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NZ Health Congress 2013

NZ Health Congress 2013



A series of three presentations were delivered at the NZ Health Congress by Jono Jones (Locus Research), Professor Simon Fraser (Victoria University), and Timothy Allan (Locus Research). On the topics ...

A series of three presentations were delivered at the NZ Health Congress by Jono Jones (Locus Research), Professor Simon Fraser (Victoria University), and Timothy Allan (Locus Research). On the topics of FEA and Analysis in Healthcare, Additive and Rapid Manufacturing and Lean Startup



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  • Finite element analysis is the computational approach to solving complex problems with boundary conditions by dividing it into many small sub-functions and solving each in turn. This is commonly used to analyse physical performance and integrity of manufactured parts before commitment to production to provide surety the part will perform as required Used for part design optimization such as minimizing weight while maximising performance. Software such as ANSYS or FEMAP import parametric 3D file from CAD for the analysis
  • A virtual mesh is applied to the model and the intersection points are called nodes. Material characteristics and parameters are applied to the nodes to simulate the material.  Bed slat shoe for the Evolution sleep system This was a productionisation and Santoprene - Hytrel, half weight. Same feel
  • FDA encouraging simulation as parts of submission packages. To support animal, bench and human testing FEA is a requirement to achieve FDA approval for many devices that are implanted in the body – e.g. stents Recognised that better results can be derived from computational process
  • Finite element modelling and analysis is increasingly being used in medical device developments. This is an example by Bausch and Lomb the contact lens and eye health specialist who used FEA in a biomedical context to develop highly flexible  intraocular lenses (IOL) for cataract surgery. During cataract surgery a small incision is made in the cornea and the lens is inserted. Bausch and Lomb set the target to reduce this slit from 1.8mm to 1mm to reduce patient recovery time. What we are looking at here is a cross section of a lens insertion tool. The green shape is the highly flexible hydrophobic acrylic and silicone intraocular lens and the blue part is the inserter tip . As a result the flexible lens’ have to fold in the inserter tool and pass through the slit so FEA was used to analyse the strain on the lens and visualise the deformation as it passes through the applicator channel into the eye The FEA model was compared and calibrated against physical test data to ensure the peak strain measurements correlated to previously experienced real-world failures points. This simulation approach has resulted in higher assurance of what will work when production is committed and failure modes mitigated in use.
  • The traditional engineering development process places the analysis after the development to validate the design pre-compliance
  • Integrating analysis and simulation into the design cycles moving it forward in the process means designs can quickly evolve and improve. This is effectively making the shift from using simulation as a validation tool to a research tool which can be used to derive insights early in the process that can be translated into innovation.
  • This is an example where we used FEA to explore and research in a biomedical context. Since early 2011 we have been working with a start-up company in Tauranga to develop and take to market a range of hip protectors aimed at preventing hip fracture in the elderly. Hip fracture is a growing and pressing global issue with projections of hip fracture incidence to exceed 6 million annually by 2050
  • Describe the product
  • Designed and built a rig to the IHPRG standard but achieved different results when tested on another rig with a different configuration soft tissue model Background to project - Completed a research project at the start of this year with an intern from the bioengineering faculty of Auckland University to explore the use of FEA in the development of biomechanical test apparatus for hip protectors. Use the tool to model and analyse biological components which means replicating these materials in the software package - this is complex because these materials aren't linear isotropic materials like engineering polymers or metals, these are biology materials which have complex non-linear behaviours
  • Literature research to identify the mechanical characteristics of the bio components. Important point for the process that requires a range of research skills for the best results. Required digging deep into biological research to identify the parameters. Biological materials are complex and highly non-linear which is difficult to model. They are filled with water which is affected hydration levels and the collagen fibres create an anistropic property where the mechanical characteristics differ in different directions which means they require more complex computation. This demonstrates the need to currently run physical testing to best gather this information - stress/strain sample testing or indentation testing of biological tissues.
  • A long way to go with this model to calibrate it to a realworld response but plenty of insight was derived from the preliminary model A view into the leg making what was previously invisible, visible Which soft tissue areas are best to shunt the fall energy Stresses in the proximal femur Stresses in the femoral neck
  • Then we moved to translate the material knowledge into a more representative physical model Matching to artificial materials - silicone is the closest match because of the non-linear, viscoelastic properties 2 grades identified - one to represent skin and muscle, a softer grade for fat
  • Further physical impact testing to clarify the position
  • Once the model has been developed and calibrated we can then iterate our parametric CAD models, adjusting materials and geometries, import into the model and validate before committed to material expense Thermal analysis can be run to evaluate comfort related factors Pressure analysis for understanding pressure sores Possible that soft tissue can't be accurately represented in artificial materials due to material limitations so the most accurate simulation is computationally.
  • Lean manufacturing is well established in New Zealand. It is a philosophy which was originally develped withing Toyota after the war. Tai-ichi Ono is considered the father of the 'Toyota Production System' which has become internationalised as Lean Manufacturing and in relative terms has spawned all the other elements of this. Tai Ichi Ono - Toyota Production System - Beyond Large Scale Production. Brilliant in its symmetry and how it has come about. Essential if you want to really get it from the horses mouth.
  • The japanese have a poetic way of considering even the driest of topics. I have always loved their ceramics packaging and many other things. I consider Hideuki Oka's How to Wrap Five Eggs as master piece. Like the Haiku.
  • Learning first is a structured method of product development which places a value on the development of knowledge.
  • We apply some of these principles in how we work.
  • Test.....
  • The Critical Principles of Lean Startup.

