Artixio_Accelerators & Incubators MedTech.pdf
- 1. www.artixio.com 2023 ARTIXIO CONSULTING EXCELLENCE IN LIFESCIENCES, FROM CONCEPT TO MARKET Incubators & Accelerators – Opportunities for Students & Faculties – Early Stage Entrepreneurs Session on Presented by For
- 2. Artixio| Incubators & Accelerators – High Level Comparison INCUBATOR ACCELERATOR Office Space Yes May be Mentorship Yes Yes Networking Opportunities Yes Yes Funding Sometimes Yes / Connect with Investors Yes / Connect with Investors Equity Model Usually Fee based / May ask Equity Equity Based Technical Facilities Yes May be Type of Engagement Rolling Based Admissions Cohort based Legal Yes Yes Regulatory Yes Yes Marketing Sometimes Yes Financial Advice Yes Yes Stage of Development Early Stage – When Product/ Business Model is not defined Growth/ Scaling - Clear Product/MVP, Business Model Timeline 6-12-24 Months Long Term Sustainable Growth / Flexible Duration 3-6 Months Rapid, Efficient Scaling / Fixed Duration Industry Focus Industry Specific / Often General Industry Specific
- 3. Artixio| Incubators & Accelerators – How To Chose? Ideation MVP Investment Validation Launch Growth Maturity Exit Accelerator Venture Capital Incubator WHERE ARE YOU IN THIS JOURNEY?
- 4. Artixio| MedTech Incubators & Accelerators – In The MEDTECH Context Coverts your MedTech Idea into viable business model with additional support relevant to the Industry Principles of risk based methodology QbD- Product Design Support tech gap areas- excluding core competency Regulatory requirements- Regulatory Strategy Adopt to business needs at an accelerated pace to cope up with a market which is continuously evolving Determining market gaps for innovation adoption- Market Strategy Forming business partnerships- Customer acquisition Funding / Capital Infusion INCUBATORS ACCELERATORS
- 5. Artixio| MedTech Incubators & Accelerators – Case Study – 4BaseCare Founded Incubated Accelerator 6 Startups Cohort Support Provided $10K Equity-Free Cash Grant Technology Business strategy Regulatory and clinical validation Edison Platform Sales Team Accelerator 5 Startups Cohort Support Provided Seed investment Business and scientific guidance Access to Illumina’s sequencing systems Reagents Fully operational lab space for six months Genomic tests for Cancer Patients' treatment guidance, A mobile-based patient-centric EMR. Won Elevate 2019 INR 50 Lakhs 4baseCare and ACTREC-Tata Memorial Centre - AI based clinical interpretation platform Grant Partnership Partnership Growth Partnership Investment $2M 2021 2018 2019 2020 2021 2022 2023
- 6. Artixio| MedTech Incubators & Accelerators – What Do They Offer? Business mentorship and Technical mentorship for fostering medical device entrepreneurship Information and support in setting up a business venture with finance, legal, HR and regulatory inputs Professional assistance in risk analysis, regulatory compliance, quality management system, technology documentation, product documentation, ethical clearance Training on biocompatibility, risk management, human factors engineering, packaging and sterilization, selection of biomaterials, quality management systems, regulatory systems and documentation.
