# 199 - How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-07-30
- Length: 42m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/199---How-Modeling-Can-Cut-in-Half-for-Combination-Products--VV-40--and-Cutting-Dev-Time-with-Mark-Burchnall-e367952

## Summary

Mark Burchnall, Director of Engineering at PSN Labs, explains how mechanical modeling and simulation can reduce prototype iterations by 50% in combination product development. He details the use of Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) to support regulatory submissions under ASME V&V 40 standards. Burchnall emphasizes defining a 'question of interest' and assessing model risk to establish credibility, allowing models to replace or complement physical testing for high-risk design decisions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=0) Introduction: Mark Burchnall and PSN Labs
- [1:27](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=87) Subhi’s Drain Bag Failure and Modeling Solution
- [4:43](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=283) FEA, CFD, and Reducing Prototype Iterations
- [11:38](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=698) Model Life Cycle and Credibility
- [15:14](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=914) Inputs: CAD, Material Properties, and Drug Viscosity
- [24:33](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=1473) ASME V&V 40 and Risk-Informed Credibility
- [31:40](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=1900) Regulatory Guidance and Internal Procedures
- [39:28](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-30-199-how-modeling-can-cut-in-half-for-combination-products-v-v-40-and-cutting-dev#t=2368) Ideal Implementation and On-Market Remediation

## Topics

- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Prototyping & iteration](https://hardwarepodcasts.com/topic/prototyping)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- PSN Labs (company)
- ASME V&V 40 (other)
- Finite Element Analysis (tool)
- Computational Fluid Dynamics (tool)
- FDA (company)

## Related episodes from other shows

- [Industrial design prototyping vs simulations - IDology #21](https://hardwarepodcasts.com/podcast/idology/2024-04-30-industrial-design-prototyping-vs-simulations-idology-21) (IDology)
- [S5E19 Krishna Raichur | The Ins & Outs of Engineering Simulation (FEA, CFD)](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-05-10-s5e19-krishna-raichur-the-ins-outs-of-engineering-simulation-fea-cfd) (Being an Engineer)
- [S5E15.5 PDX: Ian McEachern](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-04-17-s5e15-5-pdx-ian-mceachern) (Being an Engineer)
- [How Simulation Technology is Reshaping Product Design w/ Dr. Masha Petrova](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2024-05-21-how-simulation-technology-is-reshaping-product-design-w-dr-masha-petrova) (The Manufacturing Executive)
- [#010: Andre Brown - Principal Engineer on Amazon's Transportation Sustainability Team - Digital vs. Physical Prototyping, Creating Flat Hierarchies within Teams, Innovating Faster, Designing in Virtual Reality, Eggs and Vacuum Cleaners, Procedural Design.](https://hardwarepodcasts.com/podcast/designing-in-the-wild/2022-03-01-010-andre-brown-principal-engineer-on-amazons-transportation-sustainability-team) (Designing in the Wild)

## Citing this page

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