Delhi, India
7K followers
500+ connections
7K followers
500+ connections
About
I believe the future of healthcare lies where innovation meets intention.
With…
With…
Articles by Dr. Ashwini
Activity
7K followers
-
Dr. Ashwini Kumar shared thisEntering India’s healthcare market is often seen as a commercial opportunity. In reality, it is equally a regulatory strategy exercise. For global medical device manufacturers, one of the biggest misconceptions is that Central Drugs Standard Control Organization (CDSCO) import licensing is only about filing the right form. It is not. Correct device classification, selecting the right authorised agent, understanding whether the product is treated as a predicate or new device, and aligning documentation with Indian regulatory expectations, all of these significantly influence timelines and long-term market entry success. As India’s MedTech ecosystem continues to mature under MDR 2017 and evolving CDSCO frameworks, regulatory preparedness is becoming a competitive advantage, not just a compliance requirement. This article by the CliniExperts Services Pvt. Ltd. team breaks down the CDSCO import licensing process in a simplified and structured manner for global manufacturers looking to enter India responsibly and efficiently. A useful read for MedTech founders, regulatory teams, global OEMs, and healthcare businesses evaluating India market entry. Read the article here #MedicalDevices #CDSCO #RegulatoryAffairs #MedTech #HealthcareInnovationDr. Ashwini Kumar shared thisIndia continues to be one of the most attractive markets for global Medical Device companies, driven by its growing healthcare sector and vast opportunities. However, entering the Indian market requires careful regulatory planning under CDSCO and the Medical Devices Rules, 2017. From correct device classification and appointment of an authorized Indian agent to choosing the right MD forms and SUGAM submission pathway, every step plays a critical role in ensuring smooth market entry and regulatory compliance. Read the full article now on our website: https://lnkd.in/gvwQeRZK #MedicalDevices #CDSCO #MedicalDeviceRegulations #IndiaMarket #HealthcareIndustry #RegulatoryCompliance #CliniExpertsHow to Get a CDSCO Import License in India: A Step-by-Step Guide for Foreign Medical Device CompaniesHow to Get a CDSCO Import License in India: A Step-by-Step Guide for Foreign Medical Device Companies
-
Dr. Ashwini Kumar posted thisHow do you convince your first client… when you have no clients to show? This is a question many founders in service businesses eventually face. I faced it early on. When I started CliniExperts Services Pvt. Ltd., there was no portfolio. No case studies. No track record as a company. And in a domain like pharma, medtech, and biotech, that gap matters. Because here, decisions are not just commercial. They are built on trust, compliance, and accountability. Most organisations prefer partners who have already done it before. So the question becomes: Why would someone choose you… when you haven’t worked with a single client yet? My first breakthrough came with Johnson & Johnson. The only reason being: we had clarity in how we approached the problem they were trying to solve back then. At that time, GCP audits were largely conducted through a standard lens, focused on documentation, processes, and compliance checkpoints. We introduced a completely different perspective. Being a doctor, I looked beyond the documentation. I evaluated how clinical investigators were actually following protocols in real-world practice. Not just what was recorded,but how it was being executed. This was not a commonly practiced approach at the time. It brought together: • Clinical understanding • Regulatory expectations • Real-world execution insight In many ways, it redefined how GCP audits could be approached. What we offered was not just a service; It was a deeper layer of domain expertise. More structured. More contextual. More aligned with how regulators and outcomes intersect. That shift made the difference. At the same time, my background, an MD from All India Institute of Medical Sciences, helped build initial credibility. But degrees alone don’t win trust. Execution does. Conviction does. Clarity does. Looking back, I realise something important. Your first client may or may not come because of your past. It comes from how clearly you can define a better way forward. Because in the absence of experience, people don’t buy proof. They buy belief. And that belief is built in how you think, how you communicate, and how responsibly you approach the work. Winning that first project was not just a milestone. It was a responsibility to justify the trust placed before any track record existed. If you reflect on your own journey: What helped you win trust… before you had results to show? #Entrepreneurship #Leadership #StartupJourney #B2B #BuildingTrust
-
