We create world class products and deliver them to market.

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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.

IMAGE OF FEA

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 prospectivedistributors & present vision for early buy in

R&D StrategyOpportunity & Business Case

Foundation ResearchInitial Research Investigation

TECHNICAL DEVELOPMENT

Research & DevelopmentDevelop Core Products

Certi!cationProduct Certi!cation & Accreditation

COMMERCIALISATION

License AgreementsHoA & Supply Agreements

Tech TransferTransfer of Assets to Distributor

Market ReleaseProduct Launch

Secure EarlyDistributor

Product EvaluationProduct Assessed by Distributors

Product TrialProduct Trial carried out by Distributor

Tech Transfer

CommercialisationEntry Phase

Pitch PresentationCreate Sales Presentation

Principal DesignProduct 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.