Viswanath Srinivasan’s Post

Med-tech startups excel in pioneering precision health technologies that take us closer towards making universal healthcare a reality. By reinventing healthcare systems by combining genomics, precision drugs & therapies with analytics, diagnostic devices, monitoring wearables, and telemedicine powered by Edge Al, sensors & robotics to deliver personalised, precise, predictive, and preventive care - these startups bring affordable, available, and accurate healthcare for anyone, anywhere, and anytime. However, navigating the regulatory path towards gaining the necessary certifications can be challenging and time-consuming - delaying time-to-market, and putting these startups behind the competition. These startups can, however, expedite regulatory approval by acquiring a test license to manufacture medical devices. This can be achieved by submitting an MD12 application, which serves as a request for a temporary authorisation to manufacture devices for testing, evaluation, and clinical investigations to the Central Drugs Standard Control Organisation (CDSCO), the regulatory body governing medical devices in India. The MD12 application requires documentation of 16 checklist items, including a cover letter - a critical first step towards obtaining a test license. This blog - aimed at guiding med-tech startups through this critical first step of putting together a winning cover letter for MD12 application - is the first in a series aimed at helping founders understand the steps involved in certifying their medical devices. Forge Innovation & Ventures is a vertically integrated enterprise for building and operating a national-scale Innovation Value Network to catalyse talent, technology and ventures with the core purpose of powering India’s innovation economy in the industrial digital age. Forge operates in the entire innovation value chain covering talent transformation, technology labs, product innovation, startup incubation, venture acceleration, and seed investments - enabling transformation of India’s industrial sectors through programs with academia, industry, and government. Among India's top incubators and accelerators, Forge fuels startup success by providing critical programmatic interventions across the entire lifecycle of industrial tech ventures to ensure that its startups win at every stage, by offering critical strategic advisory, market access pathways to industrial companies, product acceleration & access to tech infrastructure, industrialisation & commercialisation partnerships, as well as investment pathways. https://bit.ly/3QTOlD8 Ministry of Health and Family Welfare, Government of India | IITMs HTIC MedTech Incubator | IIT Madras Research Park (IITMRP) | PlebC Innovations Private Limited | Yali Mobility | ABHAYA INFORMATION TECHNOLOGY LLP | Blackfrog Technologies | Ai Health Highway | Aindra Systems | Vish Sahasranamam | Dr. B.L.Lakshmi Meera | Dr. Mahesh Veezhinathan | Dinesh Subburaj | Arun Suresh | Viswanath Srinivasan

"A revolution is brewing in the Biopharma and Medical Devices Market in Miami. Can a single startup truly redefine this complex industry? We believe so! 🚀💡 Meet Miami MediCos, a pioneer in the healthcare sector, providing business support for Biopharma, medical devices, and services companies. Under the bold leadership of Kevin Slawin, Miami MediCos aims to accelerate the commercialization of medical devices, software, services, biologicals, and pharmaceuticals. This ambitious startup isn't just changing the game, it's reshaping the entire ecosystem of healthcare and biotech, creating a ripple effect of innovation and growth. Want to see how they're doing it? Find out by reading our latest feature here: https://lnkd.in/euWzHhvM Spoiler alert: You're about to witness a startup ecosystem unlike any other." #Startup #Innovation #Biopharma #MedicalDevices #MiamiStartups Remember to follow Miami MediCos on LinkedIn for more updates: https://lnkd.in/eu4KPuXz

