MEMO-12- September 2026

Three People, Three Regulatory Journeys

You’ve built a new medical device. The hardware is solid, the AI model works, and the team is ready to scale.

Then comes the million-dollar question: “What’s our regulatory strategy?”

The answer depends entirely on who’s asking.

The Founder

Yash doesn’t need a PhD in regulatory compliance, but he can’t fly blind either.

He needs to understand the shape of the journey. What does the product need to be classified as? What claims can it make? What evidence will be required? What needs to happen before the next milestone? What is currently holding things up?

He is paying for the work, and ultimately responsible for the business decision. If regulatory takes three months longer than expected, it is his product launch that moves. If an important requirement is discovered late, it is his budget that absorbs it.

So his regulatory journey is about visibility and decisions.

He needs just enough context to ask sharp questions and keep momentum real.

The QARA Executive

Priya isn’t debating strategy—she’s executing in the trenches.

She doesn’t ask what regulations mean; she makes sure the company complies with them.

Every project/new product lands on her desk as fragmented data from engineering, product, quality, and overseas partners. Her job? Filter the noise, spot inconsistencies, fill the gaps, and build the submission file.

She starts with the product description. Then the intended use. Then classification. Then documentation. Then evidence.

And almost every answer creates another question or three

A missing document, conflicting version histories, an unverified technical claim—she has to reconcile it all while juggling pressure from product managers and founders.

Her manager wants progress. The founder wants visibility. The submission still has to be right.

Hiring external consultants isn’t always a win—it’s often a last resort. If Priya and her internal team can solve it in-house, that’s a massive win for the company.

Her QARA journey is about getting the work done correctly and efficiently.

The Consultant

Jonathan encounters the same kind of product from an entirely different direction.

He is called when a founder does not have the regulatory capability internally, or when the problem has become specialised enough to need outside expertise. The context and mess created not knowledge gaps is his challenge.

Before solving the problem, he has to untangle the client’s existing history.

It is understanding the client. What exactly is the product? What does it claim to do? What has already been decided? What evidence exists? What has the team already submitted or discussed? What does the founder think the pathway is?

But that is only half of it. Jonathan is rarely working with one client at a time. He is working with several, each at a different stage, each with its own history, its own open questions and its own half-finished documents. Reconstructing one client’s story is manageable. Doing it for a dozen clients at once, without letting the quiet ones slip while he is heads-down on the loud one, is a different problem entirely.

So before he can apply any expertise, two jobs run in parallel: rebuild the context for whichever client just came back with a question, and keep track of where every other client currently stands.

Only then can he deliver high-value strategic judgment.

For consultants, it’s about applying specialized expertise at the exact right moment without dropping the ball across a portfolio.

Same Product, Different Journeys

That is the interesting part.

The founder is asking, “Where are we going?”

QARA Executives ask: “What do I need to execute today?”

Consultants ask: “What context do I need to advise effectively right now?”

They are all dealing with regulation, but regulation is not one workflow.

It changes depending on who you are, what responsibility you carry and where you enter the process.

That is easy to miss because we tend to think of compliance as a collection of documents and requirements. But the real work happens between those documents: deciding what applies, gathering the right information, checking it, answering questions, creating the next piece of work and keeping track of why a decision was made — and, for some, doing that across an entire portfolio at once, not just one file.

The lesson is not that founders should become regulatory experts, or that QARA teams should replace consultants or that consultants need to become product engineers.

We need tailored workflows that serve different stakeholders in the regulatory ecosystem.

And perhaps that is the more interesting question for the future of regulatory work: not “How do we put all the information in one place?” but “How do we make the right part of that information useful to the right person, at the right point in their journey — whether they are tracking one product or twelve?”

Grants Spotlight

PRIP Scheme — Second Call — Department of Pharmaceuticals

The most relevant program to this month’s memo, because the novel medical-device track is specifically for devices that have not previously been approved by CDSCO — meaning the regulatory journey described above starts from zero for these applicants, not from a predicate device.

Supports: Early-stage (TRL 1–3, progressing to TRL 5) and later-stage (TRL 4–6) pharma and MedTech projects, including novel medical devices and targeted innovative therapeutics. Funding: Up to ₹5 crore for early-stage projects, up to ₹100 crore for later-stage projects, capped at 35% of approved project cost — the remainder is co-funded by the applicant. Status: Second call announced 28 August 2026. Submission window opens mid-September 2026 on the PRIP portal. Applicants who submitted under Round 1 should not resubmit the same project. Track updates: https://prip.pharma-dept.gov.in/

MedTech Mitra — ICMR, CDSCO & NITI Aayog

Not a grant, but the closest thing to institutional support for the regulatory navigation problem itself — the door a founder, a QARA executive, or a consultant would all use, for different reasons.

Supports: Clinical evaluation guidance, regulatory facilitation, investigator and site matchmaking, expert mentorship. Status: Ongoing, rolling applications, no deadline. Track updates: https://medtechmitra.icmr.org.in/

MAHA MedTech Mission — ANRF / ICMR / Gates Foundation

Worth tracking for founders further along, since regulatory support (via MedTech Mitra) is built into the funding rather than left for the applicant to arrange separately.

Funding: ₹5–25 crore per project, up to ₹50 crore in exceptional cases, milestone-linked, no equity or benefit sharing. Eligibility: TRL-3 or above. DPIIT startups, Udyam MSMEs, academic institutions, hospitals, MedTech companies. Status: First call closed. Two further calls expected across the five-year mission; the second has not yet been scheduled. Track updates: https://anrfonline.in/ANRF/maha_medTech

MEMO-11- AUGUST 2026

Clinical Validation for IVDs, Devices and SaMD: What Counts as Proof

Last month we argued that the AI/ML rules are still being written, and that your product can’t wait for them to settle.The natural next question is what you can decide now, while the rules are still moving. Quite a lot, as it turns out. Because the thing that determines your evidence burden isn’t the rulebook. It’s what kind of product you built — and that is already fixed.

Most founders think clinical validation is about proving their product works. By the time you ask that question, the answer has largely been decided.

Validation doesn’t sit at the end of development. It is the output of everything upstream — intended use, risk classification, materials, electrical safety, software architecture, usability engineering, manufacturing, and the markets you intend to enter. Change any of those late and you don’t adjust your study. You repeat it.

This is where regulation gets misread. Teams treat it as a destination, a checklist to satisfy once the product is built. It is a map. Decades of engineering, clinical and patient safety experience, written down. Read early, it doesn’t only tell you how to get approved. It tells you what evidence your product will eventually have to produce, and therefore how to build it.

Three product types. Three different burdens of proof.

An IVD has to prove the number is true- Analytical validity comes first: precision, linearity, limit of detection, interference, cross-reactivity, stability. Then clinical validity — sensitivity and specificity against a reference standard, in the intended population, with the intended sample types, at the prevalence the test will actually operate in.

The trap is the comparator. A test validated against an imperfect reference inherits that imperfection permanently. And a test validated on a convenience cohort of confirmed positives will look excellent, then fail in screening, where prevalence is a fraction of what you tested in.

A hardware device has to prove it is safe and performs in use- Most of its evidence isn’t clinical at all. Bench performance, biocompatibility, sterilisation validation, electrical safety, EMC, mechanical durability, shelf life. Clinical investigation comes last and answers only what bench testing cannot: does it perform as intended, in real anatomy, in the hands of real users, over the duration it is meant to last.

Change a material or a supplier after that, and you may have invalidated the file your clinical claim rests on.

SaMD has to prove the output holds outside the data it learned from- Performance on a held-out split is not clinical validation. The real questions are generalisability — different scanners, sites, demographics, acquisition protocols — and clinical impact: does the output change decisions, and does that change help.

Ground truth definition, locked versus adaptive algorithms, reader study design, and how clinicians actually behave when shown the output all sit inside the validation strategy, not beside it.

Same word. Three different questions. One playbook cannot answer all three.

Now add geography- If the US is even a possibility, that has to be settled before the first patient is enrolled, not after the last one.

Whether your data can support an FDA submission depends on GCP compliance, investigator qualification, monitoring, data integrity, comparator choice, whether your population is representative of the US intended-use population, and whether your endpoints are ones the agency accepts.

Every one of those is answerable in advance and nearly impossible to retrofit. A completed study that isn’t bridgeable isn’t a head start. It is sunk cost and lost years.

