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The Journey from Prototype to ClearanceBuilding a medical device is fundamentally different from standard software development. This week on Build Mode, host Isabelle Johannessen sat down with Robhy Bustami, co-founder and CEO of BioticsAI, to discuss the arduous path from a $100,000 prototype to FDA clearance. Bustami, a Startup Battlefield winner, detailed how his team is building an AI copilot for ultrasound designed to detect fetal abnormalities. The conversation revealed that the traditional startup mantra of 'move fast and break things' is obsolete in the medical sector, replaced by a necessity for extreme precision and coordination.Market Validation and Resource AllocationThe episode provides a strategic look at the 'data' driving medtech success. BioticsAI's recognition as a Startup Battlefield winner serves as a key validation of their technology's potential. However, Bustami emphasized that the primary data point for founders is not just market traction, but the successful navigation of complex regulatory pathways. This requires a significant reallocation of resources—shifting focus from rapid feature deployment to ensuring safety, reliability, and compliance with FDA standards.Shifting the MedTech CultureThe core impact of this discussion lies in the cultural shift it highlights for the industry. As timelines for FDA approval remain uncertain, the ability to maintain team morale and investor confidence becomes a critical operational metric. Bustami noted that building in a regulated industry requires a foundation of trust rather than speed. This signals a broader trend where medtech startups must balance the pressure of hyper-growth with the ethical and legal responsibilities of patient safety.The Future of AI in Healthcare RegulationLooking ahead, the medtech landscape will likely see a consolidation of companies that prioritize long-term compliance over short-term hype. As more AI copilots enter the market, the winners will be those founders who master the art of 'slow and steady' innovation. The next wave of medical breakthroughs will depend not just on algorithmic superiority, but on the ability to build sustainable organizations capable of weathering the regulatory storm.

The Challenges of FDA Approval Surviving the long road to FDA approval isn’t just about building great technology — it’s about keeping your team motivated, finding the right investors, and learning how to operate when timelines are uncertain. Lessons from BioticsAI This week on Build Mode, Isabelle Johannessen sits down with Robhy Bustami, co-founder and CEO of BioticsAI, a Startup Battlefield-winning company building an AI copilot for ultrasound to help detect fetal abnormalities. From a $100,000 prototype to FDA clearance, Bustami shares what it actually takes to build in one of the most regulated industries in the world. Building a Medtech Startup In this episode, they break down what it really looks like to build a medtech startup, including where you can’t “move fast and break things” and that every milestone takes time, coordination, and trust. Key Takeaways Team motivation is crucial during the long FDA approval process Finding the right investors is essential for medtech startups Adaptability is key when dealing with uncertain timelines Future Outlook As the medtech industry continues to evolve, startups like BioticsAI will play a critical role in shaping the future of healthcare technology. With the right approach and mindset, these companies can overcome the challenges of FDA approval and make a lasting impact.

The Kremlin's Shadow in Mali: A Coordinated Assault on StabilityBamako is under siege following a series of coordinated explosions that have left the nation's military leadership in disarray.The Coordinated Assault on BamakoOn April 25, Mali's capital was rocked by a wave of coordinated attacks. The violence was not limited to the capital but spread across the country, indicating a highly organized operation.April 25: Explosions rock Bamako and coordinated attacks across Mali.Target: The residence of the Defense Minister.Outcome: Defense Minister killed, along with his wife and children.Strategic Losses and Leadership VoidThe death of the Defense Minister represents a catastrophic strategic loss for the current administration. The fact that the military leadership briefly disappeared from view suggests a breakdown in command and control during the crisis.Geopolitical Implications and External InfluenceThe title of the episode, "How rebels teamed up to shake Mali and the Kremlin’s grip," hints at a complex geopolitical maneuver. This attack suggests that rebel groups are not acting in isolation but are coordinating efforts to destabilize the government. The involvement of external actors, potentially including the Kremlin, adds a layer of complexity to the conflict, turning a local security crisis into a potential regional flashpoint.The Future of Mali's Internal SecurityWith Bamako under siege and key military figures eliminated, the security situation in Mali is likely to deteriorate further. The coordinated nature of the attacks implies that the rebels have significant resources and planning, posing a severe threat to the regime's survival.

