Mark Bonifacio

In medtech, portability changes everything. But no matter how advanced the sensors or connectivity—𝐰𝐢𝐭𝐡𝐨𝐮𝐭 𝐨𝐩𝐭𝐢𝐦𝐢𝐳𝐞𝐝 𝐩𝐨𝐰𝐞𝐫, the device fails its mission. As a product development partner, We’ve helped clients across the globe bring 𝐛𝐚𝐭𝐭𝐞𝐫𝐲-𝐩𝐨𝐰𝐞𝐫𝐞𝐝, 𝐩𝐚𝐭𝐢𝐞𝐧𝐭-𝐟𝐚𝐜𝐢𝐧𝐠 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬 to life—where runtime, safety, and regulatory readiness are all non-negotiable. 𝐇𝐞𝐫𝐞'𝐬 𝐰𝐡𝐚𝐭 𝐰𝐞'𝐯𝐞 𝐛𝐮𝐢𝐥𝐭 𝐢𝐧𝐭𝐨 𝐨𝐮𝐫 𝐩𝐨𝐰𝐞𝐫 𝐬𝐭𝐚𝐜𝐤? 1. 𝐃𝐲𝐧𝐚𝐦𝐢𝐜 𝐏𝐨𝐰𝐞𝐫 𝐒𝐜𝐚𝐥𝐢𝐧𝐠 → Firmware that adjusts MCU frequency and voltage based on real-time demand → Peripheral-level sleep/wake control tied to sensor state 2. 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐭 𝐁𝐚𝐭𝐭𝐞𝐫𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 → Smart fuel gauges, thermal protection, and SoC reporting → Redundant power rails for patient-critical pathways 3. 𝐅𝐚𝐢𝐥-𝐒𝐚𝐟𝐞 𝐅𝐢𝐫𝐦𝐰𝐚𝐫𝐞 𝐃𝐞𝐬𝐢𝐠𝐧 → Wake-on-interrupt logic and deep sleep modes → Power domain isolation for noisy subsystems 4. 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐁𝐮𝐢𝐥𝐭-𝐈𝐧 → Compliance with IEC 60601-1/1-11 during early design, not retrofitted → Patient-circuit isolation and fault-tolerant design baked into the architecture From prototyping to production, we’ve learned that 𝐭𝐫𝐮𝐞 𝐩𝐨𝐰𝐞𝐫 𝐨𝐩𝐭𝐢𝐦𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐢𝐬𝐧’𝐭 𝐣𝐮𝐬𝐭 𝐞𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠—𝐢𝐭’𝐬 𝐟𝐨𝐫𝐞𝐬𝐢𝐠𝐡𝐭. Especially in medtech, 𝐩𝐨𝐰𝐞𝐫 𝐢𝐬𝐧’𝐭 𝐚𝐛𝐨𝐮𝐭 𝐜𝐨𝐧𝐬𝐮𝐦𝐩𝐭𝐢𝐨𝐧. 𝐈𝐭’𝐬 𝐚𝐛𝐨𝐮𝐭 𝐜𝐨𝐧𝐟𝐢𝐝𝐞𝐧𝐜𝐞. If you’re building portable devices and need a partner who designs with uptime, compliance, and scale in mind—India is ready. And so are we. #healthcare #medtech #innovation #technology

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Biobeat Technologies Names Raymond W. Cohen as Chairman of the Board of Directors Tel Aviv, Israel & Miami, Florida, Aug. 21, 2025 (Global Newswire) – BioBeat Technologies Ltd, a medical device company that has developed a wearable cuff-less ambulatory blood pressure monitoring system that records and analyzes numerous physiological parameters, today announced the appointment of Raymond W. Cohen as its Chairman of the Board of Directors. Biobeat developed and has received FDA clearance for an easy-to-apply “patch” device that can collect, record and transmit patient data to a cloud-based data center for AI-aided analysis and reporting of physiological parameters, including continuous cuff-less ambulatory blood pressure (ABPM), Sp02, respiration rate, pulse rate, heart rate variability, ECG, temperature and cardiac output. “We welcome Raymond W. Cohen as our new Chairman,” said Arik Ben Ishay, co-founder and CEO of Biobeat. “Ray’s extensive track record in leading, financing and scaling medical technology companies will be invaluable as we look to capitalize on our unique ambulatory technology.” “Biobeat has accomplished what has been an elusive goal for many – a clinically validated and FDA cleared cuff-less ABPM that has the potential to change the use paradigm for measuring ambulatory blood pressure. We see numerous applications for this technology in the new field of renal denervation (RDN) as well as long term monitoring of post-cardiac procedure and CHF patients following discharge from the hospital,” said Mr. Cohen. “I look forward to collaborating with the management team to support the company’s mission to change the way patients are monitored.” Mr. Cohen, an accredited public company director and accomplished medical technology executive, has over four decades of life science industry experience. Cohen currently serves on the boards of several innovative healthcare companies, including Kestra (Nasdaq: KMTS); InspireMD (Nasdaq: NSPR); RxSight (Nasdaq: RXST), Nalu Medical as chairman, Archimedes Vascular as chairman, Tulavi Medical as vice chairman, and Spectrum Vascular as an independent director. Mr. Cohen also serves as a venture partner with Paris-based Andera Partners and Beijing-based Sherpa Capital Partners. About BioBeat Technologies, Ltd BioBeat based in Israel and Boca Raton, FL is a privately held company that has developed wearable, non-invasive cuffless ambulatory blood pressure monitoring technology that enables continuous, blood pressure measurements, respiratory rate, Sp02, ECG, pulse rate, body temperature, stroke volume, cardiac output, systemic vascular resistance and other key physiological parameters. By comparison, unlike traditional ABPM system, BioBeat offers a cuff-less small unobtrusive “patch” device with enhanced patient comfort, especially during sleep while collecting and transmitting real time data to a mobile app. Biobeat’s products are 510(k) cleared by the US Food & Drug Administration.