Zoom into India- CDSCO separates two things Western frameworks blur: the licence to make or import samples of your product, and the permission to run the study on humans. The order is fixed. The forms differ by product type.

For a clinical medical device, MD-12 gets you MD-13 — the test licence to manufacture a small quantity for clinical investigation. MD-22 gets you MD-23, permission to conduct the investigation itself. MD-26 gets you MD-27, the new device approval. Only then does the manufacturing licence application begin.

For an IVD the shape is identical, the forms are different. MD-12 to MD-13 for trial batches. MD-24 to MD-25 for permission to conduct the clinical performance evaluation. MD-28 to MD-29 for new IVD approval. Different committee, different evidence standard, different reviewers.

Two traps recur. Pure software IVDs often have no physical batch to manufacture and can skip MD-13, but the CPE permission is not optional. And the retrospective study founders reach for — blinded reads on archived data — is a clinical performance evaluation in CDSCO’s eyes. Run it without MD-25 and the data cannot support the file it was meant to build.

The map isn’t harder than the West’s. It is drawn differently. Read it before the first sample moves.

The second audience- Hospitals are leaving this opportunity on the table.

Sponsors need sites that can run GCP-compliant investigations: trained investigators, an ethics committee that moves, source data that survives audit, documented SOPs, calibration records, and enough continuity that staff turnover doesn’t break a trial.

Institutions that build that capability deliberately become preferred sites — and get early access to technology, research revenue and clinical standing. Those that try to assemble it when a sponsor calls lose the study to someone who was already ready.

What This Really Is- The most successful healthcare companies don’t ask how to satisfy regulation. They ask where they want the product to go, then read backwards to the evidence that route demands.

You decide the route before you get in the car.

Grants Spotlight

MAHA MedTech Mission — Anusandhan National Research Foundation (ANRF) NRF / Indian Council of Medical Research (ICMR) / Gates Foundation India

The most relevant program to this month’s memo, because clinical validation is built into it rather than left to the applicant. Alongside funding, the Mission provides enabling support through MedTech Mitra for regulatory guidance and a Clinical Trial Network for clinical validation and evidence generation.

Notably, hospitals and medical college hospitals are eligible applicants in their own right — not only as sites.

Funding: ₹5–25 crore per project, up to ₹50 crore in exceptional cases, milestone-linked, no equity or benefit sharing Eligibility: TRL-3 or above. DPIIT startups, Udyam MSMEs, academic institutions, hospitals, MedTech companies. Private entities typically contribute 30% cost-share Status: First call closed. Two further calls expected across the five-year mission Track updates: https://anrfonline.in/ANRF/maha_medTech

MedTech Mitra — ICMR, CDSCO & NITI Aayog

Not a grant, and worth being precise about what it is: the application route into clinical evaluation guidance and regulatory facilitation, before a protocol is written. It is also the “apply for support” door on the INTENT network below, which makes it the practical first step rather than a parallel option.

Supports: Clinical evaluation guidance, regulatory facilitation, investigator and site matchmaking, expert mentorship Status: Ongoing, rolling applications — no deadline Track updates: https://medtechmitra.icmr.org.in/

ICMR-INTENT — Indian Clinical Trial and Education Network

This is the one to know if you took anything from this month’s memo. INTENT is the network itself — 81 sites for Phase II/III and four institutions for Phase I, spanning public and private medical colleges, hospitals and research institutes, coordinated by ICMR’s Clinical Studies & Trials Unit.

For founders: ICMR has invited expressions of interest from INTENT centres specifically for collaboration on clinical investigation studies for medical devices and IVDs, and reports eight Make-in-India diagnostics and devices already in its clinical validation pipeline.

For hospitals: this is the concrete version of the argument above. Being in the network is how an institution becomes a site sponsors can actually use. INTENT also runs training and capacity building — its webinar series has covered clinical validation of AI-powered devices, and design validation for devices, IVDs and SaMD specifically.

Status: Ongoing. Phase II/III network operating on an allocated two-year budget cycle (2024–26), so watch for renewal and expansion announcements Track updates: https://intent.icmr.org.in/

A note on timing: none of the three has a dated application window open as of this writing. MedTech Mitra and INTENT accept approaches on a rolling basis. MAHA’s remaining calls have not been scheduled publicly. If your validation strategy depends on any of them, the preparation is what you control — not the calendar.

MEMO-10- JULY 2026

AI/ML Rules Are Still Being Written. Your Products Can’t Wait

Last month we opened up a submission and looked at its anatomy. Intended use, classification, risk, clinical evidence, labelling — one argument, repeated across many documents, that has to agree with itself end to end.

This month we’re looking at a category where that anatomy hasn’t finished forming yet.

AI and ML-based software.

Not because the technology is new. Diagnostic algorithms, triage tools, imaging models — these have been shipping in India for years. But the regulatory frame around them is still being written in real time, and founders building in this category are making decisions inside a gap most of them don’t realise is a gap. Some of those decisions turn out to be about a lot more than compliance.

What Counts as SaMD

Software that sits inside a device — firmware in a monitor, the code driving an infusion pump — inherits the risk class of the hardware it lives in. Nobody argues about that.

The argument starts with software that stands alone. A model that reads a scan, flags a risk score, recommends a triage path, without being embedded in anything. That’s Software as a Medical Device, and in India it has to be classified independently, on its own intended use and clinical impact, same as any other device.

Simple in principle. Founders still get it wrong constantly, because the thing they’re classifying doesn’t hold still.

The CDSCO-FDA Gap

CDSCO released its first real guidance on medical device software only in October 2025. It’s still a draft in parts, still being commented on, still catching up to a category that’s been shipping products for half a decade.

The USFDA, by contrast, has been iterating on this since 2019 — proposed frameworks, action plans, predetermined change control plans, a total product lifecycle approach that treats an AI model as something that keeps evolving after clearance, not something you approve once and forget. Well over a thousand AI-enabled devices have cleared through that system.

That’s the gap. Not a gap in ambition. A gap in how much runway the framework has had to get specific.

Founders who’ve only ever read the FDA playbook assume the same logic transfers. It doesn’t, not cleanly. India’s classification is still built around a static intended-use statement. The FDA’s newer thinking is built around a model that’s expected to change. Those are two different philosophies wearing similar-looking paperwork.

The Algorithm Change Protocol

This is where CDSCO’s draft guidance is trying to close the gap.

The idea: before you ship, you define — in writing, in advance — how your algorithm is allowed to change. What kind of updates are routine. What triggers a fresh review. Get that protocol approved once, and predefined updates can go out without a fresh approval each time.

Get it approved, and approval doesn’t mean the software is signed off forever. It means the process for changing it is signed off. Everything else is still live.

The protocol itself is the paperwork version of a bigger operational question: when do you actually check on the model, and for what. That question doesn’t end once the protocol is filed.

Monitoring Before, During, After

ISO 14971 already asks for a lifecycle view of risk: identify it, control it, evaluate what’s left, feed real-world data back in. Founders building hardware devices know this exists.

For AI/ML, it needs to be read literally, not just formally. Three checkpoints, not one.

Before. Validate the model against a defined dataset. Set the performance range you’re claiming, before you submit.

During. The checkpoint almost everyone skips. Watching the model’s real-world performance while it’s live and, if it’s adaptive, while it’s still learning. Silent drift is the risk here — performance quietly slipping on a subgroup your training data underrepresented, or clinical practice shifting under a model that hasn’t been told.

After. Standard post-market surveillance, still required. But for an adaptive model it has to answer a sharper question: did the last approved change behave the way the protocol said it would.

None of this is a new framework bolted onto risk management. It’s the same ISO 14971 lifecycle every device already goes through. What’s different is that “during” used to be a formality. For AI/ML, it’s where most of the real risk gets generated after the day you clear.

Founders build the “before” file carefully, because that’s what gets reviewed on the way in. Almost nobody builds a “during” one, because nobody’s checking for it yet. That’s not a paperwork gap. It’s a gap in how they’re thinking about their own product’s risk.

Assistive vs Diagnostic

This is the sharper strategic point, and it’s easy to miss entirely.

Not every AI/ML healthcare tool has to be classified as software that diagnoses. Assistive tools — ones that flag, summarise, prioritise, or support a clinician’s decision without making the call themselves — often land in a lower risk class, sometimes on a genuinely lighter path, occasionally close to the exempted categories CDSCO has carved out for low-risk, non-measuring devices.