- 7. Artixio| MedTech Incubators & Accelerators – What Do They Offer? Office space on rental Laboratory facility Wet lab Laboratory facility Dry Lab Clean work space Specialized Utilities Chemical, polymer, biochemistry, biotechnology, ceramic & related projects with reagent racks, fume hood, facility of laboratory gases, electrical power and basic equipment such as weighing balance, refrigerator, heater, stirrer, oven, shaker, air compressor/vacuum Electro-mechanical, instrumentation projects with electrical power (light loads), internet connectivity Laminar flow work bench) – for final assembly or manufacturing process and also shareable clean/non clean work space for cleaning, drying, packaging and sterilization Reagent water, ultrasonic component cleaning equipment, sealers for medical device packing and ETO/ Steam sterilizers INFRASTRUCTUE at MEDTECH INCUBATORS MEDTECH FACILITIES Analytical characterisation facilities (HPLC, LCMS, GC, TGA, DTA, UV, FTIR, FT Raman, AFM ...) Microscopes (TEM, SEM, ESEM, Confocal, Optical, Projection stereo...) Mechanical characterisation facilities (Tensile / Compressive, DMA, Burst, impact, fatigue ..) Surface Characterisation facilities (Roughness, texture, profilometry..) Coating Characterization facilities (thickness, adhesion, corrosion …) Medical device in vitro evaluation facilities, In silico validation facilities Design workstations and design software Structural Analysis and Computational Fluid Dynamics software Metrology and calibration OTHER SERVICES ACCESS Testing services on material characterisation and biological evaluation Large animal experiments Consultancy on risk analysis, regulatory compliance, quality management system, technology documentation, product documentation, ethical clearance IP services, Library and information Services Support from clinical community, Clinical trials coordination
- 8. Accelerator 'Madhavbaug,' one of India’s largest Ayurveda Cardiac Care clinics https://fhealth.in/ D2C, home healthcare, telemedicine, patient-centric innovations, medtech and digital therapeutics $1.5 million across 8-10 companies over three batches in FY 23 Acclerator Government of India Biotechnology Industry Research Assistance Council (BIRAC) and Tata Trust enabled Social Alpha https://hiex.ch/innovations.html Cancer Care, Drone Logisctics, 3D drug Delivery, UAV Incubator IIT Kanpur, DST https://siicincubator.com/programs-nidhi- accelerator.php Agritech, Cleantech, Cybertech, Education, Fintech, Hardware, Healthcare, Infra, AI/ML/IoT, UAV 100+ Companies, $1B+ Valuation Accelerator https://actionforindia.org/ Social Healthcare, Remote Health Monitoring, Diagnostics, Insurance 10+ Healthcare/MedTech startups Accelerator mPragati – IIT-D / ICMR, DHR https://www.mpragati.in/ Implants Surgical Instrumentation Electronic Instrumentation Rehabilitation 20+ Startups Incubator IIT-M Dept of Biotech, MST https://htic.iitm.ac.in/mti/ Telehealth, Diagnostics, Invasive/ Non Invasive Devices 12+ companies already in market Grant upto INR 50 Lakhs Artixio| MedTech Incubators & Accelerators – Examples
- 9. Incubator Andhra Pradesh MedTech Zone (AMTZ), Medi Valley Atal Incubation Centre MedTech Innovations, Woman Care, Elderly Care, Rehabilitation 10+ startups Incubator Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Kerala State Industrial Development Corporation Department of Science & Technology, Government of India Eye care, diagnostics, Ventilators, Urinary hospital care, telehealth, diabetes Seed funding support 20+ starups Incubator IIM-A, NIDHI Seed Support, Bharat Inclusion Seed Fund, Infuse Ventures Telehealth, IOT, Wearable devices, Assistive Devices, Predictive Devices Upto 50 startups funded per year Incubator GoI, Govt of Gujrat HealthTech, Diagnostics Incubator IIMB, NS Raghavan Centre for Entrepreneurial Learning HealthTech, Diagnostics, Genetic Screening 30+ Stratups Incubator / Accelerator https://startupmission.kerala.gov.in/ Healthtehc, diagnostics, devices 40+ Incubators network Artixio| MedTech Incubators & Accelerators – Examples
- 10. Incubator https://entrepreneurs.unltdindia.org/ Shahani Group Initiative Health Information, Social Healthtech 5+ healthtech startups Incubator DA-IICT Centre for Entrepreneurship and Incubation (DCEI) http://ceid.daiict.ac.in/index.html#about HealthTech Incubator IIM C https://www.iimcal.ac.in/faculty/centers-of- excellence/centre-for-entrepreneurship- innovation/iim-calcutta-innovation-park HealthTech Incubator http://www.ndbiindia.org/index.html Mobility, healthTech Incubator http://www.mutbimanipal.org/our-incubatees Rehabilitation, Diagnostics, Stem Cell, eLearning 20+ Startups Incubator / Acclerator https://periyartbi.pmu.edu/ Medical Devices, Food Biotech, Butrition 10+ Stratups Artixio| MedTech Incubators & Accelerators – Examples