In the second half of the year, venture capital funding for medtech companies increased to $2.8 billion, up from the first quarter’s $2.5 billion, according to a report published from PitchBook. Still, the modest uptick represents a slow return to a more normalized level of funding for the rest of 2023. Read more: https://lnkd.in/gSjGAXy7 #funding #investmentopportunities #investmentstrategy #investmentresearch #biotechinvesting #medtechinvesting #financialtimes #investing #financeandeconomy #capitalraising #businessandmanagement #capital #startupstrategies #biopharma #biopharmaceuticals #pharma #technology #biopharmaceuticals #biopharma #investment #innovation #innovationinhealthcare #mna #mergersandacquisitions  #biology #startup #diagnostics #diagnostictesting #medicaldevices #medicaldevice #digitisation #digitaltransformation #digitalhealth #digitalcare #vaccination #medicaldeviceinnovation #medical #healthtech #wereabletechnology #futureofhealthcare #digitalhealth #breatcancerawareness #imagingtechnologies #imaging #medtech #artificialintelligence #ai #cancerresearch #cancertreatment #digitaltherapeutics #digitalhealth #healthtech #sustainability #sustainabilityinhealthcare #healthcareinnovation

US$7 Mln Funding Two of the biggest challenges facing healthcare R&D are the sheer volume of data and the unique characteristics of every person’s health. To manufacture a drug is a complex, costly and uncertain process, often taking many years with no guarantee of success. However, AI for drug development is rapidly streamlining the processes, speeding up time to market and providing a better experience for patients and providers. AI has been utilized for some time now in the pharmacy setting, but it has evolved significantly in recent years. So much so that pharmacies can better predict drug effectiveness, identify potential side effects, quicken time-to-market for emerging medications and even design new drugs. NICHE TO MAINSTREAM The pharmaceuticals and life sciences industry has been very cautious in applying digital technology to improve manufacturing and supply chain operations thus far, yet that caution is becoming a hindrance. Large pharma companies typically have the bandwidth required to embrace new digital solutions. However, SMBs manufacturers often lack the means to pursue those same objectives. As the pharma industry faces growing challenges including globalization, great supply chain complexity, price and cost pressure, and personalized medicine, among others digitization holds tremendous potential in helping companies adapt. It has created a massive market opportunity for startups offering solutions in the sector. One of the startups is Leucine. Leucine is a digitalized pharmaceutical manufacturing company, founded by Vivek Gera, and Mustaq Singh Bijral. Leucine is at the forefront of digitizing pharmaceutical manufacturing, leveraging AI technologies to bring efficiency and compliance to the shop floor. Its solutions, from Batch Planning to Batch Release, aim to optimize traditional procedures, replacing paper-based records with a digital-first approach. Leucine streamlines the manufacturing process and delivers actionable insights through its AI-driven analytics dashboard, empowering pharma companies to produce safer and more effective medicines. The company's AI framework is designed to serve as a co-pilot in pharmaceutical manufacturing processes. Built on proprietary LLM technology, Leucine10x’ AI co-pilots perform specialized tasks such as digitizing paper-based SOPs, creating a digital twin of the shop floor, collaborating with Production Managers in creating dynamic production plans, thus ensuring on-time batch delivery. Leucine has raised $7 million funding. The company intends to use the funds to refine its AI capabilities to make its AI Co-pilot a partner to production and quality managers on the shop floor, and expand its reach to more facilities and customers. #funding #ai #pharma #manufacturing #startup #analytics #platform #vc

