Responsible for acquired R&D Group based in Wales, UK. Successfully relocated and redirected group to ensure on time commercialization of high tech laser based medical monitor. Championed development of low cost non invasive blood pressure monitor. Planned and implemented company European Commission Device Directive approvals (European CE mark).
- Broke existing development paradigm to design and develop fast track low cost patient monitor (now company mainstay) while meeting budget and time based milestones.
- Directed group for development of ‘cutting edge’ 4 wavelength Near Infra Red Laser based tissue spectroscopy monitor enabling unique measurement of tissue oxygenation and utilization within the brain.
- Enhanced commercialization of NIR spectroscopy by providing Marketing with additional Research and Clinical support within the area of application.
- Managed successful compliance programs ensuring product lines achieved Electromagnetic Compatibility Directive(EMCD) and Medical Device Directive (MDD) CE mark approvals.
European Technical Services Director
Johnson & Johnson – Ascot, UK (1989-1992)
European are responsibility. Budget responsibility $2.2MM annual . Group managed as internal business with full fiscal responsibility for forecasting, projected and actual spend.
- Led Regulatory, Technical and Clinical activities of franchise in Europe. Worked closely with European Marketing group to define new products, including successful introduction of European Oxyshuttle II monitor (via US OEM strategic partner). Included setting up/ownership of, Pan European manufacturing ISO auditing, product complaints procedure/analysis implementation and Clinical Trials activity for the franchise. Continued involvement in European product sourcing with development of two independent syringe pump ranges ( UK and Italy).
- Recruited and developed Pan European Organization which included Regulatory/Quality, Technical and Clinical activities for the franchise.
- In conjunction with Marketing, specified and externally developed two I.V. syringe pump ranges, successfully extending the existing vein/artery access range and market opportunity.
- Developed and ran European franchise compliance program for ISO (European product standard compliance) and FDA GMP, including undertaking and supervising ISO 9000 series audits for manufacturing locations in Europe and US to ensure continued GMP compliance.
Business Manager
Johnson & Johnson – Ascot, UK (1988-1989)
Combined Product Management and New Business Development role. In addition to Brand Manager responsibility for UK Vein/Artery Access product range (disposables), also ran sourcing of line extension/new products to the brand(s) involving external development with UK, US and Japanese companies with considerable travel to all locations. Application of negotiation skills. Active involvement in industry association (DHAEMAE).
- External (Partnering with US and Japanese OEM suppliers) development of custom intravenous fluid sets and accessories to provide ‘full range’ of disposables; enabled 13% year on year growth (volume) for catheter brands.
- Active member of IV catheter standards advisory group DHAEMAE promoting standards beneficial to business. Successfully influenced coding standards preventing cost impact of standards driven changes to catheter product range.
Senior Development Engineer
Tampa , FL, USA (1987-1988)
- Selected for inclusion in International Development Program (IDP), involved temporary relocation to company Headquarters in Tampa FL. Introduction to global regulatory and clinical support requirements for overall product range. Opportunity to gain wider perspective.
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- Education to company systems, US based Quality approach, FDA GMP/510(k) approvals requirements
- Ran International Standards approval program.
- Lead Development Team for Non Invasive Blood Pressure/Oxygen Saturation monitor through launch to post market surveillance.
Product Manager
Johnson & Johnson – Ascot, UK (1984-1987)
- Responsible for marketing of all products within Patient Monitoring product Portfolio (Electronic Monitoring). Involved in local sourcing of hardware. Responsibility for UK/Export product approval and Department of Health registration. Undertook manufacturing audits at all manufacturing locations (US and Europe) Active in development of standards for Good Manufacturing Practice (DoH GMP). IV catheter patent approved.
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- Conception and execution of strategic marketing activity resulting in Business Growth of 266% (84-87).
- Introduced ISO standards to company suppliers, undertook audits to ensure DoH GMP program compliance (Italian and US IV Catheter manufacturing locations).
- Development of local (European) product solutions; exploration for potential partners in innovative technologies (biocompatibility, operation).
- Provided Regulatory support for the franchise.
Technical Services Manager
Johnson & Johnson – Ascot, UK (1981-1984)
- Responsible for setting up UK technical service department (company startup) establishing links into UK Department of Health, British Standards Institute. Product registration and approvals.
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- Recruited engineers and established UK technical service department. Use of department as profit center, innovative ‘on site’ PM contracts program.
- Negotiated design changes with supplier and export territory approval authorities (Scandinavia/Middle East) to enable on time minimum cost standards approvals.
- Presented product/clinical training programs for UK sales force and export distributors (on location).
Chief Medical Physics Technician - UK NATIONAL HEALTH SERVICE GUILDFORD HOSPITAL GROUP
Guildford , UK (1968-1981)
- Management of all physiological measurement departments for all hospitals within the group; EEG, ECG, Respiratory Function, ICU monitoring technical support. 4 major hospitals within the group >850 acute beds. Research into high frequency ventilation. Joint author of Clinical papers on the topic.
- HNC Medical Physics and Physiological Measurements (1976).
- ONC Medical Physics and Physiological Measurements (1974).
Anaesthesia, 1982, Volume 37, pages 675-679; Davey, Lay and Leigh.
High Frequency Venturi Jet Ventilation A functional analysis of the Penlon Nuffield Series 200 Ventilator.
Anaesthesia, 1982, Volume 37, pages 947-950; Davey, Lay and Leigh.
High Frequency Venturi Jet Ventilation Comparison of a proximal central jet with a distal wall jet.
EPO 86301824.8 Catheter for Intra
vascular Use.
US 09/591,597 Portable remote patient telemonitoring system (PCT WO 01/93756 A2)
US 09/590,996 Portable Data logger (PCT WO 0193753 A1)
US 09/950,961 Disposable vital signs monitoring sensor band with removable alignment sheet (PCT/GB 01/04091)
US 6454708 B1 Portable Patient Telemonitoring System using a memory card or smart card
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