That’s the faster, cheaper way to a commercial product.

It’s also the weaker way to defend one.

A diagnostic claim, once cleared, is something your assistive competitors can’t legally make, even if their model performs just as well under the hood. SaMD clearance, seen this way, isn’t only a cost. It’s a wall your competitors have to climb too, and most won’t, because most don’t have the documentation discipline or the runway to do it.

Comparing “how fast can we launch” against “how defensible is what we launch” isn’t comparing two versions of the same paperwork. It’s comparing two different businesses.

Neither answer is wrong. But most founders aren’t choosing it on purpose. They’re landing wherever the intended use statement happened to fall, and discovering what kind of company they built only after the fact.

What Founders Get Wrong

Not the accuracy score. Not the FDA clearance they already hold somewhere else. Not the sophistication of the model itself.

The intended use statement, still. Founders classify around what the technology can do, not what they’re claiming it does, for which population, at what point in the care pathway. “Detects abnormalities” and “supports triage for a specific condition” are different products to a regulator, even on identical model weights.

Treating every version as the same submission. A locked model is a different regulatory object than an adaptive one. Founders write one classification file and expect it to cover both states forever.

Assuming a foreign clearance travels. An FDA clearance is evidence. It is not a shortcut. The substantial equivalence argument still has to be built against an Indian classification logic that doesn’t map one-to-one onto the American one.

Treating classification as a compliance question instead of a strategic one. Whether you’re building the assistive version or the diagnostic version isn’t a legal detail to resolve later. It’s a decision about speed versus moat, made whether you notice you’re making it or not.

What This Really Is

Take last month’s seams problem. Add this month’s moving target. Sit them next to the assistive-versus-diagnostic choice, and a pattern shows up.

How you write the intended use line. Whether you monitor “during” or only “before” and “after.” Whether you go assistive or diagnostic. Each of these reads like a regulatory decision.

It isn’t only that.

It’s a decision about what kind of company you are. Fast and undefended, or slower and moated. Reactive to drift, or watching for it on purpose. These aren’t line items in a Device Master File. They’re the shape of the business, usually decided by accident, by whoever wrote the first draft of the intended use statement and moved on.

Most founders don’t get help thinking it through this way. They get help filling in the form.

We’ve spent enough time inside these decisions to see where the real help needs to sit — not a checklist, something that helps you reason through what a given intended use claim actually costs you and buys you, before you’ve committed to it. So this month we started testing exactly that. Early runs are already surfacing tradeoffs — classification paths, moat implications, the kind of thing that used to take a lawyer and a long meeting to see clearly.

It’s not ready to show anyone yet. But it’s no longer just an idea. Comment or DM if you want to see it first.

Grants Spotlight

Biotechnology Ignition Grant (BIG) — BIRAC

India’s flagship early-stage biotech and medtech grant, back open for its next cycle.

Supports: Technical feasibility, prototype development, proof-of-concept validation.

Does not cover: Regulatory submissions, clinical trials, late-stage validation.

Funding: Up to ₹50 lakh (non-dilutive)

Status: Open now. BIG runs two calls a year, opening every January 1 and July 1, with each window staying open for roughly six weeks. Check the portal for the exact closing date.

Track updates: https://birac.nic.in/big.php

DBT-BIRAC Joint Call on Bio-AI — BioE3 Policy (Mūlānkur Hubs)

Adjacent to this month’s theme rather than squarely inside it, but worth flagging given the timing. A joint call supporting AI-linked biomanufacturing hubs under the BioE3 policy.

Supports: Bio-AI infrastructure and hub-building proposals under the biomanufacturing mission.

Status: Deadline extended to 15 July 2026 — closing on the day of this issue.

Track updates: https://www.birac.nic.in/

Genesis by IKP — Deep Science Venture Program

Not a grant, equity-linked, and narrow on stage, but a strong fit if you’re this early. A 12-month program from IKP Knowledge Park for TRL 2-3 startups, with Healthtech & AI as one of four named focus areas this cohort.

Supports: IP strategy, regulatory pathway clarity (including CDSCO), investor readiness, milestone-released funding.

Does not cover: Anything past TRL 3. Not open to OPCs or LLPs — Private Limited only, 51%+ Indian shareholding.

Funding: Up to ₹30 lakh for 2-3% equity (CCPS), released in tranches through September 2027.

Status: Applications close 31 July 2026. Cohort of 4-5 startups. Program starts September 2026.

Track updates: https://ikpknowledgepark.com/genesis/

MAHA MedTech Mission — ANRF / ICMR / Gates Foundation

India’s largest dedicated medtech funding initiative, explicitly scoped to include AI/ML diagnostic platforms alongside devices and imaging systems.

Supports: Translational development, clinical readiness, commercialization pathways.

Status: First funding round closed. Two more calls expected over the mission’s five-year span.

Track updates: https://anrfonline.in/ANRF/maha_medTech

MEMO-9 JUNE 2026

The CDSCO Submission: What’s Actually Inside

Last month we argued that validation isn’t a final act — it’s something the strongest teams shape from the beginning.

This month we go one layer deeper. Into the submission itself. For all the anxiety around CDSCO certification and licensing, very few have actually looked inside a complete submission and asked the only question that matters:

What is this document really made of?

Not the portal. Not the fees. Not the timelines.

The anatomy and physiology.

Once you see the anatomy, the friction stops being mysterious. It becomes predictable. And predictable problems are solvable problems.

A submission has many parts — far more than most founders expect when they start. But the failures cluster. After enough of these, across devices, IVDs, software and combination products, you start to notice the same handful of places where things quietly come apart.

Founders rarely fail on the science. They fail on the seams. The places where one part of the submission silently contradicts another.

Here’s where the friction tends to live.

Intended Use and Classification

Everything starts here. And almost everything that goes wrong, starts here too.

Your intended use statement is not a marketing line. It is the single sentence that determines your device class, your evidence burden, your labelling claims, and your entire regulatory pathway.

Founders waste months here — not because it’s hard to write, but because they write it once, early, and never reconcile it again.

Then the clinical protocol claims something the intended use didn’t promise. The label implies a use the classification doesn’t cover. The risk file mitigates hazards for a different product entirely.

The document stops agreeing with itself. And that disagreement surfaces long before anyone evaluates your technology.

Risk Management

It is the beginning, middle and end of medtech development, not something to do once the product finishes. If this is not done right, startups pay and often more than money.

The most capable engineering teams underperform because they treat the risk file as a document to produce, rather than a logic that has to thread through everything else.

A risk control that isn’t verified in your testing. A hazard that never appears in your labelling. A residual risk the clinical plan was supposed to address but doesn’t.

Each gap is small. Together they signal a team that built the file to satisfy a checklist, not to understand its own product.

Risk files are read for coherence, not just completeness. That distinction quietly costs founders entire review cycles.

Clinical Protocols

Here the waste is usually strategic, not technical. It’s called protocol design because there is an art to this science. The how, why, who, when and is it ethical/worth it is part of this. It combines math, medicine, philosophy and engineering.

Teams design clinical evidence to prove the device works — when the real task is to prove the specific claim, for the specific intended use, in the specific population the classification demands.

Measure the wrong endpoint and the data is clean but useless. Pick the wrong site or season and recruitment stalls. Generate strong evidence for a claim you never intended to make, and you’ve funded a study that doesn’t move your submission forward.

The protocol has to answer back to the intended use. When it doesn’t, you’ve spent the most expensive part of the journey on the wrong question.

Labelling Compliance

The most underestimated section. And often the last one written, which is precisely the problem.

Labelling is where every earlier decision gets cross-examined. Your claims, your intended use, your risk warnings, your population — all of it has to resolve, consistently, on the label.

Founders treat it as formatting. In practice it’s truth-testing.

An instruction that overstates the claim. A warning that contradicts the risk file. A use case the classification never approved.

The label is where a submission’s internal contradictions tend to surface all at once.

The Query Loop

And then the queries arrive. This is a feedback loop like hunger, hormonal imbalance etc. It’s a good thing to be able to adjust, and not just pass/fail.

It’s tempting to read every round of questions as the process being slow. But the questions themselves are almost always pointing at exactly the seams above — the place where two parts of your own submission disagree.

The teams that move fastest aren’t the ones with no queries. They’re the ones whose submission was internally consistent enough that the queries are narrow, and the answers already exist in the file.

