The Manufacturing Executive · 2 Mar 2021 · 28m · Episode 38
Van Carlson, founder and CEO of Strategic Risk Alternatives, discusses risk management strategies for manufacturing executives, focusing on the shift from traditional insurance to self-insurance mechanisms like the Section 831(b) tax code. He explains how manufacturers can mitigate rising premiums and coverage gaps by building reserves for unfunded risks such as supply chain disruptions, product recalls, and business interruption. Carlson emphasizes that these tools allow business owners to defer taxes and create a 'war chest' to handle claims without impacting operating cash flow, a practice increasingly vital in the post-pandemic economic landscape.
early-stage companies
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Jimmy Diresta, Bob Clagett, and David Picciuto discuss the legal liabilities of making and selling physical products, the high cost of insurance for custom work, and strategies for budgeting in content creation and client projects. They cover specific safety concerns, such as the use of SawStop table saws and personal protective equipment, and share anecdotes about product liability risks in both professional and hobbyist contexts.
Michael Cremeans, Life Sciences Industry Practice Leader at Hylant, joins host Jon Speer to discuss how medical device companies can manage enterprise business risk beyond just product safety. They cover the importance of engaging insurance experts early to navigate complex contractual liabilities, such as those found in term sheets and group purchasing organization agreements, and how robust quality systems like those in Greenlight Guru can improve insurance outcomes. Cremeans emphasizes that companies should not treat insurance as an afterthought but rather integrate risk management into their overall business strategy to protect against financial and legal damages.
Edwin Bills, a lead expert in medical device risk management and key contributor to ISO 14971, explains how his background as a submariner and manufacturing quality engineer informs his approach to patient safety and cost of quality. He details the critical link between manufacturing process capability (CPK), supplier quality, and financial risk, arguing that quality failures directly impact a company's bottom line and reputation. Bills critiques common industry practices, such as late-stage FMEA and manual spreadsheet-based traceability, advocating for early hazard analysis, industrial statistics, and integrated software solutions to manage complex risks in medical devices and combination products.
Jimmy Diresta, Bob Clagett, and David Picciuto discuss their recent projects, including Diresta's molding and casting experiments with Alumilite and Smooth-On, Picciuto's CNC work and wedding rings, and Clagett's one-board challenge. A significant portion of the episode is dedicated to the complexities of business insurance, with Diresta and Clagett sharing frustrations over rising premiums, coverage gaps, and bureaucratic hurdles when dealing with equipment loans and state regulations. The hosts also recommend resources like the Essential Craftsman YouTube channel and discuss the importance of high-quality educational content from manufacturers.
Elliot Lewis, CEO of Keyavi, explains his company's 'self-protecting data' technology, which embeds security policies and encryption directly into data files to control access regardless of location or device. Dan Breznitz, a professor at the University of Toronto, discusses the challenges of bringing manufacturing back to the U.S., citing the loss of supply chains, skilled labor, and financial incentives that favor offshoring. The episode highlights the fragility of global supply chains exposed by the pandemic and the trade war with China.
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