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New Hampshire Manufacturing News, Last 48 Hours (Sep 1, 2025) From aerospace to sustainability, NH manufacturing strengthens with strategic investments. • GE Aerospace / Hooksett facility Industry: Aerospace & Defense Manufacturing Date: Mar 17, 2025 Impact: GE Aerospace plans a $16M investment in its Hooksett jet engine factory, installing new machines, tooling, and improvements. This supports 800 local employees, enhances precision manufacturing capacity, and reinforces NH’s role in U.S. aerospace supply chains. #NHManufacturing #NHStrong #OPEXInsightPartners Sources: https://lnkd.in/eqh9RA_j

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The future of Medtech is converging in Dana Point in just 30 days. And the capital is showing up. Partnering is now open for LSI USA ‘25, and calendars are already filling up. It’s not too late to jump in. Some key numbers: Innovators: - 360+ Presenting Companies – those that have disclosed financials have already raised $7.97B and are collectively raising another $4.96B right now. Breakdown by stage: - Later Stage: 39 companies, raising an average of $50M - Series C: 30 companies, raising an average of $29M - Series B: 76 companies, raising an average of $21M - Series A: 129 companies, raising an average of $12M - Seed/Pre-Seed: 66 companies, raising an average of $3.6M Geographic breakdown: - United States: 64% of startups | 84% of investors/strategics - Europe: 19% of startups | 10% of investors - Canada/APAC/Israel: 17% of startups (Canada: 20 | APAC: 28 | Israel: 16) But here’s the most important signal: We're on track for a 1-to-1 Investor/Strategic to Startup Ratio. This is good momentum for our industry. See you in Dana Point. Join us: https://lnkd.in/e9SaGB2h

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What would you do if you were 32 years old and handed $150M in responsibility? That’s exactly the position Gary Thomas, the SVP of Manufacturing/Product Development at Onkos Surgical found himself in... leading multiple business units across MedTech with barely a decade of experience under his belt. No manual. No roadmap. Just grit, great people, and an insane amount of determination to not let it fall apart. In our recent episode of 𝐓𝐡𝐞 𝐌𝐞𝐝-𝐓𝐞𝐜𝐡 𝐓𝐚𝐥𝐞𝐧𝐭 𝐋𝐚𝐛 podcast, Gary shared how those early high-pressure years shaped the leader he is today and how the lessons from that time still serve him when product launches go sideways or when team members say, “this can’t be done.” Support. Vigilance. Determination. That’s how you lead when the stakes are high and the clock is ticking. Leadership isn’t about having all the answers. It's about having the backbone when others doubt, and the humility to lean on the people around you. If you're a MedTech leader navigating complex product launches and looking for real talk on what it actually takes to lead under pressure… this is an episode you won't want to miss! Thanks for being a valued guest on the show Gary! -MR 𝐏𝐒 Link to full episode and all the others in the comments. #podcast #medtechtalentlab #leadership #hiring #recruiting