There will always be some queries, so prepare for minimizing them and having the answers. It’s not just having the answers, it is core of communication.

What This Really Is

Step back, and the pattern is clear.

A submission is not a stack of independent sections. It is one argument, repeated across many documents, that has to say the same thing every time.

Intended use, classification, risk, clinical evidence, labelling, responses to queries — they are not separate stories. They are the same claim, viewed from different angles. The submission holds together, or doesn’t, on whether those angles agree.

Founders don’t usually lose time because the work is intellectually hard.

They lose it because no one is checking whether their own document agrees with itself, end to end, before it goes in.

We’ve seen enough of these now to know exactly where the friction lives.

So we started building for it. More on that in the coming months.

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Grants Spotlight

MedTech Mitra — ICMR, CDSCO & NITI Aayog

Not a grant, but one of the most relevant support mechanisms for founders approaching clinical evaluation and regulatory pathways.

Supports: Clinical evaluation guidance, regulatory facilitation, expert mentorship.

Status: Ongoing

Track updates: https://medtechmitra.icmr.org.in/

Not merely a program, MedTech Mitra serves as a comprehensive ecosystem for founders navigating the path from initial concept to commercial deployment. It bridges the gap between technical prototyping and manufacturing readiness by aligning clinical evaluation, regulatory facilitation, and strategic mentorship into a single, cohesive framework for impact. – Dr. Dasmit Singh, Expert- Medtech Mitra.

Biotechnology Ignition Grant (BIG) — BIRAC

India’s flagship early-stage medtech and biotech grant for moving from idea to proof-of-concept.

Supports: Technical feasibility, prototype development, proof-of-concept validation.

Does not cover: Regulatory submissions, clinical trials, or late-stage validation studies.

Funding: Up to ₹50 lakh (non-dilutive)

Status: Next call not yet announced

Track updates: https://birac.nic.in/big.php

MAHA MedTech Mission — ANRF / ICMR / Gates Foundation

India’s largest dedicated medtech funding initiative focused on devices, diagnostics, imaging systems and AI-enabled healthcare technologies.

Supports: Translational development, clinical readiness and commercialization pathways.

Status: Current funding round closed. Future calls expected.

Track updates: https://anrfonline.in/ANRF/maha_medTech

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At Just Yukti, we help you move through India’s complexity with clarity, confidence, and a little strategic yukti.

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MEMO-8 May 2026

Clinical Intelligence Starts at the Beginning, Not the End

One of the stranger things about healthcare is how often validation is treated as a final act.

As if products are first imagined, then engineered, then stabilized — and only after all of that do they enter the clinic to be “validated.”

The language itself creates distance.

Validation becomes a stage.
A regulatory hurdle.
A study to complete.
A document to submit.

But after enough conversations across healthcare systems, product teams, clinicians, regulators and founders, we are beginning to suspect that the strongest medical products are not validated at the end.

They are shaped through validation from the very beginning.

Not in the formal sense.
In the cultural sense.

Recently, we were speaking to Ravi Krishna about his time helping build a low-cost OCT retinal imaging device at Zeiss Asia Pacific. The original mandate sounded deceptively simple: create a more affordable version of an existing high-end product.

But affordability changed the physics of the system itself.

Reducing the quality of the spectrometer created image gaps large enough that the original software architecture stopped functioning reliably. Suddenly, what looked like a straightforward engineering exercise became something much deeper. The team had to rethink the entire pipeline from scratch.

What stayed with us from that conversation was not the technical complexity.

It was the rhythm of how the team kept returning to the clinic.

Again and again.

Not because regulation demanded it.
Not because a clinical study had formally begun.
But because they understood, perhaps instinctively, that clinical quality could not be outsourced to a downstream validation phase later.

The product was being shaped in conversation with clinical reality itself.

The team spent months interacting with ophthalmologists across India and China. They were not simply gathering feature requests. They were trying to understand patterns of trust.

What did doctors notice immediately?
What kinds of inaccuracies became unacceptable?
Where did confidence in the system break down?
Which errors were clinically survivable, and which ones fundamentally altered interpretation?

One detail Ravi mentioned stayed with us.

The team became deeply focused on fovea detection because once the fovea is inaccurately identified, every downstream calculation begins to drift. That insight did not emerge from a regulatory checklist. It emerged from sustained proximity to clinicians and the realities of diagnosis itself.

This distinction feels increasingly important in modern healthcare.

Especially because many founders still approach clinical validation as evidence generation for regulators, rather than as an ongoing conversation between:

• product behavior,
• clinical use,
• patient reality,
• and system trust.

The strongest healthcare teams seem to operate differently.

They do not build products first and validate them later.

They build products while continuously interrogating how clinical evidence is taking shape around the product itself.

And that changes everything.

Because once validation enters early, development stops being purely technical.

Questions become more layered:

• Are we measuring what actually matters clinically?
• Does the workflow survive real environments, or only ideal ones?
• Which endpoint matters most to regulators versus clinicians?
• What level of reproducibility will this category eventually demand?
• Which compromises are operationally acceptable, but clinically dangerous?
• What kind of evidence will this product need five years from now, not just at launch?

At that point, validation is no longer downstream from product development.

It becomes inseparable from it.

This is also where the artificial separation between clinical and regulatory strategy begins to collapse.

Healthcare companies often structure these as independent functions.
Engineering builds.
Clinical validates.
Regulatory documents.

But in reality, all three are orbiting the same central question:

Can this product create reliable clinical outcomes consistently enough to deserve trust?

And trust, unlike compliance, cannot be retrofitted.

Perhaps this is why some smaller teams move faster than much larger organizations despite having fewer resources.

Not because they ignore rigor.
But because their understanding of quality is less procedural and more integrated.

In many large systems, quality slowly becomes abstracted into documentation layers, fragmented ownership and process choreography. The people writing requirements are often distant from the people experiencing the workflow. Product understanding becomes decentralized. Teams optimize for process completion rather than coherence.

But the best healthcare products rarely emerge from procedural completion alone.

They emerge from proximity.

To clinicians.
To patients.
To workflows.
To edge cases.
To uncertainty.
To repeated confrontation with reality.

Ravi described a development culture where engineers interacted directly with clinical environments, where testing rigor was embedded early, and where the product evolved continuously through real-world feedback loops rather than waiting for a final validation event.

What emerged from that process was not simply a compliant product.

It was a clinically literate one.

And perhaps that is the deeper shift healthcare is slowly moving toward.

Validation is no longer just about proving that a product works.

It is increasingly about whether the company itself has learned enough about the clinical world to build responsibly inside it.

Quality, in the end, may be less procedural than cultural.

And culture is shaped long before the first formal validation study begins.

Grants Spotlight

Clinical Validation and Evidence Generation Support Scheme — ICMR MedTech Mitra

This initiative was designed to help startups navigate clinical evaluation, protocol alignment, clinician access and regulatory pathways earlier in the product lifecycle — particularly relevant for devices, diagnostics and AI-assisted platforms entering real-world validation stages.

While not a pure grant program, it significantly lowers one of the biggest barriers early-stage founders face: structured clinical access.

Support includes:

• Clinical mentorship
• Hospital and investigator matchmaking
• Validation pathway guidance
• Regulatory facilitation support

Best suited for:
Startups approaching pilot studies, usability validation, feasibility studies or early clinical deployment.

Track updates:
https://medtechmitra.icmr.org.in/

Biotechnology Ignition Grant (BIG) — BIRAC

Still one of the most important early-stage funding mechanisms for Indian healthcare founders moving from idea to translational proof-of-concept.

While BIG is not designed for large-scale clinical validation studies, it is often where many strong healthcare products begin building their first evidence foundations:

• technical feasibility,
• prototype refinement,
• pilot testing,
• usability validation,
• translational development,
• and early product-risk reduction.

For founders building in devices, diagnostics and digital health, the program is particularly valuable because it allows teams to start engaging with validation thinking before larger institutional or regulatory pressures arrive.

Funding:
Up to ₹50 lakh (non-dilutive)

Next expected call:
Likely July 2026 cycle

Track updates:
https://birac.nic.in/big.php

School of International Biodesign (SiB) — Clinical Need-Finding & Translational Innovation

Formerly known as Stanford-India Biodesign, SiB is one of the most influential translational medtech innovation programs in India. Based at AIIMS and IIT Delhi, the program was originally built in collaboration with Stanford Biodesign and remains deeply grounded in clinical immersion, unmet-need identification and evidence-informed medical product development.