Dr. Ashwini Kumar shared thisYour AI medical device just became smarter. Do you need to go back to the regulator every single time it improves? Traditionally, the answer was yes. And that created a major challenge for AI in healthcare. Because unlike traditional medical devices, AI systems are not static. They learn from new data. They improve performance. They adapt over time. But under older regulatory models, even meaningful improvements to an AI-driven medical device could require a completely new submission and review process. Which meant innovation often moved faster than regulation. The US FDA ’s Predetermined Change Control Plan (PCCP), finalised in December 2024, attempts to solve this problem in a very practical way. The idea is surprisingly simple. Before an AI medical device is approved, the company explains to the regulator: • What kinds of future algorithm updates may happen • How those changes will be tested and validated • What safeguards will ensure the AI remains safe and effective If the regulator approves that framework in advance, certain improvements can later be implemented without restarting the entire approval process each time. In simple terms: Instead of asking for permission after every improvement, you agree upfront on how improvements will happen responsibly. That changes the conversation completely. Because PCCP is not just about speed. It is about creating a system where: • Innovation remains accountable • Regulators maintain oversight • Patients benefit from continuously improving technology This is one of the first major regulatory frameworks designed specifically for adaptive AI systems, not static software. And it signals something larger: Healthcare regulation is beginning to evolve alongside intelligent technologies, rather than reacting years later. The concept is now live in the US. Europe is moving in a similar direction through parts of the AI Act. The larger question now is: How should other regulatory ecosystems including India’s Central Drugs Standard Control Organization(CDSCO) prepare for continuously learning medical AI systems? CliniExperts Services Pvt. Ltd. CliniExperts Research Services #AIinHealthcare #SaMD #RegulatoryAffairs #MedTech #DigitalHealth
-
Dr. Ashwini Kumar shared thisHow does a regulatory ecosystem evolve - quietly, but consistently? India’s medtech regulatory journey over the last decade tells a story that is often under-discussed. In 2017, the introduction of the Medical Devices Rules (MDR) fundamentally changed how devices were regulated in India. It was not just a policy update. It was a structural shift. A move toward: • Risk-based classification (Class A–D) • Defined licensing pathways • Alignment with global regulatory principles In fact, MDR 2017 introduced a comprehensive framework covering classification, manufacturing, import, clinical evaluation, and post-market surveillance, bringing India closer to global regulatory standards And the evolution did not stop there. Over the years, Central Drugs Standard Control Organization(CDSCO) has continued to build on this foundation: • Expansion of notified devices • Digitalization of approvals (SUGAM portal) • Strengthening of post-market oversight And now, with the 2025 draft guidance on medical device software, we are seeing the next phase. A system that now: • Clearly distinguishes between SiMD and SaMD • Introduces structured pathways for software-driven healthcare • Emphasizes quality systems, lifecycle management, and post-market monitoring This is not a sudden leap. It is a layered progression. From regulating devices… to regulating systems… to now regulating intelligent, adaptive technologies. What stands out is not just the pace of change. But the intent. A gradual shift from: Reactive oversight to Structured, forward-looking regulation And that is what builds credibility at a global level. Because strong industries are not built only on innovation. They are built on regulatory systems that evolve with it. Having worked closely with this ecosystem, one thing becomes clear: India is no longer just aligning with global frameworks. It is beginning to define its own. What, in your view, has been the most defining shift in India’s medtech regulatory journey so far? CliniExperts Services Pvt. Ltd. CliniExperts Research Services #MedTech #RegulatoryAffairs #HealthcarePolicy #DigitalHealth #IndiaHealthcare
-