The Palantir Manifesto ControversyJust weeks after publishing a manifesto on X that implied some cultures are inferior to others, described by one UK MP as the "ramblings of a supervillain," the US spy tech company Palantir faces growing calls for a ban in Australia. The company, which has significant government contracts in Australia, now claims it is "just a software company" amid mounting public and political backlash.Cultural Statements Spark Global ConcernEarlier this month, Palantir published a manifesto on X, arguing the benefits of American power and stating: "Some cultures have produced vital advances; others remain dysfunctional and regressive." This public pronouncement, combined with concern over Palantir's software being used by ICE immigration enforcement in the United States and the Israeli military, has led to calls in Australia and the UK for governments to cease using Palantir in their operations.Financial Footprint in Australian GovernmentState and federal contracts with Palantir in Australia have reached nearly $80m, with federal investment in the company reportedly more than $160m. Federal agencies including the financial intelligence agency Austrac and the defense department have spent an estimated $60m in contracts with Palantir. Australia's sovereign wealth fund, the Future Fund, holds $100m worth of shares in the company. In Victoria, the prison system has spent nearly $20m on Palantir contracts since 2012, with a current contract valued at $9m and not due to expire until 2028.Government Response and Company DefenseAustralian Greens senator David Shoebridge has called for a "blanket ban on all new contracts with Palantir, pending a comprehensive public audit of their existing Government agreements." In response, a Palantir spokesperson emphasized that the company is "proud its software supports the Australian defense force and other government agencies" and claimed, "We don't collect or monetize data – we simply provide the tools to help customers organize and understand their own information."Regulatory Scrutiny and Future ImplicationsPalantir has identified Australia as a lucrative market for its surveillance software, achieving "protected level" in the Australian Signals Directorate's information security program. However, questions remain about compliance with the Commonwealth supplier code of conduct, which requires suppliers to avoid bringing the federal government into disrepute. With the recent termination of its lobbying relationship with Cmax Advisory and growing public concern, Palantir's future in Australia's government sector faces significant uncertainty as political pressure mounts for greater transparency and accountability.

Saudi PIF Announces End of Funding After the 2026 SeasonThe Public Investment Fund (PIF) confirmed that its financial support for the breakaway LIV Golf league will stop at the close of the 2026 season. In a statement, PIF said the “substantial investment required over a longer term is no longer consistent with the current phase of PIF’s investment strategy.”New LIV Golf Board Targets a Multi‑Partner Investment ModelGene Davis of Pirinate Consulting Group and Jon Zinman of JZ Advisors have been appointed to a newly created board, with Davis serving as chair. Their mandate is to secure long‑term financial partners to replace Saudi capital, while a committee of independent directors will explore strategic alternatives beyond the PIF horizon.Financial Footprint: $5.3 bn Spent Since Launch$1 bn allocated to marquee contracts for players such as Bryson DeChambeau, Brooks Koepka, Phil Mickelson, Cameron Smith and Jon Rahm.$5.3 bn spent by LIV Golf from its 2022 launch; projected to reach $6 bn by year‑end.$30 m prize fund per tournament.Goal for 10 of 13 teams to be profitable this year.Implications for the Global Golf LandscapeThe funding withdrawal reshapes the power balance between LIV Golf and the established PGA Tour. Without PIF backing, LIV must prove its franchise‑team model can attract alternative capital, a challenge that could affect player retention, especially for top signings like DeChambeau and Rahm. The PGA Tour, meanwhile, continues to negotiate pathways for former LIV players, offering limited‑time returns but with strict conditions.Outlook: Funding Strategies and Player RetentionAnalysts expect LIV Golf to pursue a consortium of private investors, media rights deals, and possibly a public‑stock component to sustain operations beyond 2026. Success will hinge on delivering consistent profitability across its teams and maintaining the allure of its $30 m prize pools. If alternative financing falls short, the league may face a talent exodus as contracts expire, potentially accelerating a convergence with the PGA Tour’s ecosystem.

The Lead-Up to the 76th FIFA Congress The 76th FIFA Congress is set to take place in Canada, with leading figures of the football world gathering to discuss key issues. The meeting will be overshadowed by the US-Israeli war on Iran and its team's participation in the World Cup. Iranian Delegation's Absence The Iranian delegation will not attend the congress due to issues with Canadian immigration officials. Iranian football officials turned back upon arrival at Toronto's Pearson airport, citing 'unacceptable behaviour of immigration officials.' Human Rights Concerns at the World Cup Human rights group Amnesty International has called on FIFA President Gianni Infantino to use the congress to declare how human rights will be safeguarded at the World Cup. Amnesty urged Infantino to detail 'how he will ensure that the world's biggest sporting tournament does not become a stage for repression and a platform for authoritarian practices.' The #SaveTheCaps Campaign Fans are using the congress in Vancouver to bring attention to the #SaveTheCaps campaign against the potential relocation of the Major League Soccer team Vancouver Whitecaps to Las Vegas. Vancouver Southsiders, the self-proclaimed 'largest support group' of the Whitecaps, has called for a public demonstration ahead of Thursday's congress. What's on the FIFA Congress Agenda? The annual FIFA Congress brings together representatives of all 211 member associations to make key decisions regarding world football governance, finances, and regulations. Thursday's congress will focus on operational and financial issues related to the 48-team World Cup – the largest ever tournament.