Bertelsmann Investments is investing several million euros in Tel Aviv-based QuantHealth, an AI-powered healthcare startup for planning clinical trials.   More than 90 percent of the drugs that make it to the clinical trial stage never reach the market. The cost of these trials is estimated to be around $50 billion. QuantHealth uses artificial intelligence to simulate hundreds of trials and trial designs to significantly increase a trial’s chance of success and speed up its execution. Based on 350 million patient records, QuantHealth can predict study outcomes with 86 percent accuracy.   Carsten Coesfeld, CEO of Bertelsmann Investments, says: “The QuantHealth team led by co-founder and CEO Orr Inbar recognized very early on what great potential Artificial Intelligence holds for the BioPharma industry. The services QuantHealth provides are unique. I am very pleased that we are contributing to the further development of QuantHealth with our investment.”   Orr Inbar, co-founder and CEO of QuantHealth, stated: “According to a recent Deloitte article, ROI on pharma R&D has steadily declined, reaching 1.2 percent in 2022, the lowest the industry has seen in decades. This decline is happening at a time when the need for efficient drug development has never been greater. We firmly believe that deep AI solutions like ours will dramatically enhance the success of clinical trials, and pave the way towards better and cheaper therapies for patients around the world.”   QuantHealth was able to raise a total of 15 million US dollars in the current round of financing. Bertelsmann Investments and Pitango HealthTech co-led the financing round. Existing investors include Nina Capital, Shoni Top Ventures, Boston Millennia Partners, Atooro Fund, and Renegade Ventures.   Thorsten Wirkes, Senior Vice President at Bertelsmann Investments, commented: “We are very pleased to co-invest in QuantHealth alongside Pitango and to further expand our growth unit Bertelsmann Next with an investment focus on Digital Health. The impressive AI technologies of QuantHealth have proven to save pharmaceutical companies millions, helping them bring drugs to market quicker and get patients the treatments they need.”   Within Bertelsmann Investments, the Bertelsmann Next unit focuses its investments on the fast-growing Digital Health, Mobile Gaming, and HR Tech sectors. Since Next was launched in mid-2022, €70 million has already been invested in the field of digital health. Further investments are to follow.  

Founded in 2019 by visionary Kolli Sarath, Boltzmann Labs is transforming the landscape of drug discovery and clinical trials with the power of Generative AI. This Bengaluru-based startup leverages both open-source and proprietary models to design novel drugs and optimize R&D processes for Indian drug manufacturers. Boltzmann's innovative approach has led to the development of a robust technology stack, comprising four advanced platforms dedicated to enhancing clinical trials, disease diagnosis, and the design and discovery of vaccines and antibodies. This cutting-edge technology is setting new standards in the industry, improving success rates and reducing the time and cost associated with drug development. Supported by AngelList India, Boltzmann has secured $200K in funding since its inception. This financial backing has enabled the startup to scale its operations and continue its pioneering work in the field of drug discovery. Despite being a relatively young company, Boltzmann stands shoulder-to-shoulder with global giants like Insilico Medicine, Recursion AI, and Exscientia, demonstrating the potential and capability of Indian startups on the global stage. Boltzmann’s success story is a testament to the power of innovative thinking and the application of advanced technologies in solving real-world problems. As the company continues to grow and innovate, it is set to make significant contributions to the pharmaceutical industry, not just in India but worldwide. This strategic application of Generative AI is not only enhancing the efficiency of drug development but also paving the way for more effective treatments and cures. Boltzmann's journey is an inspiring example of how technology and entrepreneurship can come together to create impactful solutions that address some of the most pressing challenges in healthcare today. As Boltzmann continues to innovate and push the boundaries of what is possible, it serves as a beacon of progress and a catalyst for change in the pharmaceutical industry. The company's dedication to leveraging cutting-edge technology for the betterment of society is truly commendable and sets a high standard for other startups to follow. Join us in celebrating Boltzmann’s remarkable achievements and stay tuned for more updates on #Startups #Innovation #HealthcareRevolution #PharmaTech #GenAIRevolution #DrugDiscovery #GenAI #PharmaceuticalInnovation #BiotechStartup #ClinicalTrials #AIinHealthcare #HealthTech #StartupSuccess #Boltzmann #TechForGood #InnovationInMedicine #Entrepreneurship #BengaluruStartups #FutureOfHealthcare