Dr. Ashwini Kumar shared thisWhat if cancer could be detected before it even shows symptoms? In one of our recent conversations with Dr. Gurdeep S. Sethi M.D., we explored a fascinating advancement in early cancer detection - PanTum Detect, a simple blood test designed to identify tumors at a very early stage. What makes this approach interesting is not just the idea of early detection, but how it works. Instead of looking for tumors directly, the test leverages the body’s own biology, specifically macrophages, the immune system’s “scavenger cells.” These cells constantly circulate in the blood, picking up abnormal proteins from anywhere in the body, whether from infections or potentially from tumor activity. Using a patented EDIM (Epitope Detection in Macrophages) technology, this test analyzes what these macrophages have “collected,” offering a window into what may be happening inside the body, often before clinical symptoms appear. The potential here is significant: • Detecting cancer at Stage 0, 1, or 2 - where intervention can be far more effective • Moving from reactive diagnosis to proactive screening • Leveraging the immune system itself as a diagnostic tool Of course, like any emerging diagnostic innovation, parameters such as sensitivity, specificity, and clinical validation across populations will continue to define its real-world impact. But the direction is clear. The future of oncology may not just depend on better treatments, but on how early, how accurately, and how intelligently we can detect disease. Would you trust a simple blood test to tell you what your body hasn’t yet felt? CliniExperts Research Services CliniExperts Services Pvt. Ltd. #MedTech #Oncology #EarlyDetection #HealthcareInnovation #Diagnostics #ClinicalResearch
-
Dr. Ashwini Kumar reposted thisDr. Ashwini Kumar reposted thisHiring ERPNext / Frappe Developers with 4–5 years of experience to build and scale impactful solutions in the CRO space. If you’re passionate about Python, automation, and creating systems that matter — we’d love to connect. #Hiring #ERPNext #Frappe #PythonJobs #TechHiring #DelhiJobs #CliniExperts
-
Dr. Ashwini Kumar shared thisSiMD, SaMD, or an AI healthcare tool - are we classifying correctly, or assuming? In India’s evolving digital health landscape, this distinction is not just technical. It is regulatory. And getting it wrong does not lead to a small correction. It can impact your entire pathway - approvals, timelines, and in some cases, your licence to operate. I’ve seen this pattern often. A product is built with strong intent and solid technology. But somewhere along the way, classification is treated as a late-stage decision. Something to address after development. In reality, classification should be one of the earliest strategic decisions. Because it influences: • The regulatory pathway you follow • The level of evidence required • The documentation and validation approach • The time it takes to reach the market The challenge is that many digital health solutions today sit in grey areas. Is it: • Software in a Medical Device (SiMD)? • Software as a Medical Device (SaMD)? • Or an AI-enabled healthcare tool with clinical implications? The answer depends not on the technology itself, but on its intended use, risk profile, and impact on clinical decision-making. Regulation does not evaluate innovation. It evaluates responsibility. And clarity at the start often prevents complexity later. If you are building or deploying digital health solutions in India: At what stage do you believe classification should be finalised - early in development, or closer to defining regulatory strategy? CliniExperts Services Pvt. Ltd. CliniExperts Research Services #SaMD #SiMD #AI #healthcare #medtech
-
Dr. Ashwini Kumar shared thisWhat if your regulatory function operated like a full-fledged department, without the complexity of building one in-house? Across healthcare, pharma, MedTech, and nutraceutical businesses, I’ve observed a recurring gap: Regulatory affairs is often treated as a support function. Not as a strategic system. But today, navigating bodies like Central Drugs Standard Control Organization and Food Safety And Standards Authority Of India (Fssai) requires continuous alignment, not episodic intervention. Which is why we’re introducing something we’ve been thoughtfully building: CliniExperts Services Pvt. Ltd.’ Outsourced Regulatory Affairs Department A model designed to function not as an external vendor, but as an extended regulatory arm of your organization, bringing together multi-regulatory expertise, structured processes, and execution clarity within one integrated system. Because compliance today is not just about approvals. It’s about speed, predictability, and confidence in every decision you make. If you're building or scaling in a regulated environment, the real question is no longer whether you need regulatory support; but how strategically it is embedded into your growth journey. If you’re rethinking how regulatory can move from a bottleneck to a business enabler, I’d be glad to exchange perspectives. https://lnkd.in/gngeG9Q8 #RegulatoryAffairs #MedTech #HealthcareCompliance #DigitalHealth #HealthcareConsultingYour outsourced regulatory affairs department — CDSCO, FSSAI & cross-functional compliance, Always…Your outsourced regulatory affairs department — CDSCO, FSSAI & cross-functional compliance, Always…
Dr. Ashwini Kumar replied to a comment
1w
Very true, Patatri.
