Greater Chicago Area
Brings a unique mix of 15 years’ experience in Product Development and 15 years’ experience consulting as a Quality Engineer and in Risk Management. Work experience spans start-ups to major corporations. Specializes in general solutions to challenging Risk Management issues, e.g., A method to assess Benefit-Risk that is significantly more objective than SOTA, has no limits on the number of factors considered, produces traceable logic on which is larger, and works for drugs, devices, biologics, combination products, and clinical trials. A policy for establishing criteria for Acceptable Risk that is grounded in regulatory rulings and applicable to a wide range of medical devices. A method to establish sample size that is truly risk-base, as opposed to most methods that rely on probability but not severity, or severity but not probability. An approach to product development that fully integrates risk throughout the process, including designing product architecture based on risk, A method to establish the probability of software errors, A risk-based method to reduce product documentation, Etc.
Risk Management / Biocompatibility Consulting 2023 Created a comprehensive Risk Management system from a combination of borrowing from sister divisions and improving upon existing procedures; Introduced comprehensive risk management of cross-species allergic reactions to animal peptides and zoonotic transmission of diseases; Developed a unique and comprehensive pFMEA document that enables pFMEAs to be created in pieces and assembled into a whole - including common processes with different risks in different products. Method Patent to compare Benefit and Risk - 2021 to present Identified and refined a method of measuring benefit and risk using the same metric. By using the same metric to measure both benefit and risk, it makes the direct comparison of benefit and risk possible. The invention of 'risk algebra' enables complex mixes of risk and benefit to be simplified - with the result being obviously defensible claims that risk outweighs benefit or benefit outweighs risk. Expect this to have a significant impact on the development of medical products, since both FDA and MDR require proof that benefit outweighs risk as a final metric before the sale of products. I continue to discuss / refine the idea with professional groups specializing in risk management, with key influencers within the Risk Management community, with FDA, and with the ISO techinical committee on risk (e.g., the authors of ISO 14971). I am also working with the US and International Patent Offices on a non-provisional patent. The US Patent and Trademark Office application number for a non-provisional patent is 18/643,355. I launched the 'Aspen Medical Risk Consulting' company to leverage this benefit-risk analysis method across the many uses of benefit-risk across all areas of medicine.
Fund raising for a start-up water-based cremation company, to provide low-cost, low-emission cremation of human remains. Qico's value proposition surpasses the competition with both its revolutionary cremation process and an offering of previously unavailable proprietary products, services and scattering options. https://www.qicoinc.com/
Risk Management / Biocompatibility Consulting 2019 – 2022 Combination of employee coaching and identifying new, more efficient work options. In response to inadequate legacy DHF documentation, introduced Fault Tree Analysis as a tool to identify the 5-10% of component features and production process parameters that are critical-to-safety for expedited attention. In response to inadequate pFMEA for EU MDR submissions, member of a small team that designed a new pFMEA approach which fulfilled submission requirements. In response to weak design skills, developed a standard tool for design / CAPA work. Identified gaps in biocompatibility and wrote procedures to close them. Developed work automation tools to improve employee efficiency / train employees critical thinking. Biocompatibility Consulting 2018 – 2019 Managed / initiated the creation of hundreds of biocompatibility reports for Zimmer Biomet across 9 business groups. Escalated significant issues to senior management and improved biocompatibility procedure. Risk Management Consulting 2018 Created a risk assessment tool for Misonix’s five product families, ensuring alignment with a half-dozen regulatory standard and legacy risk assessment plans. Revised risk management procedure to reflect significant differences between 93/42/EEC and ISO 14971. Combination-Product Quality System Development 2017 - 2018 Revised Pfizer’s corporate post-market reporting procedure to align with new FDA guidance on combination products, and numerous internal and external audit findings (including the biocompatibility impact of the liquid drug on wetted components). Worked with senior combination-product management to ensure a site-initiated solution would align with present and anticipated corporate processes.
2019: Membership Chair 2018: INCOSE Assoc. Director of Recruiting and Retention for Sector 1. 2016 - 2017: President: Led chapter meetings and board meetings. Directed board member activity. Built links to professional societies, U of W at Fond du Lac, and membership retention initiative. Raised chapter performance from Gold to Platinum level. 2015: Vice President: Support the President & other officers. Maintain evidence of chapter events for the annual 'Circle Award'.
Actively manage cross-functional product development teams to significantly increase a company's value in the medical devices, energy, automotive, entertainment and aerospace industries. • Work with clients to develop proposals and manage the engineering team for accepted proposals. • Establish aggressive, de-risked project schedules with the engineering team, including determining the mix of technical skills and size of the team. • Manages the client / management relationship, including reports on progress and finances. • Lead the resolution of technical conflicts and drive the project to a successful conclusion. • Highly independent - takes direction and runs with it, but also knows when new information is needed. Projects included a relabeling a MRI; a personal rapid transit (PRT) system; a gas detector; and a home-based, health monitoring system.