The Riyadh Summit: A Strategic ReassessmentGulf leaders gathered in Riyadh for their first in-person meeting since the outbreak of the US-Israel war with Iran. The agenda extended beyond security protocols to prioritize expediting five major strategic projects designed to deepen economic ties and strengthen collective resilience.Accelerating the GCC Integration AgendaUnder the umbrella of the Gulf Cooperation Council (GCC), these initiatives span transport, energy, water security, and defense. The shift in priority is driven by the realization that these projects are no longer merely economic aspirations but critical security necessities.Unified Gulf Railway Network: A 2,117km network connecting all six member states, designed for passengers and freight at speeds up to 200km/h.Electrical Interconnection Grid: A successful network allowing power sharing, reducing costs and providing emergency backup.Water Interconnection System: A proposed network to share supplies during shortages, addressing vulnerability to Iranian strikes on desalination plants.Oil and Gas Pipeline Integration: Streamlining energy flows and diversifying transport routes to reinforce collective market weight.Joint Ballistic Missile Early Warning System: An integrated defense network using satellite sensors to detect missile launches in real-time.The Economic Case for Regional InterconnectionThe electrical interconnection grid serves as the benchmark for regional integration. Since its full integration in 2014, the system has generated $3bn in economic savings and handled nearly 3,000 emergency support cases through cross-border transfers. This track record proves that shared infrastructure can significantly lower costs and improve reliability.From Sovereignty to Collective ResilienceThe impact of these projects extends beyond infrastructure; it represents a fundamental shift in political calculus. Thomas Bonnie James, a Gulf studies expert at the University of Aberdeen, notes that Iranian strikes have converted these projects from economic aspirations into security necessities. The region is moving toward an approach where "civilian resilience is a collective problem requiring a collective solution."The New Era of Gulf Strategic AutonomyThe geopolitical environment is forcing a faster pace of integration. As James suggests, the difficulty of aligning "six sovereignties" is being overcome by the urgent need for survival. The future outlook suggests a rapid acceleration of these projects, particularly cross-border freight corridors and defense networks, as the GCC seeks to insulate itself from external shocks.

The LeadDespite US Secretary of Defense boasting of rapid military success against Iran, the Pentagon has suffered significant losses with military equipment worth between $2.3bn and $2.8bn destroyed in the ongoing conflict. The most notable incidents include the destruction of a $700m radar aircraft and multiple missile defense systems.The Event DetailsThe conflict began on February 28, with US officials initially claiming rapid success. However, Iran's response has been more effective than anticipated. On March 26, US Secretary of Defense Pete Hegseth made a bold claim at a televised Cabinet meeting: "Never in recorded history has a nation's military been so quickly and so effectively neutralised."The very next day, Iran retaliated by firing missiles and drones that struck a US base in Saudi Arabia, wounding several US soldiers and destroying a $700m E-3 AWACS/E7 radar surveillance aircraft. This airborne command center, capable of detecting aircraft and missiles hundreds of kilometers away, was destroyed at Prince Sultan airbase in eastern Saudi Arabia.Additional losses include at least one THAAD missile defense radar system worth between $485m and $970m, and three F-15 jets lost to friendly fire in Kuwait in early March.The Data AnalysisThe Washington, DC-based Center for Strategic and International Studies (CSIS) has conducted the first detailed tabulation of US military losses in the conflict. Senior adviser Mark Cancian, a retired US Marine colonel with over three decades of military experience, calculated the losses at between $2.3bn and $2.8bn.Notably, this estimate does not include losses incurred at US bases in the region or specialized equipment and naval assets. Cancian noted that assessing damages to bases has been challenging due to US government restrictions on satellite imagery from Planet Labs since February 28.The CSIS analysis reveals that while the US has achieved some operational victories, the financial cost has been substantial. The most expensive single loss was the E-3 AWACS/E7 aircraft at $700m, followed by the THAAD radar systems.The Impact AnalysisThe losses have significant strategic implications for US military posture in the Middle East. Omar Ashour, professor of security and military studies at the Doha Institute for Graduate Studies, suggests that while the US has disclosed some figures, it cannot afford full transparency for political reasons."At this point, I don't think the Trump administration would want to be looking like losing equipment [and] personnel," Ashour told Al Jazeera, adding that there might be a "price" to pay "at the [midterm] elections in November."The conflict has also affected US relations with Gulf nations. Iran's decision to strike Gulf nations, not just US bases, backfired by driving them closer to the United States, according to Cancian. Additionally, the US failure to keep the Strait of Hormuz open has been a humbling reminder of naval unpreparedness.Despite these losses, Ashour notes that Iran has also suffered severe damage to its military. The US-Israeli operation has degraded Iran's conventional military architecture but has not eliminated its missiles, munitions, and drones.The PredictionLooking ahead, experts suggest that the US may need to reassess its strategy in the region. The current US troop deployment constitutes less than a tenth of the force used to invade Iraq in 2003, and the US lacks the number of aircraft carriers previously deployed.Cancian, reflecting on his military experience, noted that the US has been planning for potential conflicts with Iran for 45 years, including amphibious operations to capture Qeshm Island. However, "when the US launched the current war, they didn't have the forces in place."The conflict may ultimately follow historical patterns where operational victories do not translate to strategic success. As Ashour points out, "In Vietnam, they did a series of operational victories. In Afghanistan, they did. But then [they suffered] the strategic loss in the end."With midterm elections approaching, the Trump administration faces pressure to demonstrate progress toward its proclaimed goals of regime change and denuclearizing Iran, even as the financial and strategic costs continue to mount.