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Avvio Medical Receives FDA Breakthrough Device Designation for Enhanced Lithotripsy System (ELS) We’re proud to share that the Avvio Enhanced Lithotripsy System (ELS) has received Breakthrough Device Designation from the FDA — recognizing its potential to advance the treatment of ureteral stones through microbubble‑enhanced acoustic cavitation lithotripsy. This technology is designed to simplify stone treatment by enabling care outside the operating room, supporting outpatient and ASC workflows, and expanding access for the Medicare‑aged population disproportionately affected by stone disease. It is designed to be used without routine general anesthesia and post-operative stents and our ongoing pivotal US IDE study has already validated patient tolerability of the procedure with oral anxiolytics and topical analgesic gel. We plan to submit a DeNovo for market clearance in early 2026 and a new dedicated category III CPT 0991T code will be effective in January. This milestone validates years of science, teamwork, and commitment to making stone treatment safer, simpler, and more accessible. #AvvioMedical #BreakthroughDevice #KidneyStones #Urology #Lithotripsy #MedicalDevices #Innovation #MinimallyInvasive #UreteralStones #Cavitation #ASC #MedicareAccess https://lnkd.in/gc2bRFsK

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AdvaMed CEO Scott Whitaker has been testifying before the U.S. Senate Finance Committee this morning, making the case for the #medtech #meddevice industry to secure zero-for-zero #tariffs in the Trump administration's #trade negotiations. "If there’s a breakthrough in medical technology, chances are it was developed right here. Tariff policy, if deployed in the wrong way, could put all of that at risk." I have more from Whitaker's testimony on MassDevice. (Link in the comments.)

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🚀 Ready to Navigate the 510(k) Regulatory Maze with Confidence? I’m excited to share AptSkill's latest comprehensive guide: “510(k) Submissions – A Complete Guide for MedTech Professionals” Whether you’re new to the industry or a seasoned MedTech innovator, this free resource covers: ✅ The essentials of 510(k) submissions ✅ Understanding Substantial Equivalence (SE) ✅ When a 510(k) is required (and when it’s not!) ✅ Types of 510(k)s: Traditional, Special, Abbreviated ✅ 21 key sections of a 510(k) ✅ FDA’s review process and tips for success ✅ De Novo pathway insights ✅ Enforcement, compliance, and FOIA explained 🔗 Download the guide here (attach the PDF) #MedTech #FDA #510k #RegulatoryAffairs #MedicalDevices #Innovation #AptSkill

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TechMed vs. MedTech: Why the Merger Still Hasn’t Happened TechMed versus MedTech—a debate that continues to rage as the Venn diagrams inch towards overlap - the long-awaited melding has been slower and bumpier than predicted. Tech hasn’t dominated Medtech, and Medtech hasn’t dominated Techmed. Announcements like the recent Google-Verily move to cease medical-device manufacturing and refocus on AI remind us that repellent forces still predominate over forces of attraction. Few things were launched with the fanfare of Verily; when we were raising VC capital, Canary was told not to bother building a healthcare data business because with Google’s backing, resistance was futile. Didn’t happen. Microsoft, Amazon and others had the same experience. Logic says it will be inevitable. Big Tech has an insatiable need for growth. Healthcare is enormous. The tech majors dwarf all other companies in scope and size – they are the only private enterprises large enough to tackle big healthcare problems. Similarly, it isn’t like medtech executives have been asleep for the last 20 years and have never used the internet or tried LLMs. The easy answer - “different skill sets” - is an oversimplification. Tech companies hired very smart, experienced healthcare people; many of the best and brightest jumped ship to chase a huge opportunity. Medtech companies attracted talented data scientists obsessed with mining vast, untapped health data. Capital, people, knowledge are not the blockers. I think it’s culture. On the Tech side: bold proclamations → spend a fortune for a few years → encounter setback → quietly exit. Nothing prepares you for a Class 3 medical device program or a pivotal drug trial. Dominance cannot be achieved through brute force - you still must invent a piece of biology with highly impactful clinical results. Their odds (currently) are no better than anyone else’s. The house doesn’t always win in healthcare. On the MedTech side: culturally we won’t tolerate the financial and commercial commitment required to shift toward tech. You can’t inch into tech markets - especially those with a consumer (patient) angle. It requires big, upfront spending – even worse, big dollars before you know you have a product. “Move fast and break things” isn’t (and shouldn’t be) our DNA. It is also true that “Network Effects” are not created by budget-conscious, staged market-entry strategies. Tech is not a gross margin story. Bottom line: until senior leadership (and their boards, and shareholders) rewire - regulatory patience/risk for Tech; scale/spend conviction for MedTech - the center won’t hold. The perfect opportunity for outsider disruption.