What makes SiB particularly relevant to this month’s memo is its philosophy:
the best healthcare products are not built in isolation from the clinic — they emerge through sustained interaction with clinicians, workflows and patient realities.

Areas of focus include:

• Clinical immersion
• Need-finding
• Workflow observation
• Translational medtech innovation
• Human-centered device development
• Early validation thinking

Best suited for:
Founders, researchers and operators trying to build clinically grounded healthcare products rather than purely technology-led solutions.

Apply / track updates:
School of International Biodesign (SiB) (schoolofbiodesign.in)

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MEMO-7 April 2026

The Hardest Thing to Build

Last month, we spoke about hard tech- interventional, invasive, impactful. The part of healthcare where you’re no longer interpreting the problem- you’re inside it, trying to change the outcome.

What we didn’t get into is what it actually takes to build here. Or how long it takes. Or what gets lost in the waiting.

Because “hard” is often misunderstood. The assumption is that complexity comes from engineering- precision, materials, miniaturisation. But in interventional devices, engineering is often the most solvable part of the problem.

What makes this category difficult is that these products sit at the intersection of clinical behaviour, regulation, manufacturing, capital, hiring, and usability- each operating on its own timeline, with its own incentives. 

None are designed to move together. That misalignment is the real challenge.

Regulation
For newer categories, the regulatory pathway often doesn’t exist. When Saiprasad Poyarekar (Pacify Medical), approached CDSCO with a combinational device, there was no clear framework to classify it. The system didn’t quite know what to do with the product.

So the pathway had to be constructed.

By identifying a comparable USFDA-approved device (Resell), building a substantial equivalence argument, and working with experts who could translate the science into something regulators could process, approval was eventually secured.

This is not unusual. In emerging categories, founders don’t just navigate regulation- they help define it.

Adoption
Approval is not adoption.

Doctors don’t adopt based on regulatory clearance; they adopt based on evidence they trust. And that evidence is slow to generate.

For Pacify Medical, the turning point came through an emergency use case in Nepal. The resulting clinical outcomes became the first credible proof point. Back in India, adoption began cautiously, starting with donor wound sites, on the basis of the Nepal deployment and advice of a Canadian physician, before progressing to burn wounds.

The pattern is consistent: approval earns you the right to generate evidence. Evidence earns you the right to be used. And use earns you the right to be believed.

Which is why the early advantage in this category doesn’t come from being first to build. It comes from being first to be believed.

Manufacturing
The challenge is not just capability, but consistency at a level where variance is unacceptable. Many teams compensate by building hybrid models-  combining local manufacturing with global design or expertise to achieve the required precision.

The advantage here is not speed.

It is control.

Capital
Capital does not move at the same pace as the product.

Interventional devices require long development cycles- often 10 to 15 years- with capital needed across clinical validation, regulatory milestones, and manufacturing scale-up. But venture capital in India is not structured for that timeline.

Funds operate on shorter cycles, with defined return horizons. Which means capital is available- but not always patient.

This creates a mismatch.

Startups are forced to stitch together funding across grants, early investors, and strategic partners- raising not just for growth, but to survive each phase of validation.

The constraint is not just access to capital.

It is continuity.

Hiring
The kind of talent this category depends on tends to sit inside incumbents like Johnson & Johnson, Stryker, Medtronic, or within large institutions, not startups.

So, teams aren’t built the usual way.
Expertise is accessed- through consultants, part-time specialists, and institutional collaborations- while building a younger core team that can execute without fully owning the system.

Which means the company that is built here is not just a product company, it is a coordination layer for expertise you cannot fully own.

Usability
A device that works is not enough. It has to fit into how medicine is actually practiced.

Because in practice, better results don’t automatically win. What wins is what fits into the existing clinical workflow.

Usability, in this category, is not a finishing layer. It is the difference between a product that is approved and a product that is used.

Time
None of this happens sequentially.

Clinical validation, regulatory progress, product development, and funding all move in parallel. If one slows down, everything slows down.

This expands timelines and capital requirements in ways most early-stage plans underestimate.

The few companies that have scaled reflect what this requires. Meril Life Sciences, now present in over 150 countries, took nearly two decades and over $500 million in sustained investment across clinical trials, regulatory approvals, and manufacturing scale to reach global markets.

Before that, institutions like SCTIMST built foundational innovations through publicly funded research. The TTK Chitra heart valve- developed over years of clinical and engineering collaboration- has seen over 100,000 implants, and remains one of the most affordable mechanical valves globally. 

But they operated with timelines and mandates that private startups cannot replicate.

What This Really Is
This is not just a product challenge.

It is a coordination problem across systems that do not naturally align.

And that changes how you build.

You stop optimising for speed.
You start optimising for sequence.

You stop asking, “How fast can we build this?”
And start asking, “What needs to align for this to work?”

Very few teams are set up to think this way.

We’ve started to map what it would take.

Grants Spotlight

Biotechnology Ignition Grant (BIG) — BIRAC (Government of India)
One of the most relevant early-stage grants for medtech founders building from idea to proof-of-concept. Supports validation of technical feasibility, early prototyping, and initial clinical thinking — before institutional capital typically comes in.
The last cycle closed in March, but given its predictable cadence, this is one to actively prepare for.

• Funding: Up to ₹50 lakh (non-dilutive)
• Next expected call: July 2026
• Apply / track updates: https://birac.nic.in/big.php

BIRAC Open Call (Rolling Proposals)
For teams that are slightly further along — with defined problem statements, early data, or institutional partnerships. Unlike structured cycles, this allows submission within a broader window, making it one of the few currently actionable opportunities. Particularly useful for translational work that doesn’t neatly fit into fixed grant timelines.

• Funding: Varies by scheme (can extend into multi-crore support)
• Deadline: 30 June 2026
• Apply: https://birac.nic.in/cfp_view.php?id=114&scheme_type=46

MAHA MedTech Mission — ANRF / ICMR / Gates Foundation (Government of India) The most significant MedTech-specific grant program currently active. Focused exclusively on medical devices and IVDs — imaging, robotics, AI/ML diagnostic platforms, minimally invasive tech, implants. Specifically designed to reduce import dependence with a target of 3-5x cost reduction. Excludes therapeutics and vaccines. The first call (Oct-Nov 2025) has closed, but the Mission expects to make two more funding calls over its five-year span, giving applicants multiple opportunities to apply. ANRF

• Funding: ₹5–25 crore per project, with exceptional cases eligible for up to ₹50 crore. Funding is milestone-linked across 2-5 years. Funds for Companies
• Eligibility: DPIIT-registered startups, MSMEs, academic institutions, hospitals — TRL 3 or above required
• Next expected call: 2026 (second of three planned calls)
• Apply / track updates: https://anrfonline.in/ANRF/maha_medTech

IHFC–India Accelerator MedTech Impact Call 2026 — IIT Delhi / India Accelerator
A high-impact funding and incubation initiative by the I-Hub Foundation for Cobotics (IHFC) at IIT Delhi in collaboration with India Accelerator, targeting startups with an MVP, validated prototype, or early market traction (TRL 4+). Startup Grants India Not a pure grant — structured as co-investment.

• Funding: Co-investment opportunity of up to ₹5 crore per startup, along with incubation, mentorship, and investor access Startup Grants India
• Eligibility: India-registered, TRL 4+, at least two full-time founders
• Status: Currently open (as of early April 2026)
• Apply / track updates: https://ihub-data.iitd.ac.in

MEMO-6 March 2026

The Other Side of the Diagnosis

We just spent three months studying how India diagnoses disease. Now we’re exploring how India treats it.

The good news: there’s a lot of room. The better news: someone has to build it.

Our latest report- IVD’s Inflection Point– started with a simple provocation: India isn’t short on diagnostic tests. It’s short on diagnostic value. The real opportunity isn’t cheaper tests, it’s “more biology per rupee”- earlier signals, richer clinical insight, decisions that actually change outcomes. Our favourite insight from the report was:
Rs 2 lakh per patient per year for Dialysis
Rs. 400 per patient for early detection

But the technology itself is anything but modest. A new generation of diagnostics is reshaping what’s even possible. Point-of-care chip systems that compress an entire laboratory onto a device small enough to sit at a clinic in rural Maharashtra. Multi-omics platforms that don’t just answer “positive or negative” but characterise disease risk, progression, and response with a precision that would have seemed excessive five years ago.
AI-augmented tools that extend specialist expertise into settings that have never had a specialist.
Three distinct categories, each attacking a different constraint- infrastructure, signal depth, workforce- all converging on the same idea: more biology per rupee.