In oncology, time often becomes one of the most critical determinants of outcome. Early diagnosis not only improves treatment pathways, but also expands the window for informed clinical decision-making.
Technology, AI, and innovation become far more meaningful when they help enable that earlier intervention responsibly and at scale.
Dr. Ashwini Kumar replied to a comment
1w
Very thoughtfully articulated, Patatri.
The core intent remains the same, understanding problems deeply and responding with responsibility. The only thing that changes is the scale of impact.
Clinical practice teaches you to understand individuals.
Entrepreneurship teaches you to understand systems.
Both, in many ways, begin with observation, empathy, and trust.
Dr. Ashwini Kumar replied to a comment
1w
Well said, C. Padmakumar.
The real challenge with AI-driven healthcare systems is not just technological capability, but ensuring that innovation, validation, and clinical integration evolve together.
Long-term trust in these systems will depend on how responsibly that balance is maintained in real-world practice.
-
Dr. Ashwini Kumar liked thisDr. Ashwini Kumar liked thisEntrepreneurship often begins with hustle, ambition, and the belief that success comes from doing it all yourself — but the most sustainable growth often comes when you learn to let go. In her latest reflection, WIN Executive Director Rebecca Takemoto shares how motherhood transformed the way she leads, builds teams, embraces imperfection, and navigates the many seasons of entrepreneurship. From letting go of perfection, to trusting others, to learning that grace, resilience, and adaptability may be the most important leadership skills of all — this is a deeply honest reflection on growth. Not just as a leader, but as a woman navigating ambition, family, identity, and purpose. And most importantly, a reminder that every woman’s story deserves to be honored, whether motherhood is part of that story or not. Read Rebecca’s full blog post: https://lnkd.in/gZaycZY4 Karen E. Todd, MBA, RD Heather Granato Michelle Martin Karen Howard Doug Reader Jan Mills Anand Swaroop Dr. Sybille Buchwald-Werner Crystal Webber, MS, RD Petra Erlandson Ewa Hudson #WomenInNutraceuticals #WINtogether #Leadership #Entrepreneurship #WomenInBusiness #Motherhood #LeadershipLessons #WomenLeaders #Community #PersonalGrowth
-
Dr. Ashwini Kumar liked this“Great teams don’t just achieve milestones—they build movements that create lasting impact.” Truly proud to see this recognition for a journey that has meant so much to all of us. Special appreciation to the entire Vaccines team at Pfizer India for bringing this vision to life with such commitment and heart. Moments like these reinforce why we do what we do—building something that goes beyond a launch to create lasting change. #PfizerProud #OPPIAnnualAwards #AdultImmunizationDr. Ashwini Kumar liked thisA proud leadership moment for Vaccines Medical, Pfizer India. Honoured to receive the Runner‑Up recognition at the OPPI Medical Excellence Awards 2025–26 for “Launch Excellence to Public Health Impact: Strengthening India’s Adult Immunisation Ecosystem”. This achievement reflects consistent leadership commitment to science‑driven decision‑making, responsible innovation, and long‑term public health value. Especially meaningful as this marks our second OPPI Medical Excellence recognition in succession—a testament to sustained excellence. A special note of thanks to Dr Santosh Taur, MD, DM, CMD for his visionary leadership and for championing science‑led, patient‑centric impact in adult immunization. Deep appreciation to Meenakshi Nevatia, Amit Agarwal, Dr. Pankaj Gupta, Nilesh Pendse, Manikantan Seshadrinathan, Sharad Goswami, Saral Gupta, Dr.Seema