Frugal Biodesign A systems approach for medical devices innovation Sudesh Sivarasu PhD Associate Professor University of Cape Town South Africa Conflict of Interest None South African Medical Device Industry ID: 767326
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Frugal Biodesign: A systems approach for medical devices innovation Sudesh Sivarasu PhDAssociate Professor – University of Cape Town, South Africa
Conflict of Interest None
South African Medical Device Industry This trade deficit can be reduced by reduced if medical devices are locally made
Solution to this problem?
Frugal Biodesign™
Medical Product Development Process (MPDP) New Programme on Medical Device Design in UCT adopts this process Several faculty members across Africa trained in this programme SOLUTION THROUGH A MEDICAL DEVICE THINK TANK
Phased Medical Device Innovation Process Opportunity to create a consultation / services platform
Change of Focus Facilitates Innovation
Case Study: Anaphylaxis Anaphylaxis Current Devices are not affordable Not intuitive to use Not designed for all of us Competitors include EpiPen Auvi -Q Jext
The ZiBi Pen Reloadable Cost Effective Clinically Effective Intuitive to use Safe I.P - ( PCT/IB2018/051623)
Market Distribution Global Market is rising steadily . 30% of the market is available . U$6 Billion Globally by 2026 U$2 Billion Globally 2018
Paediatrician & Allergy Specialist Innovators and UCT IP holders Manufacturers IP: PCT & Granted Clinical Resources Team Lean Validation Cost Effective Innovative Understanding of Developing Markets Business – Business Service Pharmaceutical Companies Medical Device Companies Users: Patients with Anaphylaxis Direct Sales Partners Pharmacies Trials Research & Development Marketing & Sales Manufacturing Trials Technology Development CE, CFDA, FDA, MCC Marketing & Sales Sales of Devices Licensing Subscription Revenue
Competitive Landscape Expensive Affordable Clinically Ineffective* Clinically Effective ZiBi Pen
The ZiBi Pen 5 ZiBi Pen Patentability U.K Provisional and PCT
15 Sudesh.Sivarasu@uct.ac.za sudeshsivarasu@gmail.com Dr. Sudesh Sivarasu, B.Eng., M.Eng , Ph.D Associate Professor - Biomedical Engineering, Head of Medical Devices and Orthopaedic Biomechanics Research Group, Division of Biomedical Engineering, Department of Human Biology, University of Cape Town, Medical School, Anzio Road Observatory, Cape Town South Africa 7925 www.bme.uct.ac.za www.frugalbiodesign.org