What struck us most wasn’t the ambition. It was seeing it already happening. The founders we spoke to- building credible, scalable hardware IVD platforms, already with connectivity and AIMl algorithms in mind. They are developing AI-enabled multi-molecule biopsy tests for reliable point of care oncology screening. This is not building for India’s needs alone. They are building world-class products. With the right funding, the right ecosystem support, and the right regulatory runway, these companies have a genuine shot at reshaping how diagnostics work- not just here, but globally.

India, it turns out, is not just a large market. It is a forcing function for innovation. Building for a population this large, this diverse, this cost-sensitive, and this underserved produces solutions that are inherently more robust, more scalable, and more transferable than anything designed in a well-resourced system with nowhere to push back.

Build in India, for the world. That’s where this is going. Innovate in India and this does not mean we only sell in India or develop in an Indian silo.

So we started thinking about the other end of the care continuum.

Because a diagnosis is only the beginning of a story. At some point, someone has to actually fix the problem. That’s where the hard-tech comes in- interventional, invasive, impactful. Deals with the hard (difficult, constrained) problems. Has hard solutions (tangible but often complex). Needs cold hard cash (lots of funding) along with people not afraid of the long hard road (grit and resilience). These are devices that go into the body to fix, supplement, replace and heal the body. Implants, catheters, surgical robotics. The category where engineering meets harsh biology and neither gets to compromise because of the stakes.

India has the clinicians. It has the engineers. It has patients– more of them, with more conditions, than almost anywhere else- who would benefit from both better diagnostics and better interventions. Interventions can demonstrate immediate impact and don’t require the “sell” of prevention. While prevention may be better than the cure, people still resonate with a literal pain point eliminated. 

What it’s still assembling is the ecosystem that connects these pieces: the clinical networks, the precision manufacturing, the patient capital, the regulatory clarity and expertise. The only way to really lower our import dependencies is to intervene at the interventional level.

The IVD founders are already proving it can be done. The interventional space is asking the same question, one beat behind.

Which makes this, depending on how you look at it, either a very hard problem or a very interesting moment.

Grants Spotlight

MAHA MedTech Mission — Government of India
A landmark ₹750 crore, 5-year initiative by ANRF in collaboration with ICMR and the Gates Foundation, backing indigenous development of medical devices and IVDs — including robotics, minimally invasive technologies, implants, and AI/ML platforms. The first funding round has closed, but two more calls are expected over the mission’s lifetime. If you haven’t registered on the ANRF portal yet, now is the time to get familiar with the process.
Funding per project: ₹5 crore – ₹50 crore (milestone-linked, no equity sharing required) Watch: anrfonline.in

Indo-Swiss Joint Research Programme (ISJRP) 2026 — ICMR, DBT & SNSF
Open call for collaborative research projects between Indian and Swiss institutions under a One Health framework — human, animal, and environmental health intersections. Relevant for founders with academic or research institution partners looking to build international credibility and bilateral R&D relationships.
Funding: Up to ₹2.5 crore (Indian side) for up to 4 years
Application deadline: May 5, 2026
Apply via: snf.ch

About the newsletter

India’s market rewards those who can navigate, not just innovate. Regulations and red tape aren’t going away — but with the right guidance, they can become your competitive edge.

At Just Yukti, we help you move through India’s complexity with clarity, confidence, and a little strategic yukti.

Subscribe to explore how we turn India’s challenges into opportunities for growth.

MEMO-5 February 2026

The importance of a well-defined problem statement in healthtech

During the course of our work at Just Yukti, we meet all kinds of entrepreneurs. First-timers, serial entrepreneurs on their 5th startup and everyone in the middle. And we have realized one thing: Success often starts with a well-defined problem statement.

Many people think a problem statement is decorative – something to fill in slide 2 of the pitch deck to show investors that it is a billion dollar market and they need to give you money. But a well-defined statement is so much more than that.

Let us take a fictional startup RapiDx. They are developing IVDs for sepsis.

Their first version sounded familiar: “Sepsis affects 9 million people annually in India. To tackle this problem, we’ve built a high-sensitivity molecular test for early sepsis detection.” Technically correct. Seems to signal a large problem. But it is still very fuzzy and superficial – why is sensitivity important? Why is early detection important?

After spending time in ICUs, hospital labs, and antibiotic stewardship committees, the problem statement sharpened: “In hospitals, blood culture results take 48–72 hours leading to clinicians prescribing medication for sepsis without reliable pathogen data in the first critical 6 hours. This leads to antibiotic overuse, subsequent resistance and higher costs. We have developed a high-sensitivity molecular test that gives clinicians actionable pathogen ID within just 15 minutes”

See the difference?

That specificity is powerful. It signals subject-matter depth without trying too hard. It tells the listener that this is a team who feels the problem, who can communicate the pain to the customer. Investors don’t need to be intensivists to recognize that this team understands workflow timing, lab bottlenecks, and stewardship pressures..

It also forces multidisciplinary alignment. Engineers stop obsessing only over analytical sensitivity and start focusing on turnaround time and integration with lab workflows. Clinical advisors clarify where the test actually fits in decision-making. Commercial teams understand who feels the pain most – ICU heads, infection control committees, hospital administrators.

In regulated environments, this clarity matters even more. The problem statement helps define intended use early. Is RapidDx a rule-in diagnostic? An adjunct to blood culture? A triage tool to guide early antibiotic decisions? That distinction shapes the regulatory pathway, risk classification, and the clinical validation plan – right from the get-go.

It even sharpens clinical validation. Instead of hand-wavy claims about “better outcomes,” (or worse, measuring the wrong outcome entirely), RapidDx can measure what actually matters: time-to-targeted therapy, reduction in broad-spectrum antibiotic days, ICU length of stay.

Startups don’t need bigger visions. They need sharper questions. A strong problem statement is often the first real proof that a team understands the system it’s trying to change.

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Union Budget 2026 – and what it means for medtech startups.

February means Union Budget time in India. And this year is a continuation of the theme of previous years, along with quiet additions: scale infrastructure, deepen reimbursement, localize manufacturing, and strengthen research. For health and medtech founders, this is a system-building budget.

Here’s our take on key highlights from the Budget

Health Spending Sustains Above ₹1.1 Lakh Crore

Public health allocation remains above ₹1 lakh crore, with continued capex under PM-ABHIM (₹64,000+ crore outlay). Critical care blocks, district labs, and surveillance systems continue expanding.Diagnostics, imaging, AI-triage, and hospital IT now plug into more predictable procurement cycles.

PM-JAY as a Demand Engine

With ~55 crore beneficiaries and annual claims exceeding ₹80,000 crore, Ayushman Bharat PM-JAY is now a reimbursement backbone. If your solution aligns with a package code, you’re tied to a government payment rail, not just hospital budgets.

Digital Health Is Infrastructure

With 50+ crore health accounts created under ABDM, interoperability is no longer optional. API-ready, ABDM-compliant solutions will move faster in both public and private ecosystems. Many state governments already mandate ABDM-compliance as a pre-requisite for tenders – it’s only a matter of time before the others catch up as well.

Manufacturing Momentum

The ₹3,400 crore PLI scheme and the National Medical Devices Policy 2023 aim to reduce 70–80% import dependence in high-end devices and IVDs. Domestic manufacturing economics are improving  – especially for export-oriented startups.

Clinical Trials Expansion

This was the most interesting addition – a proposed network of 1,000+ accredited clinical trial sites strengthens India’s research backbone. For founders, this means faster validation, broader recruitment pools, and stronger global credibility for Indian data.

Capital & Tax Support

• ₹10,000 crore Fund of Funds (SIDBI)
• Expanded Credit Guarantee Scheme for Startups
• Section 80-IAC tax exemption continuity
• Angel tax relief for DPIIT-recognized startups

The Big Picture: As with previous years, the takeaway remains the same. Manufacture locally. Integrate digitally. Align with reimbursement. Generate clinical evidence. Healthcare founders who think in systems will be best positioned to scale.

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Grants Spotlight

MIT Solve Future Health Challenge: Building Anticipatory Health Systems through Population Sensing

Global open innovation call (worldwide) to develop sensing-enabled technologies that help health systems predict and prevent disease, shifting from reactive to anticipatory care.