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💸 MedTech Industry News – Week 28, 2025 💰 #Funding Restore Medical: raises $23m Series B for ContraBand HF device Plexāā | Creators of BLOOM⁴³: adds $4.5m to fund BLOOM43 U.S. launch Neuros Medical, Inc.: lands $56m Series D for Altius nerve-stimulation Adtec Healthcare Limited: secures $12m for next-gen cold-plasma device PIUR IMAGING GmbH: €5.6m growth round to scale 3-D ultrasound FluidAI Medical: $2m Canadian grant accelerates Stream & Origin Plasmacure: €6m Series A to advance cold-plasma wound therapy Amotio Health: raises €810k for revision-surgery tech Alva Health Inc.: wins $500k NSF grant for wearable stroke monitor Lucida Medical: £2.25m SBRI funds Pi prostate-MRI AI rollout Ebenbuild: €2.3m EIC grant to scale lung-twin platform The Blue Box Biomedical Solutions: Unconventional Ventures’ continued backing fuels development of its 88%-sensitivity urine-based breast-cancer test. 🏛 #Regulatory MatOrtho Ltd: ReCerf ceramic hip resurfacing gains CE mark Mendaera, Inc.: Focalist handheld robot wins 510k Exactech: Equinoxe scapula reconstruction wins 510k Hypervision Surgical: Hypersnap AI hyperspectral platform wins 510k Synchrony Medical: LibAirty airway-clearance system cleared by FDA Boston Scientific: Farapulse PFA label expanded by FDA Hilo by Aktiia: G0 cuff-less BP monitor is first OTC BP device cleared Morphic Medical: obesity device secures CE mark Caranx Medical: surgical-robot software cleared by FDA ArteraAI: prostate-cancer AI wins FDA Breakthrough status Abbott: TriClip TEER gains Medicare outpatient coverage 𝗗𝘆𝗺𝗶𝗰𝗿𝗼𝗻 Granted IDE Approval for Triadyme-C Artificial Disc 🧪 #ClinicalTrials CorWave: first human implant of wave-membrane LVAD completed Medtronic: first patient treated in Spyral Gemini hypertension pilot CorFlow: MOCA-II IDE pivotal trial approved by FDA PanTher Therapeutics chemo-patch enters human trial Miach Orthopaedics, Inc.: BEAR ACL implant shows positive data Radical Catheter Technologies: 8F guide catheter posts strong early results MediView XR, Inc. XR: 104-patient XR90 holographic-guidance study begins 🤝 #M&A Innovia Medical: buys Grace Medical & Hurricane Medical Alcon: to acquire LumiThera dry-AMD photobiomodulation device Companion Spine: to acquire Coflex, CoFix & Paradigm Spine assets Gilde Healthcare: merges Artinis & NIRx into global fNIRS leader 💡 #Innovation SoundHealth: Android app rolls out for SONU tinnitus band Highridge Medical: activL lumbar disc launches in U.S. InspireMD: CGuard Prime carotid stent debuts in U.S. 𝗦𝗦 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀: first robotic telesurgery for weight-loss case OraSure Technologies, Inc.: launches proteomics blood-collection device MMI - Medical Microinstruments, Inc.: first use of NanoWrist instruments & Synaptix platform Leaflet Solutions: launched by Sectoral to develop Scalarto catheter 📩 If you're building in #MedTech I am watching. DM us to share your update or milestone.

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Big news in the Medtech world. A recent ruling has made waves, and it comes with a hefty price tag. Last month, a jury found Johnson & Johnson subsidiary, Biosense Webster, guilty of violating antitrust rules by withholding support from hospitals that bought reprocessed catheters. And just this Thursday, District Judge James Selna tripled the damages to a staggering $442 million, as allowed under antitrust law. Here's the backdrop: Innovative Health filed the lawsuit back in 2019, asserting that J&J had monopolized the heart-mapping catheter market and tied support for its Carto 3 mapping system to purchases of mapping and ultrasound catheters. The jury found J&J in violation of both the Sherman Act and California's Cartwright Act. Daniel Vukelich, CEO of the Association of Medical Device Reprocessors, hailed the ruling as "a seismic result" and a clear signal to device manufacturers against employing anti-competitive tactics. According to Vukelich, this judgment underscores the commitment to cost savings, sustainability, and patient care. Meanwhile, J&J plans to appeal the decision but will comply with the ruling and any court-ordered relief in the interim. A spokesperson from the company stated, "We strongly disagree with the jury's verdict and believe it will not withstand appellate review." The implications of this ruling are massive. It could reshape competitive practices and compliance standards within the medical device industry. It also serves as a crucial reminder that ethical business practices are not just a regulatory requirement—they're central to the mission of improving patient outcomes and sustaining healthcare systems. Let's hear your thoughts! How do you think this ruling will impact the future of Medtech, especially in the realm of reprocessed devices? #Medtech #HealthcareInnovation #AntitrustLaw