NZ Health Congress 2013 NZ Health Congress 2013 Presentation Transcript

  • We create world class products and deliver them to market. www.locusresearch.com The Digital Body Computer Simulation in Medical Device Developments PRESENTED BY: Jonathan Jones TO: Health Congress 2013 DATE: 25.06.13
  • Accelerate Innovation – Building Blocks 1. Jonathan Jones – Computer Simulation 2. Professor Simon Fraser – Additive Manufacture 3. Timothy Allan – Lean Start-Up Models
  • What is FEA? FEA - Finite Element Analysis ⧁ Dividing complex models into many small sub- functions; ⧁ Interpretation into useful information; ⧁ Parametric input from CAD; ⧁ Software includes: FEMAP & ANSYS; ⧁ Used for design optimization & validation.
  • Encouraged by the FDA §  Encouraging simulation in submission packages; §  Support other test areas: animal, bench & human; §  A requirement for many invasive products; §  Recognise better results can be derived from FEA.
  • Bausch + Lomb Intraocular Lenses From Dassault Systemes case-study: www.3ds.com
  • Hip Protector Research & Development Preventing Hip Fracture
  • Further Opportunities •  Exploration of shield materials and form; •  Pressure analysis; •  Thermal analysis; •  Results maybe more accurate through simulation than physical materials
  • Power of Simulation ⧁ Shorten time to market; ⧁ Decrease development costs; ⧁ Validate more design options & complexity; ⧁ Improve product performance; ⧁ Discover new insights for innovation.
  • We create world class products and deliver them to market. www.locusresearch.com Lean Startup A different approach to commercialisation PRESENTED BY: Timothy Allan TO: Health Congress 2013 DATE: 25.06.13
  • Re-Track So we have heard about: ⧁ New methods of development & analysis. ⧁ New approaches to the rapidly developing wave of manufacturing methods. ⧁ Do we need a new business model?
  • The Lean Start-up This can apply to both established businesses & new business ~ it is an approach. ⧁ Originally proposed in 2008 by Eric Ries. ⧁ Based on simple principles. ⧁ Uses the 'Minimum Viable Product' MVP concept. ⧁ Is heavily based on the principles of Lean.
  • Back to Lean Lean is a concept that is well established in New Zealand manufacturing. ⧁ Create Flow ⧁ Eliminate Waste ⧁ Flexibility ~ Sensitive to Change ⧁ Pull - Processing ⧁ Customer Oriented (not push)
  • Wasted ⧁ Muda ("non-value-adding work"), ⧁ Muri ("overburden"), ⧁ and Mura ("unevenness")
  • Learning First A method of product development. ⧁ Drives development of knowledge initially not just products ⧁ Knowledge is then used to develop products ⧁ Wright Brothers to Team New Zealand. ⧁ Iterative in nature.
  • Minimum Viable Product (MVP) The cornerstone of the Lean Startup ⧁ Does not mean 'Minimal' product. ⧁ An iterative process of idea generation, prototyping, presentation, data collection, analysis and learning. ⧁ Delivers the features that enable a product to be deployed an no more.
  • Build-Measure-Learn "The fundamental activity of a startup is to turn ideas into products, measure how customers respond, and then learn whether to pivot or persevere". "All successful startup processes should be geared to accelerate that feedback loop". ~ Eric Ries
  • PDS RESEARCH Approach prospective distributors & present vision for early buy in R&D Strategy Opportunity & Business Case Foundation Research Initial Research Investigation TECHNICAL DEVELOPMENT Research & Development Develop Core Products Certification Product Certification & Accreditation COMMERCIALISATION License Agreements HoA & Supply Agreements Tech Transfer Transfer of Assets to Distributor Market Release Product Launch Secure Early Distributor Product Evaluation Product Assessed by Distributors Product Trial Product Trial carried out by Distributor Tech Transfer Commercialisation Entry Phase Pitch Presentation Create Sales Presentation Principal Design Product Range & Technology Discovery PDS Concept Embodiment/Detail Commercialisation
  • Healthcare's Challenge There are some key issues that have to be considered at the start of the process. ⧁ IP - your investment requires you to protect it. ⧁ Process - emerging compliance requires you to follow a structured process. ⧁ MVP - can you get by with a minimum level when you are dealing with medical devices, software and pharmaceuticals? ⧁ Access to patients/clinicians- can be hard if your just starting out.
  • IP It is possible to protect in an iterative cycle. ⧁ File pro-actively in advance of disclosure. ⧁ Create a small group of users where disclosure can be adequately controlled. ⧁ Decide what is important, rather than trying to protect everything. ⧁ Place a commercial value on speed to market.
  • Process An iterative process can still fall within a structured development process. ⧁ Build, measure, learn is a principal which should be a core part of NPD activity. ⧁ Document all activity and outcomes and build in higher level reviews. ⧁ Create a Meta Structure above your iterations to document and drive change and improvement.
  • MVP 'Minimum Viable Product' is as important in medical as in other applications. ⧁ Don't polish the silverware. ⧁ Focus on the essential and critical elements and drive into the feedback loop as quickly as possible. ⧁ Have a culture that accepts change is ok and it sometimes has to be significant. ⧁ Build releases into your development timeline rather than waiting to finish.
  • All Together ⧁ Simulation/Analysis - can speed up iterations and reduce waste. ⧁ Rapid and Additive Manufacturing - can produce products more quickly after analysis. ⧁ Lean Startup - pushes you to market quickly and forces you into a fast feedback loop.