Pai, Manish Paliwal and the Leadership Team at Pfizer India for their strategic direction, trust, and unwavering support. Grateful to the India Vaccines team - Dr Mukundraj Keny, Dr. Sachin Choudhari, Dr Abhishek Tripathi, Arshiya Sehgal MD, Dr Joseph Immanuel, Anusha Gupta, MDS, Dr. Vishal Mitkari, Dr Praveenkumar Rajendran M.D., Dr. Gitika Jha, Dr. Durgesh Nandini, Rajashekhar Arra, Dr. Rashi Jaiswal, Sairam R R, Amol Dhiman, Jitender Sharma, Parth Mishra, Jacob Anand, Uma Balakrishnan, Dr Anuja Giri, Murtuza Stationwala and our cross‑functional partners across Regulatory, Clinical, Access, Policy—this OPPI recognition is truly a team win. Heartfelt thanks to Egemen Ozbilgili, MD, Mark Fletcher, and Bulent Taysi for their continued guidance, and global leadership. Proud of the journey. Focused on what’s next. #PFEColleague #OPPIMedicalExcellence #OPPIAnnualDay #PowerofPartnership #OPPIAnnualAwards #AdultImmunisation #PublicHealthImpact #MedicalLeadership
-
Dr. Ashwini Kumar liked thisDr. Ashwini Kumar liked thisHappening tomorrow! FDA will be taking industry questions on a proposed pilot program to assess how AI-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. Register here: https://lnkd.in/ey-SRQ8X
-
Dr. Ashwini Kumar liked thisDr. Ashwini Kumar liked thisIndia continues to be one of the most attractive markets for global Medical Device companies, driven by its growing healthcare sector and vast opportunities. However, entering the Indian market requires careful regulatory planning under CDSCO and the Medical Devices Rules, 2017. From correct device classification and appointment of an authorized Indian agent to choosing the right MD forms and SUGAM submission pathway, every step plays a critical role in ensuring smooth market entry and regulatory compliance. Read the full article now on our website: https://lnkd.in/gvwQeRZK #MedicalDevices #CDSCO #MedicalDeviceRegulations #IndiaMarket #HealthcareIndustry #RegulatoryCompliance #CliniExpertsHow to Get a CDSCO Import License in India: A Step-by-Step Guide for Foreign Medical Device CompaniesHow to Get a CDSCO Import License in India: A Step-by-Step Guide for Foreign Medical Device Companies
-
Dr. Ashwini Kumar liked thisDr. Ashwini Kumar liked thisThe new augmentOR™ Portal makes collaboration smarter than ever with upgraded video editing and sharing features that help teams review cases more efficiently, highlight key moments, and capture insights in real time. Now available on both iPhone and Android, clinicians can use the Portal to access Performance‑Guided Surgery™ wherever they are, bringing greater flexibility and connectivity to the surgical workflow.
-
Dr. Ashwini Kumar liked thisDr. Ashwini Kumar liked this𝗣𝗖𝗢𝗦 𝗷𝘂𝘀𝘁 𝗯𝗲𝗰𝗮𝗺𝗲 𝗣𝗠𝗢𝗦. 𝗔𝗳𝘁𝗲𝗿 𝟭𝟰 𝘆𝗲𝗮𝗿𝘀 𝗮𝗻𝗱 𝟭𝟰,𝟯𝟲𝟬 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗮𝗻𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗶𝗮𝗻 𝘀𝘂𝗿𝘃𝗲𝘆 𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗲𝘀, 𝘁𝗵𝗲 𝗿𝗲𝗻𝗮𝗺𝗲 𝗶𝘀 𝗼𝗳𝗳𝗶𝗰𝗶𝗮𝗹. The Lancet published the global consensus paper yesterday, with parallel announcement at the European Congress of Endocrinology in Prague. The new name, polyendocrine metabolic ovarian syndrome, replaces a term that was based on a 1930s surgical observation that turned out to be wrong. PMOS patients do not have pathological cysts. They have a population of follicles that fail to mature. 