Connect with us

News

FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder

info

Published

on

Bms2e11 featured.png

Founders building in the healthcare space can’t just build fast and break things. Timelines stretch longer, stakes are higher, and success depends on navigating systems that reward rigor over speed. 

That’s exactly the reality Robhy Bustami, co-founder and CEO of BioticsAI, has been building in. His company is developing an AI copilot for ultrasound that helps detect fetal abnormalities, an area where misdiagnosis rates remain surprisingly high. Bustami joined Isabelle Johannessen on Build Mode to discuss how the company has navigated a highly regulated space and kept the team motivated while cutting through all the red tape.

BioticsAI started scrappy. The team built an early, functioning version of the product for under $100,000, an almost unheard-of milestone in the medical device world. That prototype helped them win TechCrunch Startup Battlefield in 2023, bringing early visibility and credibility. In January, they gained FDA approval, which means they can begin launching in hospitals and growing the business at a new rate. 

From day one, the team approached product development with FDA approval in mind. Instead of building first and figuring out regulation later, they integrated clinical validation, regulatory strategy, and product development into a single process. That meant working closely with clinicians, collecting large-scale datasets, and running structured clinical studies before ever reaching the submission stage.

The FDA process itself is often viewed as a black box, but Bustami emphasizes that founders don’t have to navigate it blindly. Early engagement with regulators, through pre-submission meetings, helped the team align on study design and expectations. Still, risk never fully disappears. For many investors, the biggest question is simple: What if the FDA says no?

Internally, those long timelines create a different kind of challenge: keeping a team motivated when the biggest milestone is years away. At BioticsAI, that meant building a culture of alignment across engineers, clinicians, and researchers, ensuring everyone got to see the wins that were happening.

 “Making sure everyone is completely aligned, even if it’s outside of their technical scope,” Bustami said, “constantly seeing wins on the R&D side,” from clinical studies to new healthcare partnerships.

Techcrunch event

San Francisco, CA
|
October 13-15, 2026

Now, with FDA clearance secured, BioticsAI is entering a new phase: deployment. The company is beginning to roll out its technology in hospitals, with plans to expand beyond obstetrics into broader areas of reproductive health.

Building in healthcare is a long game. It requires patience, discipline, and a willingness to operate in uncertainty. For founders willing to take that path, the reward isn’t just a successful company — it’s the chance to build something that genuinely changes how care is delivered.


Subscribe to Build Mode on Apple Podcasts, Spotify, or wherever you like to listen. Watch the full videos on YouTube. Isabelle Johannessen is our host. Build Mode is produced and edited by Maggie Nye. Audience Development is led by Morgan Little. And a special thanks to the Foundry and Cheddar video teams. 


Apply to Startup Battlefield: We are looking for early-stage companies that have an MVP. So nominate a founder (or yourself). Be sure to say you heard about Startup Battlefield from the Build Mode podcast. Apply here.

TechCrunch Disrupt 2026: We’re back for TechCrunch Disrupt on October 13 to 15 in San Francisco, where the Startup Battlefield 200 takes the stage. So if you want to cheer them on, or just network with thousands of founders, VCs, and tech enthusiasts, then grab your tickets.

Use code buildmode15 for 15% off any ticket type. 

When you purchase through links in our articles, we may earn a small commission. This doesn’t affect our editorial independence.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

News

NPFL: Plateau United vs Kano Pillars to play behind closed doors 

info

Published

on

By

20221102 181736.jpg

Plateau United has announced that their Nigeria Premier Football League (NPFL) Matchday 38 fixture against Kano Pillars will be played behind closed doors.

The Peace Boys made the announcement in a statement on Friday.

Plateau United stated that the decision was reached due to security reasons.

Gbenga Ogunbote’s side will lock horns with Kano Pillars at the New Jos Stadium on Sunday.

Plateau United need a win in the game to secure their top-flight status, while Kano Pillars must avoid defeat to escape relegation.

Kano Pillars sit in 10th position on the NPFL table with 48 points, while Plateau United are 12th with 47 points.

Bayelsa United and Wikki Tourists have already been relegated to the second tier, with two more teams set to join them.

Continue Reading

Business

NNPC accuses Dangote refinery of seeking fuel monopoly in court filing

info

Published

on

By

WhatsApp Image 2023 11 14 at 7.08.40 AM e1761856902627.jpeg

The Nigerian National Petroleum Company Limited (NNPC Ltd) has accused Dangote Petroleum Refinery of attempting to monopolise Nigeria’s fuel market through a lawsuit challenging import licences granted to rival marketers.

In court documents, the state oil company argued that granting Dangote’s request to void or restrict fuel import permits would undermine competition and expose Nigeria to supply disruptions, price instability and threats to national energy security.

The position was contained in a proposed defence filed before the Federal High Court in Lagos in response to a suit instituted by Dangote Petroleum Refinery against the Attorney-General of the Federation.

Reuters reported that the legal dispute has resulted in the Nigerian Midstream and Downstream Petroleum Regulatory Authority (NMDPRA) applying to join the case.