The Lead: A New Maritime Flashpoint EmergesThe Panama Canal has emerged as the latest maritime flashpoint, with the United States and China exchanging barbs in recent weeks over influence in what is one of the world's most important shipping routes. This dispute comes amid broader tensions over the Strait of Hormuz, raising concerns about disruptions to global trade and the potential erosion of international maritime laws.The Event Details: Accusations and Denials Over Canal ControlIn a joint statement with Bolivia, Costa Rica, Guyana, Paraguay, Trinidad and Tobago, the US condemned what it called "China's targeted economic pressure" and actions that have "affected Panama-flagged vessels." The countries accused China of detaining Panama-flagged ships in its own ports, claiming these actions are "a blatant attempt to politicise maritime trade and infringe on the sovereignty of the nations of our hemisphere."China strongly denied the allegations, calling them "hypocritical" and accusing the US of politicizing global commerce and undermining sovereignty. Lin Jian, a spokesperson for China's Ministry of Foreign Affairs, asked rhetorically: "Who occupied the Panama Canal for a long time, invaded Panama with its military, and arbitrarily trampled on its sovereignty and dignity?"The crisis stems from Panama's Supreme Court scrapping in January a longstanding concession held by a Hong Kong-linked company to operate the Balboa and Cristobal ports. This decision came amid sustained US pressure on Panama to curb Chinese influence around the canal.The Data Analysis: Global Trade at RiskAnalysts have warned that any disruption to the canal, even temporarily, could "disrupt global trade significantly." According to Ferdinand Rauch, a professor of economics at the University of St Gallen in Switzerland, "It would lead to temporary supply bottlenecks, stock market volatility, inflationary upward pressure and could dampen global GDP measurably if prolonged."The Panama Canal accounts for about six percent of global trade, while the Strait of Hormuz, through which one-fifth of the world's oil and liquefied natural gas (LNG) supplies are shipped during peacetime, has been effectively closed since the US and Israel started bombing Iran on February 28. Currently, some 2,000 vessels are stranded at either end of the strait, while others have been rerouted, come under fire or even been seized.The Impact Analysis: Erosion of Maritime NormsThese frictions point to a broader shift in international shipping, demonstrating that major powers are increasingly willing to contest control of global shipping lanes. Abdul Khalique, a professor at Liverpool John Moores University in the UK, said "rising geopolitical rivalry" is increasingly "spilling into maritime chokepoints, from the Panama Canal to the Strait of Hormuz."The situation has raised questions over whether longstanding international laws governing the world's seas are beginning to unravel. James Kraska, Charles H Stockton Chair of International Law at the US Naval War College, noted that while the ongoing maritime crisis between the US and Iran is unlikely to become a permanent feature, strong international opposition to the unilateral closure of major sea lanes will be a key factor driving a resolution.The Prediction: Adapting to a Volatile Maritime FutureWhile experts disagree on whether this represents a "new normal" for global shipping, there are signs that governments and firms are "already adapting pragmatically: diversifying supply chains, revising risk premiums, increasing naval coordination, and investing in alternative routes," according to Khalique.UPF Barcelona School of Management professor Stephan Maurer warned that the consequences of disruption to or even closure of the Panama Canal for global trade "could be very grave, depending on the degree of disruption." Trade would adapt, but alternatives would greatly increase distances to be covered, with South American countries being most impacted, while the US and Canada would also be "severely affected."