Good news for Indian #Medtech #Startups 👏🇮🇳 Convergence of #regulatory practices between various countries and #India for #medicaldevices and #drugs was the need of the hour as it would ensure companies, irrespective of their geographies, produce highly compliant devices worthy of export. Approval of the Memorandum of Intent ( MoI) between #Netherlands and #India by Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India is a great step in this direction. Such convergence would ensure #Startups and #medtech companies manufacture medical devices and drugs with highest international quality standards in #India, worthy of exports. Complete article and Credits: https://lnkd.in/gfe2qBTJ PHEEZEE - Startoon Labs Pvt. Ltd, India Tagging supporters of Startoon Labs Pvt. Ltd, India : IKP Knowledge Park, T-Hub, IKP EDEN, WE Hub, A Government of Telangana Initiative, Research and Innovation Circle of Hyderabad (RICH), Telangana State Innovation Cell - Office of the Principal Scientific Adviser to the Government of India, Atal Incubation Centre - CCMB, AIC T-Hub Foundation, Ministry of Electronics and Information TechnologyMinistry of Micro, Small and Medium Enterprises, Government of India, Department Of Biotechnology, Government Of india, Ministry of Science and Technology - Government of India Official, Biotechnology Industry Research Assistance Council (BIRAC)- Government of India, MeitY Startup Hub, DBT BIRAC, Cogniphy - USA, Guptaji invests, Telangana Lifesciences Startup India Government of Telangana, Government of India Official Indian Institute of Technology, Madras Indian Institute of Management, Calcutta

Biopharma R&D faces challenges such as low productivity, high failure rates, and lengthy development timelines. However, the emergence of Digital Health tools in biopharma research is transforming this landscape by enabling biopharma companies to identify novel drug targets, optimize drug properties, and predict efficacy more accurately. These technologies accelerate drug development, reduce costs, and hasten therapeutics to market. They also improve clinical trial design, cut patient recruitment time, and enhance patient stratification. The integration of Digital Health tools is poised to transform the R&D landscape, addressing long standing productivity challenges. The data from the “Algorithms to Cure: How Biopharma is Redefining Innovation with AI” report highlights the pivotal role of funding, AI, and partnerships in the industry. From 2018 to 2023, the number of partnerships between biopharma and Digital Health ventures has grown by an impressive 3.9x, with Roche leading the pack with 44 announced partnerships. Across the Research Solutions domain, 76% of ventures are using AI technology, demonstrating the ability to reduce drug discovery timelines from 3-6 years to an average of 17 months. The Digital Health ecosystem has matured beyond prototypes and proof-of-concept stages, with 44% of ventures having proven Clinical Strength. However, financial pressure remains high across the ecosystem, with cumulative Digital Health venture funding worldwide closing at $22.0B in 2023, down 37% compared to 2022. Venture funding in Research Solutions tumbled 35% over 2023 to close the year at $3.9B, with 76% of capital deployed to ventures founded in North America. The integration of Biopharma R&D Digital Health tools marks a transformative shift, empowering biopharma firms to harness big data, AI, and GenAI, catalyzed by partnerships with Digital Health ventures. This collaboration enhances research productivity and elevates patient outcomes. #pharmaResearch #artificialintelligence #GenerativeAI #digitaltech #digitalhealth #digitalhealthventures

💊 Ensuring new pharmaceuticals reach the market quickly can mean saving lives, but old-school paper-based compliance systems often slow things down, as well as leave room for errors. How is Leucine using AI to help bring drugs to market quickly and safely? The startup's AI-powered platform acts as a digital twin of the pharma manufacturing shopfloor, automatically generating digital records and providing essential insights into potentially compliance-compromising issues and their root causes. The technology helps to streamline processes, as well as flag any issues so they can be dealt with quickly before they have a much greater impact further down the line. #pharma #AI #digitaltwin #startup #innovation #health

Panna Sharma, CEO of Lantern Pharma (NASDAQ: LTRN) “The deals that will be made will be in fairly late-stage assets and programs, with #pharma companies potentially reaching into earlier programs around areas like #GLP1 and #obesity and perhaps in certain antibody-drug conjugates #ADC #technologies. While I see greater reward going to companies with later-stage clinical programs, it will have the dampening effect of fewer #collaborations and co-developments for earlier-stage companies. This economic reality is being faced by many #biopharma companies and will push them to find newer, faster, and less expensive ways to show meaningful progress in their programs – the most notable method of which is wide-scale adoption of #AI technologies to hasten and sharpen earlier stage programs,”