The move comes less than a month after Dangote Petroleum Refinery filed a fresh lawsuit against Nigeria’s Attorney-General, seeking to overturn fuel import licences granted to oil marketers and the NNPC.

PT WHATSAPP CHANNEL

The lawsuit exchange has also broadened the battle over Nigeria’s fuel import policy and the market influence of Dangote’s 650,000 barrels-per-day refinery.

The dispute comes ahead of Dangote Refinery’s planned initial public offering (IPO) in September, raising fresh concerns over market regulation, competition, and the refinery’s future revenue outlook.

In its lawsuit against the government, the refinery argued that licences issued to rival marketers undermine local refining efforts and violate provisions of the Petroleum Industry Act (PIA), which it said was designed to encourage domestic refining capacity.

However, NNPC has rejected the claim, arguing that the law permits the issuance of import licences to companies with local refining licences or established records in international crude oil and petroleum products trading.

The state oil company further argued that regulators retain the discretion to manage fuel imports under Nigeria’s backward integration policy and that there is no outright ban on fuel imports except where local production sufficiently meets domestic demand.

According to the court documents, NNPC also contended that Dangote refinery had failed to provide “credible, independent or verifiable evidence” that it could consistently meet Nigeria’s total fuel demand and guarantee uninterrupted nationwide supply.

Dangote refinery declined to comment on the matter, citing the ongoing court proceedings.

NNPC also denied allegations that it deliberately frustrated Dangote refinery’s operations or withheld crude oil supplies from the facility.

The company said crude oil allocations were determined by operational, commercial, security and logistical considerations.

Fuel marketers have equally opposed Dangote’s suit, warning that restricting import licences could weaken market competition and threaten fuel supply stability across the country.

The court is expected to hear the matter in the coming weeks.

Background

Since commencing operations in 2024, Dangote Refinery has repeatedly pushed for local marketers to source petroleum products primarily from domestic refineries rather than continue importing refined fuel.

However, the former NMDPRA leadership under Farouk Ahmed consistently resisted any move perceived as creating a monopoly, insisting that allowing a single refinery to dominate supply would undermine competition and threaten Nigeria’s long-term energy security.

That disagreement led to a feud between Aliko Dangote and Mr Ahmed.

Mr Dangote later accused Mr Ahmed of corruption and alleged that the regulator was colluding with international traders and fuel importers to frustrate local refining by continuing to issue import licences.

He also alleged that Mr Ahmed was living beyond his legitimate means, claiming that four of his children were enrolled in expensive secondary schools in Switzerland, raising concerns over possible abuse of office and regulatory integrity.

Mr Ahmed later resigned following the controversy.

Previous lawsuit

In 2024, Dangote Refinery, in suit number FHC/ABJ/CS/1324/2024, asked the court to award N100 billion in damages against the NMDPRA for issuing import licences to some marketers and permitting the importation of petroleum products.

The marketers listed in the suit were NNPC Ltd, Matrix Petroleum Services Limited, AYM Shafa Limited, A.A. Rano Limited, T. Time Petroleum Limited, and 2015 Petroleum Limited.

In the suit dated 6 September 2024, the plaintiff’s lawyer, Ogwu Onoja, asked the court to declare that the NMDPRA violated Sections 317(8) and (9) of the Petroleum Industry Act (PIA) by issuing licences for the importation of petroleum products.

Dangote Refinery argued that such licences should only be issued when a petroleum product shortfall exists.

The refinery also asked the court to declare that the NMDPRA failed in its statutory responsibility under the PIA by failing to encourage local refineries, such as Dangote Refinery.

However, in a counter-affidavit marked FHC/ABJ/CS/1324/2024 dated 5 November 2024 and filed by Ahmed Raji (SAN), the marketers asked the court to dismiss Dangote Refinery’s claims, insisting that competitive practices are essential to Nigeria’s economic health and the viability of the oil sector.

They argued that they were fully qualified to receive import licences from the NMDPRA under Section 317(9) of the PIA.

The defendants further alleged that the plaintiff was attempting to monopolise Nigeria’s petroleum industry by seeking sole control of supply, distribution, and pricing.

In July 2025, Dangote Refinery quietly discontinued the lawsuit challenging the import approvals without publicly stating its reasons, leaving unresolved concerns over market competition and supply dynamics in one of Africa’s largest fuel markets.

READ ALSO: NNPC posts N276 billion profit in March

For decades, Nigeria has relied heavily on imported petrol because its state-owned refineries have performed poorly.

The $20 billion Dangote Refinery, owned by billionaire businessman Aliko Dangote, was expected to end that dependence by supplying refined petroleum products locally.

With an installed capacity of 650,000 barrels per day, the facility is Africa’s largest single-train refinery and is projected to reduce pressure on foreign exchange used for fuel imports significantly.

However, petrol imports have persisted as the refinery continues to ramp up production and distribution capacity, while marketers maintain that domestic output alone has yet to meet national demand fully.

Continue Reading

Trending