𝗪𝗵𝘆 𝘁𝗵𝗶𝘀 𝗺𝗮𝘁𝘁𝗲𝗿𝘀. The condition affects 1 in 8 women globally (more than 170 million people). Up to 70 percent of cases remain undiagnosed, in part because the gynecologic framing obscured the metabolic, endocrine, dermatologic, and psychological reality of the disease. The NIH first recommended a rename in 2012. It took international leadership led by Helena Teede AM at International Society of Endocrinology - ISE, a democratic Delphi process across 56 partner organizations, and direct patient advocacy involvement to make it stick. Women living with the condition were the drivers of change. Their advocacy, leadership, and lived experience shaped this outcome. For those of us who have spent more than a decade in this space (Chemical Resources (CHERESO) & Cepham Inc Furocyst® program began clinical work on PCOS in 2012 with a 208-subject randomized controlled trial), the rename is overdue scientific honesty. The condition was always insulin resistance, androgen dysregulation, and chronic low-grade inflammation, with reproductive consequences as one expression of a multi-system endocrine syndrome. 𝗣𝗠𝗢𝗦 𝗿𝗲𝗳𝗹𝗲𝗰𝘁𝘀 𝗮 𝘄𝗵𝗼𝗹𝗲-𝗯𝗼𝗱𝘆 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻, 𝗻𝗼𝘁 𝗷𝘂𝘀𝘁 𝘁𝗵𝗲 𝗼𝘃𝗮𝗿𝘆. For nutraceutical R&D, the rename has three implications: [1] Shift in formulation logic from PMOS as a fertility problem to metabolic-endocrine disorder with fertility, dermatologic, and psychological consequences. [2] Boader clinical endpoint selection: HOMA-IR, lipid panels, dermatologic scores, and validated QoL instruments belong alongside cycle regularity. [3] Claims framing has to follow the science. 𝗔 𝗻𝗼𝘁𝗲 𝗼𝗻 𝗺𝗮𝗹𝗲 𝗣𝗠𝗢𝗦. Emerging work suggests a male equivalent of the syndrome exists, particularly in first-degree male relatives of affected women. Insulin resistance, central adiposity, dyslipidemia, and early-onset androgenetic alopecia are the typical cluster. The shared genetic and metabolic architecture is real, even if the male phenotype remains less well characterized. STAT on the male form: https://lnkd.in/ehYRvuGS The Lancet consensus paper: https://lnkd.in/e5ezQ5v6 Pawan Kumar Sameer Joshi Christopher Lamb #WomensHealth #Endocrinology #PMOS #ClinicalResearch #NutraceuticalsPolyendocrine metabolic ovarian syndrome, the new name for polycystic ovary syndrome: a multistep global consensus processPolyendocrine metabolic ovarian syndrome, the new name for polycystic ovary syndrome: a multistep global consensus process
-
Dr. Ashwini Kumar liked thisDr. Ashwini Kumar liked thisOne of the questions I get asked most often in fetal cardiology is: What does a prolonged fetal PR interval mean? The honest answer is, before we discuss what it means, we need to talk about whether the number we have is reliable. I have written a detailed acquisition guide covering the three main pulsed-wave Doppler methods for measuring the fetal mechanical PR interval: LV inflow/outflow, SVC/ascending aorta, and pulmonary artery/vein, along with tissue Doppler as a supplementary technique. The post covers: → Which fetal position each method requires → Angle of insonation, wall filter, sweep speed → Why PA/PV values run 6–15 ms higher than MV/Ao across gestation → Why SVC/Ao and MV/Ao give broadly similar values — and when that matters → When mPR measurement is actually indicated All clinical images are from our lab. There is also a free interactive guide linked in the post with normative charts, method bias data, and a full acquisition walkthrough. Read the full post here: https://lnkd.in/gs7XNRtf #FetalCardiology #FetalEchocardiography #PediatricCardiology #CongenitalHeartBlock #NeonatalLupus #FoetalMedicine #FetalArrhythmia #MaternalFetalMedicineMeasuring the Fetal PR Interval: Getting the Acquisition RightMeasuring the Fetal PR Interval: Getting the Acquisition Right
Experience & Education
View Dr. Ashwini’s full experience
See their title, tenure and more.
or
Publications
Recommendations received
2 people have recommended Dr. Ashwini
Join now to viewWebsites
- Company Website
-
http://www.cliniexperts.com/
Other similar profiles
Explore more posts
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More