Application deadline: February 23 2026.

Prize: USD 200,000 grand prize + two USD 50,000 runner-up prizes (plus honourable mentions & visibility/mentorship).

https://solve.mit.edu/challenges/future-health-challenge

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About the newsletter

India’s market rewards those who can navigate, not just innovate. Regulations and red tape aren’t going away — but with the right guidance, they can become your competitive edge.

At Just Yukti, we help you move through India’s complexity with clarity, confidence, and a little strategic yukti.

MEMO-4 January 2026

Big Numbers, Bigger Questions: Inside India’s Digital Health Push

India has done something pretty rare in digital health: it’s actually built the plumbing.

With the Ayushman Bharat Digital Mission (ABDM), the country has put in place digital health IDs, registries, consent frameworks, and interoperability standards at a scale most health systems only talk about. That part deserves real credit.

But once the infrastructure is live, the harder questions begin. Questions that we felt needed answers to STAT, so our healthcare system can leapfrog beyond challenges. 

So we did a thing this past December. 

We looked at the hard data, crunched the numbers and came out with our very first whitepaper. This report looks at ABDM at this exact moment – when the excitement of building is giving way to the realities of use. We asked a simple question: now that the system exists, what has actually changed at the grassroots level? And used three very different lenses to answer the question: a policy and comparative benchmarking lens, an economic lens and a sentiment lens. 

What we found
Well, in a nutshell – we found that some things are working well while others are still catching up.

ABDM’s federated design is a real strength. Instead of one central system, it allows states, hospitals, startups, and payers to build their own solutions on shared rules. That flexibility makes sense for India’s diversity – and it has enabled ecosystem participation.

But federation also brings trade-offs. When everyone can build, ownership of outcomes becomes fuzzy. Adoption depends heavily on local incentives. And today we see that success is often measured by activity – IDs created, systems connected – rather than by lived experience for patients and clinicians.

Another familiar pattern shows up: technology is moving faster than behaviour. The digital rails are mostly in place, but workflows, payments, and habits take longer to change. Globally, digital health only scales when incentives follow – and ABDM is no exception. (In some positive related news though, it seems some states are taking the challenge seriously. UP recently reported sharply improved Ayushman Bharat claim settlements, cutting pendency from over 10 lakh to ~3 lakh and ensuring payments within 30 days. Link)

Trust is the other thread running through the report. India’s privacy and consent direction is strong, but as adoption grows, cybersecurity readiness and operational resilience will matter just as much as policy intent.

The big takeaway: ABDM has built the foundation. The next phase is about alignment – governance, incentives, trust, and outcomes. 

We didn’t want to leave it there though – we brought in our Just Yukti touch and came up with six actionable points that we felt would really make ABDM a global case study for leapfrogging – just like UPI.

Do read the full whitepaper here: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=5988514 or on our website https://justyukti.com/articles/. Feel free to drop us a line with your thoughts – we are always interested in hearing from you!

MEMO-3 December 2025

The Holiday Reset: Just Yukti’s PILOT Framework for Healthtech Founders

If you are a healthtech founder, you don’t need us to tell you that your journey is hard. Clinical risk, regulatory fog, slow adoption, long sales cycles- these are problems that you probably already have nightmares about.

You may, however, like us to tell you that we’re seeing very encouraging patterns. India’s startup ecosystem is now making massive strides in making things easier for healthtech founders.

State – global partnerships, stronger incubators, and Big Tech infrastructure investments are reducing friction at exactly the stages where startups usually stall. Add to that recent government moves – ABDM maturity, expanded sandbox pathways, continued Startup India tax incentives, and clearer medtech/regulatory playbooks – and the terrain is less hostile than it was even a year ago.

We also see a not so positive pattern – founders don’t know how to capitalize on these initiatives. Yet.

So in this month’s newsletter, we outline how healthtech founders can operate in PILOT mode – and make the path to scale even smoother.

The PILOT Framework

P – Policy leverage: ABDM, health data standards, and regulatory sandboxes aren’t paperwork that you hold your nose and fill – they’re shortcuts to credibility if used correctly.

Maps your products to ABDM building blocks early (Health IDs, consent artefacts) and use regulatory sandbox to pilot updated clinical workflows without full-scale approvals.

Initiate a pre-submission classification discussion to confirm and document the pathway (class, evidence needs, timelines) before writing a single line of clinical claims.

Use Startup India recognition to get benefits such as discounts on patent filing, tax breaks and access to certain government funding.

List products on GeM to access faster procurement pathways with state health departments.

I – Institutions: Technology business incubators, IIT and IISc ecosystems, hospital systems like MUHS, JIPMER and AIIMS are not just co-working spaces and sounding boards. They’re your clinical proof engine.

Partner with a medical college–linked TBI to validate clinical need, review clinical workflows and run observational studies.

Use faculty physicians as co-authors on validation reports. Bonus: having physicians as PIs unlocks grant funding from institutions like AIIMS which may be inaccessible otherwise to the average startup.

L – Large platforms: Cloud, AI, and infra partnerships aren’t “later-stage” problems. They’re how you design for scale and compliance from Day 1

Google Cloud, AWS, Azure – they are already built for hyperscale (secure data storage, AI tooling). Maximize the utilization from day 1.

All these platforms provide startup credits. Use them to simulate scale and stress-test data pipelines.

Design architecture assuming future hospital IT integration – with all of its idiosyncrasies and security standards.

O – Outcomes: not MoUs Use partnerships to run pilots, generate relevant evidence, and unlock adoption – not logo slides.

Have clear pilot metrics: are you reducing readmission, saving clinical time, catching disease earlier, or a mixture of some or all?

Defined timelines and success thresholds with hospital partners make more sense than a PR blitz announcing a vague partnership.

Wherever possible, get written commitment to convert pilots into paid deployments.

Use hospital startup accelerators strategically to get a jumpstart into their procurement process.

T – Trusted: SMEs Clinicians, regulatory experts, hospital ops leaders. Don’t “consult” them – embed them. This is where most founders under-invest and over-pay later. Whether a physician, a regulatory consultant or a clinical expert, use them from day 1.

Funding helps you start. Ecosystems help you survive, validate, and scale. Smart founders leverage the ecosystem to the max, in order to get ahead.

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Around the internet – Long Read

Bootstrapping isn’t normally something associated with startups in sectors with slow market cycles like healthtech. However, it’s a rewarding road, especially for founders who value independence and know how to leverage ecosystems. Which is why we loved

Qubit Capital
‘s guide on bootstrapping for healthtech founders. Read it here in its entirety

https://qubit.capital/blog/bootstrapping-healthtech-venture

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Grants spotlight

Future of Health Grant (Jan 31st deadline)
: Link to apply

The Future of Health Grant for digital health startups promises CHF 10000 – 50000 in non-dilutive funding for healthtech startups that are considering Switzerland as a potential market for their solutions. There is no barrier to domicile of the startup, with the only requirement being a concrete plan for the Swiss healthcare system, such a pilot project or a market entry partner.

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About the newsletter

India’s market rewards those who can navigate, not just innovate. Regulations and red tape aren’t going away — but with the right guidance, they can become your competitive edge.

At Just Yukti, we help you move through India’s complexity with clarity, confidence, and a little strategic yukti.

Subscribe to explore how we turn India’s challenges into opportunities for growth.

MEMO-2 November 2025

Navigating India’s HealthTech Clinical and Regulatory Maze : An IMPACT Guide for Startups

Building a medical device or digital health solution in India can be fun – but navigating approvals, trials, and compliance can feel like driving through unfamiliar territory. With CDSCO, MDR 2017, ICMR, and data laws all in play, it’s easy for your car to grind to a halt. In this second edition of the Yukti Memo, we talk about how the IMPACT framework is a simple way for startups to move forward with clarity and confidence.

🧠 I – Identify the Real Problem

Pre-regulatory/ pre-clinical work is important – and often overlooked. Validate your product/solution through intensive needs validation and immersion. Shadow clinicians, talk to patients, observe workflows – is the problem real, urgent, and unmet? Getting this wrong will be like picking a two door coupe to go off-roading in the Western Ghats – you may eventually complete the journey but you would have probably done it more comfortably with fewer breakdowns in a Jeep with all-wheel drive.