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The biggest challenge after FDA clearance? Adoption in the market. Never underestimate how difficult it is to change clinical practice and gain hospital system approval. Here’s a few things I believe we did well. I can now reflect on our journey bringing a product from concept to exit. My advice – start incorporating these into your go-to-market roadmap now. 1. Engage with early pilot sites – Identify 3–5 high-volume labor & delivery units willing to pilot your device. Their feedback and case studies will shape your broader rollout. A successful pilot can lead to internal approval, ongoing sales, and the development of reference sites more broadly in the market. 2. Build a Clinical and Economic case – Demonstrate not just improved clinical outcomes, but also cost savings, efficiency gains, and alignment with quality metrics hospitals care about. You need to appeal to clinicians (end user) but also group purchasing committees (interested in the finance side). 3. Leverage KOL networks and relationships - Engage respected OB/GYNs, nurse leaders, and MFM specialists who can advocate for your device within professional groups. One simple tactic we used – at national conferences, we looked for opportunities to showcase our product (speaker opportunities, product theatres, innovation demos, skills stations etc). 4. Plan your distribution infrastructure - Whether you use a direct team or independent reps, your sales channel must be trained, incentivized, and equipped with the right messaging. There will likely be contracts to negotiate (pricing, territories, obligations etc) so these discussions should commence before your US launch. We used a mix of direct and distribution which worked well for us in a cost-effective way.   5. Invest in training & support - Adoption often hinges on ease of use. Hands-on training and clear protocols can make the difference between a one-off trial and long-term utilisation. For example, we developed an online training platform for clinicians. Regular on-site training was clearly the priority, but the pre-training remotely allowed for a shorter learning curve. Better trained clinicians meant a better experience using the device for the first time. FDA clearance allows for US market entry – but your commercialisation strategy will ultimately determine your success in the market. If an acquisition is on your roadmap, commercial traction is one of the most important value drivers. There’s no easy way to do this – it’s getting in front of clinicians every single day and putting in the work. I’m just grateful I had the time to do this before having kids. Instead of business trips, its mainly trips with them now. And a lot of ice cream. If you’re working on an obstetric innovation and want to discuss US adoption strategies, let’s connect. #Business #Journey #StartUp #MedicalDevices #WomensHealth #Obstetrics #FDAClearance #Commercialization

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The 39th Episode of "The MedTech Experience" long-form podcast is now available! Teresa Prego, CEO of EpiWatch, and Giovanni Lauricella, CEO of Lifeblood, continue building this series that brings to life the stories and lives of those who take on the MedTech industry everyday in their own way! Link to the full episode: www.lifeblood.com/podcast In this entertaining and educational episode...your host, Giovanni Lauricella, interviews Teresa Prego, CEO of EpiWatch. Teresa shares her story of building early stage companies. Giovanni and Teresa discuss the acquisitions and integration challenges, retail vs reimbursed medical devices, wearables and neuromodulation, building a company that can be acquired, and more.   You can learn more about EpiWatch and their wearable technology for seizure detection at www.epiwatch.com   This episode is sponsored by Prolucid Technologies, a software commercialization company based out of #Toronto, #Canada. To learn more about Prolucid and the services they offer visit www.prolucid.ca Chapter Timeline: 00:00 Introduction 00:01:48 Marathons 00:15:53 Soccer, Coaching, and Community 00:22:10 Who is Teresa Prego? 00:46:11 The Value of an MBA 01:01:54 Acquisitions and Integration Challenges 01:18:05 Building a Company That Can Be Acquired 01:24:37 Retail vs Reimbursed Medical Devices 01:29:43 The Consumer-Regulated Device Conundrum 01:36:13 Lobbying for MedTech 01:41:53 Wearables and Neuromodulation 01:49:30 International Expansion and Cultural Challenges 01:55:35 EpiWatch 02:08:16 MedTech Innovator 02:15:00 MedTech in #Boston and #Baltimore 02:23:51 Prolucid Technologies Link to the full episode: www.lifeblood.com/podcast This series is made possible by "The Believers." Our gratitude goes to: Martin Gomez and Goodwin, Darcy Bachert, Chris Kennedy and Prolucid Technologies, Kevin Saem, Ph.D., of Zapyrus, Michael Byrne, Nicholas Hoffman and Minnetronix Medical...and, Benjamin Sanchez, Head of Operations at Lifeblood! Thank you! With love for Teresa Prego and "The Believers" who enabled The MedTech Experience Podcast to come to life, Giovanni Lauricella CEO of Lifeblood www.lifeblood.com #Lifeblood ... The Executive Search Firm for small and medium-sized MedTech Companies.

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