- 11. Accelerator https://www.edison-accelerator.com/ Digital Transformative Healthcare 10+ Start-ups Accelerator https://startup.google.com/programs/accelerator/india / Google for Startups Deep Tech, AI/ML HealthTech 10+ Start-ups in India Incubator / Accelerator https://www.ikpknowledgepark.com/incubatees.html Pharma, MedTech, Healthcare, Biotech, Diagnostics 65+ companies Artixio| MedTech Incubators & Accelerators – Examples
- 12. Artixio| MedTech Industry Overview Medical device industry is broadly segmented into devices and diagnostics Projected to grow around $600 billion in 2025 with continued CAGR of about 6% till 2030 5 Major Categories of Devices & Diagnostics • Consumable & Disposable Devices • Imaging Diagnostic • Dental Products • Orthopaedics & Prosthetics • Patient Aids • Software/Digital Products Semi-Regulated Industry Ambiguous requirements depending on technology & country Wide technology breadth and application depth Varied Innovation Cycle Across product category Maturity vs Growth Stage Key Trends Across Product Categories based on Innovation Cycle Wearables | Immersive Tech | 3D Printing | IoMT | AI | Minimally invasive devices
- 13. Artixio| MedTech Industry Overview | India Focus India is the 4th largest market for medical devices in Asia, among the top 20 markets globally $11B Market Size $50B By 2030 15% Market Growth Rate (expected) 6,000 + Types of Medical Devices in India 250 + MedTech Startups X 4 by 2030 70% Import Market 9.37% Export CAGR $10B Export by 2025 Production Linked Incentives: Government has launched Production Linked Incentive Schemes for medical devices with financial incentives worth $400mn to boost domestic production Development of Medical Devices Parks: New Medical Devices Parks upcoming in Himachal Pradesh, Uttar Pradesh, Madhya Pradesh, & Tamil Nadu to create a robust ecosystem for medical device manufacturing Policy Support: Release of National Medical Devices Policy to enable strong collaborations for boosting medical devices ecosystem & National R&D Policy to foster interdisciplinary collaborations to develop translational skills & start-up ecosystem Significant Infrastructure, Policy and Funding Support from the Govt. of India The Drugs and Cosmetics Act, 1940 Sources: https://www.investindia.gov.in/sector/medical-devices https://www.ibef.org/industry/medical-devices
- 14. Artixio| MedTech Product Development Overview Market Research and Needs Assessment Concept Generation Feasibility Assessment Proof of Concept Prototype Development Design and Engineering Functional Prototypes Iterative Testing User Feedback Regulatory Considerations Manufacturability and Scalability Pilot Testing Regulatory Submissions Technical Documentation Continuous Improvement
- 15. Artixio| MedTech Industry – Key Considerations Global Harmonization 1. Global markets each with its own regulatory framework. 2. Global harmonization of standards and regulations is a big challenge,due to adaptation to different sets of requirements Evolution of Regulations 1. Redefine regulations to align with technological advancements and patient safety. 2. Ensuring compliance to evolving regulations is a huge task Classification and Risk Management 1. Proper classification of medical devices based on their intended use and potential risks is crucial. 2. Risk management and all the other associated requirements is extremely crucial Pre-Market Approval 1. Pre-market approval before commercialization 2. Rigorous assessment of clinical data, safety, and efficacy and Quality system audit REGULATORY INTELLECTUAL PROPERTY Patent Protection Innovation in medical devices is crucial but the associated patent protection is crucial, costly and leads to patent disputes and challenges Trade Secrets and Confidentiality Approach of replication or reverse- engineering of devices is very high in medical device industry. Establishing robust trade secret protection measures is vital Licensing and Collaborations Collaborations and licensing agreements can complicate intellectual property ownership TESTING Clinical Trials Substantial equivalence and clinical studies are required to prove the safety and efficacy of the device Post-Market Surveillance Implementing effective post-market surveillance systems and promptly addressing any concerns is a regulatory obligation Validation and Verification Indepth validation and verification processes is a must for medical devices to comply to regulatory standards Labeling and Instructions Global Labelling requirements are very complicated and complex for medical devices. Any non-compliance can cause a serious impact on the product status in the market
- 16. Artixio| MedTech Industry – Navgating Global Regulatory Pathways