🗺️ M – Map the Intended Use and the Regulatory Landscape

Your intended use defines everything. What does your product do, who is it for, and how is it used? That single sentence determines whether your solution qualifies as a medical device, what class it falls under (A–D per MDR 2017), and whether CDSCO or ICMR oversight applies. Nail your intended use early to avoid surprises down the line – it’s your startup’s compliance GPS.

🔬 P – Plan Clinical Validation

Like test-driving your car, you need to prove your solution works. CDSCO requires clinical trials for higher-risk devices, while digital tools might need usability studies or structured feedback. You also need to be strategic about your site and timeframe – for e.g. if you are building a malaria diagnostic, you will be able to get the bulk of your studies done only in the monsoon when malaria peaks. You may also see a faster outcome in a public hospital in Maharashtra than at AIIMS Rishikesh.

🧪 A – Apply Real-World Evidence (RWE)

Lab tests are one thing – real traffic is another. RWE shows how your product performs in everyday healthcare settings, with actual patients and clinicians. Pilot deployments and observational studies can help build trust, validate claims, and support regulatory submissions. And bonus – you will have a compelling narrative for your sales pitch!

💡 C – Connect with Value via HTA

Getting approved is great; getting adopted is better. Health Technology Assessment (HTA) evaluates whether your product improves outcomes and saves costs – key for government programs or hospital buyers. If your app reduces clinician time or your device lowers complications, capture that data early.

🤝 T – Tap into Guidance & Support

You don’t have to go it alone. Programs like ICMR’s MedTech Mitra (and the team at JustYukti – shameless plug!) offer mentorship and help with clinical and regulatory navigation. Talk to peers, consult experts, and engage with regulators early – they will help you navigate common roadblocks and avoid expensive mistakes that will need time-consuming course corrections later.

With IMPACT as your compass, you can build smarter, navigate faster, and bring innovations to market that truly improve care. And most importantly, you will avoid setbacks that bring you back to square one!

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Grants spotlight

Hello Tomorrow (Nov 30 deadline):

Link to apply

The Hello Tomorrow Global Challenge is a global competition that awards €100,000 as a grand prize, plus two additional equity-free prizes of €25,000 for second place and a pre-VC stage category. It is targeted at early-stage deep tech startups or projects worldwide (pre-seed through Series A, with prototype or proof of concept) working on science-driven innovations across sectors.

Biotechnology Industry Research Assistance Council (BIRAC) BIG (Nov 30 deadline):

Link to apply

With up to ₹50 lakh in non-dilutive funding, the 25th call of the BIRAC BIG grant gives early-stage entrepreneurs the freedom to validate risky concepts, build prototypes, and generate the data needed for serious commercial traction. If you’re a scientist-founder or a deep-tech dreamer looking to bridge the gap between lab and market, BIG is designed to be that catalytic first cheque that helps you move fast, experiment confidently, and stand out in India’s growing biotech ecosystem.

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About the newsletter

India’s market rewards those who can navigate, not just innovate. Regulations and red tape aren’t going away — but with the right guidance, they can become your competitive edge.

At Just Yukti, we help you move through India’s complexity with clarity, confidence, and a little strategic yukti.

Subscribe to explore how we turn India’s challenges into opportunities for growth.

MEMO-1 October 2025

When Good Ideas Meet India’s Red Tape

AarogyaLink- a promising healthtech startup- set out to make chronic care management affordable and accessible across India. Backed by investors and powered by strong tech, they were ready to scale to five states within a year.

Then came reality.

Roadblock 1- licensing. Each state has a different version of the Clinical Establishments Act: with unique forms, fees, and approval timelines. What worked in Maharashtra failed in Karnataka.

Roadblock 2- data compliance confusion. New state-level rules clashed with central telehealth guidelines.

Roadblock 3- each provider insisted on a pilot, having slightly different clinical protocols and needing separate IRB approvals.

Roadblock x, y and z- tax registrations, labor compliance, unpredictable audits, and so on..

The founders were soon spending more time navigating portals than serving patients.

This is the hidden complexity of doing business in India- the federated governance structure, where both central and state authorities play vital roles in regulation and oversight. While this system ensures that local priorities are respected and consumer protection remains strong, it also means that businesses must adapt to varied processes and evolving guidelines across regions. Many startups discover that local nuances and policy ambiguity can slow innovation more than competition does.

AarogyaLink might be fictional – but their story is all too real. At Just Yukti, we help startups navigate exactly this complexity. We turn market uncertainties into actionable clarity- powered by deep functional expertise and born out of the blood, sweat and tears of having done it all before.

We are your experts available on a tap, your fractional CXOs. But most importantly, we are your partners in the trenches, with our sleeves rolled up.

This newsletter is a record of our learnings, a GPS for founders. Here, we’ll unpack key policy developments, share insights from the field, and offer candid (sometimes counter-intuitive) pointers on what really works- and what doesn’t – in the Indian market.

We’ll also keep you updated on funding opportunities for startups and MSMEs.

Stay tuned – clarity is coming.

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India’s Tax System Just Got an Upgrade

A simplified GST structure- and what you need to do to ensure compliance.

Think of GST 2.0 as the long-overdue software update India’s tax system desperately needed- fewer bugs, faster performance, and a much cleaner interface. Launched on September 22, 2025, this reform trims the old four-slab maze into just two main rates- 5% and 18% (plus 40% for luxury and sin goods).

For startups, it’s a serious upgrade, dramatically cutting compliance burdens that previously consumed valuable startup resources. With essentials like office equipment, healthcare, and business services moving into lower tax brackets, pricing structures are simpler, cash flow gets smoother, and founders can focus on building instead of endlessly reconciling invoices.

What can you do with this information?

Update Systems Immediately (Deadline October 31, 2025): Reconfigure billing software, ERP systems, and invoice templates for the new 5%/18% structure. Update e-commerce platforms and POS systems to prevent compliance penalties.

Verify HSN Codes & Pricing: Review every product/service – many products and services have changed categories e.g. essentials moved to 5%, most items standardized at 18%. Update MRP labels by December 31st and renegotiate supplier contracts to reflect new rates.

Fast-Track Registration Benefits: New startups get 3-day GST registration (vs. previous 30 days). Voluntary registration under ₹40L turnover unlocks input credits and B2B credibility.

Optimize Cash Flow: Leverage 90% faster refunds – set up automated reconciliation for sub-30 day refund cycles. Businesses under ₹2 crore skip annual return filing starting FY 2024-25.

Automate Compliance: Implement e-invoicing for threshold businesses and complete Aadhaar authentication for refund eligibility (if you haven’t already). Set automated reminders: GSTR-1 by 11th, GSTR-3B by 20th monthly.

GST and taxation might seem incredibly boring compared to building, but they are some of the most common red-flags seen during investor diligence. We think it is better to deal with a little boredom now rather than scrambling a night before a VC pitch or- worse- when you receive a notice from the IT department!

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Grant Spotlight

PRIP Scheme (Nov 3 deadline)
– Link to apply

The PRIP (Promotion of Research & Innovation in Pharma-MedTech) scheme offers a ₹5,000 crore total outlay. It supports industry-academia collaborations, pharma/MedTech firms, MSMEs and startups through grants (up to ₹100 crore in late-stage projects, up to ₹5 crore in early stage) across a six priority area portfolio.

The PRIP (Promotion of Research & Innovation in Pharma-MedTech) scheme offers a ₹5,000 crore total outlay. It supports industry-academia collaborations, pharma/MedTech firms, MSMEs and startups through grants (up to ₹100 crore in late-stage projects, up to ₹5 crore in early stage) across a six priority area portfolio.

Indian Council of Medical Research (ICMR)
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Department of Pharmaceuticals

Hello Tomorrow Global Challenge (Nov 30 deadline)

The Hello Tomorrow Global Challenge is a global competition that awards €100,000 as a grand prize, plus two additional equity-free prizes of €25,000 for second place and a pre-VC stage category. It is targeted at early-stage deep tech startups or projects worldwide (pre-seed through Series A, with prototype or proof of concept) working on science-driven innovations across sectors.

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About the newsletter

India’s market rewards those who can navigate, not just innovate. Regulations and red tape aren’t going away — but with the right guidance, they can become your competitive edge.

At Just Yukti, we help you move through India’s complexity with clarity, confidence, and a little strategic yukti.

Subscribe to explore how we turn India’s challenges into opportunities for growth.