Archimedic

Got your #RiskManagementPlan in-place? Download ours for free at #OpenQMS In the fast-paced world of medical device development, starting your risk management plan early is not just a best practice—it can avoid a disaster. By integrating risk management from the very beginning, you can prevent costly rework, streamline your development process, and ensure a smoother path to market. ?Don't wait for problems to arise ?Tackle them head-on with proactive risk management. Your future self (and your budget) will thank you. Want access? Head over to the Archimedic website and click the OpenQMS button. From there, you’ll have access to all our native forms and templates. Plus, we’ll share video tips on how to put them into practice. #MedicalDevices #RiskManagement #ProductDevelopment #qms Mark Torres Christopher Scholl M. Alexander Shaw Rightley McConnell Eric Sugalski

?? Stop Waiting for Problems—Preventative Actions Are Your Competitive Edge. In medical device development, Corrective and Preventative Actions (CAPA) are supposed to work hand in hand. But let’s be honest—most companies fixate on the "CA" (Corrective Action). It’s reactive. It’s tangible. And too often, it’s punitive. ? Find the problem. ? Fix the problem. ? Document the fix. But here’s the thing—if you’re always reacting, you’re already behind. The real opportunity lies in Preventative Actions (PA)—identifying risks and implementing improvements before issues arise. It’s not just about compliance—it’s a strategic advantage: ?? Faster market access by reducing delays from unexpected issues. ?? Lower costs by preventing expensive recalls and redesigns. ?? Enhanced reputation by building trust through reliability. So why do so many MedTech companies wait for problems to happen? It’s time to shift the mindset: ? Treat CAPA as a growth tool, not just a compliance checkbox. ? Prioritize prevention, not just correction. ? Build a culture that values proactive risk management. The companies that invest in prevention today will lead the market tomorrow. Is your team focusing on Preventative Actions—or just cleaning up the mess? #MedTech #CAPA #QualityManagement #RiskPrevention #Innovation M. Alexander Shaw Christopher Scholl Eric Sugalski Mark Torres Rightley McConnell

Are User Needs and Design Inputs the same thing? The conventions used to write User Needs (UNs) and Design Inputs (DIs) vary across medical device companies—no surprise since FDA and EU MDR don’t explicitly define how to document them. But a key takeaway from FDA guidance is this: ? User Needs DRIVE Design Inputs ? Validation PROVES we designed the right product ? Verification PROVES we designed the product the right way At Archimedic, we craft UNs from the user’s perspective, not the device’s performance. And then consider how we’ll validate this need. Our method? ?? User Needs: “A user needs to accomplish something specific with the device.” ?? Design Inputs: “The device shall deliver functionality.” EXAMPLE: ?? UN: “The user needs to be able to clean the device after each use with hospital-grade disinfecting wipes.” ?? DI: “The device exterior shall be compatible with hospital-grade disinfecting wipes.” This structured approach aligns with INCOSE best practices and ensures seamless V&V. Stay tuned for our next blog on how we integrate V&V from the start! #MedicalDevices #DesignControls #Validation #Verification #ProductDevelopment Christopher Scholl M. Alexander Shaw Rightley McConnell Eric Sugalski

Introducing OpenQMS — Because Quality Management is a black box in MedTech. ? No one goes to school for it. ? Every company does it differently. ? Every country has its own rules. So how do newcomers get up to speed? OpenQMS = Archimedic’s ISO 13485 Certified Quality Management System, opened up to you. We’re giving you free access to forms, templates, tools, and video instructions to make QMS more clear, actionable, and efficient. ?? Follow Archimedic's Page — we’ll be sharing essential QMS resources in the coming days. ?? Want access right now? Head to the Archimedic homepage and click #OpenQMS in the upper right corner. Let’s shine some light on the black box of MedTech Quality. ?? #MedTech #QualityManagement #OpenQMS #Archimedic M. Alexander Shaw Rightley McConnell Christopher Scholl Mark Torres Robert LaClair Jr Eric Sugalski

3 Tips on MedTech Fundraising. (From a CEO that just oversubscribed her round) Raising funds for a MedTech startup isn’t just about pitching—it’s about strategy, relationships, and knowing what makes investors say “yes.” I recently spoke with Sydney Robinson, CEO of Vessl Prosthetics Inc., who successfully oversubscribed her Pre-Seed round. The attached article highlights the take home points. Plus, it includes a link to the full video conversation. TLDR; Here are three lessons from her journey: ?? 1. Seek Advice, Not Just Funding Cold-pitching rarely works. Instead, Sydney approached investors with curiosity—asking for advice, not a check. This built trust, opened doors, and ultimately led to funding from investors who helped shape her strategy. ?? 2. Stay True to Your Vision, But Adapt the Messaging Every investor, regulator, and clinician has a different perspective. Instead of changing direction with every piece of feedback, Sydney stayed firm on Vessl’s vision but tailored the story to resonate with each audience. ?? 3. Find the Tipping Point That De-Risks the Investment Investors back opportunities that feel inevitable. For Vessl, a newly available reimbursement code opened revenue opportunities overnight—an unexpected tailwind. But their team also put in the work to prove usability and demand, aligning milestones with investor confidence triggers. Got Tip 4 to share? Drop it in the comments! ?? Archimedic Robin Hood Ventures

If you're at MD&M West, drop by booth 874 to meet with Rightley McConnell and M. Alexander Shaw.

Angel Investing in MedTech: 7 Reasons Startups Fail Due Diligence It’s been just over a year since I joined Robin Hood Ventures as an angel investor. And if there’s one thing I’ve learned from diving deep into due diligence, it’s this: the same red flags kill deals over and over again. ?? Here's a brief article on the topic. TLDR; If you’re a MedTech founder raising funds, avoid these common pitfalls: ?? 1. Is the Unmet Need Real? It’s not about what you believe—it’s about cold, hard data. Clinician testimonials aren’t enough. Are providers actively seeking alternatives, or is the status quo good enough? Investors will ask independent experts. Be ready. ?? 2. Is the Market Actually There? TAM-SAM-SOM slides mean nothing if your bottom-up math doesn’t check out. How many real customers exist? What’s a justifiable price point? How often will they use it? If you don’t do the math, investors will—and they won’t like surprises. ?? 3. Will Anyone Pay for It? Better isn’t enough—it has to be worth paying for. Show early willingness-to-pay signals: LOIs, purchasing department feedback, or economic impact data. No clear reimbursement strategy? That’s a problem. ?? 4. Can You Land the Next Round? Most MedTech startups need a $10M+ round to reach an exitable milestone. If VCs aren’t already circling, angels won’t bite. Have you socialized your deal with bigger investors? DD teams will check. ?? 5. Are There Real Exit Opportunities? Who’s actually buying companies like yours? What stage are they acquiring at? If your only M&A comp is from a decade ago, that’s a red flag. Be clear on how and when you’ll exit. ?? 6. Are Your Deal Terms Realistic? Overpriced startups don’t even make it past screening. Work backwards: What return do angels & VCs need? What valuation makes sense based on real exit comps? If your numbers are wishful thinking, expect a quick pass. ?? 7. Are You As Far Along As You Claim? Every startup claims they’re “almost there.” Investors will dissect your tech, regulatory, and clinical milestones. If you’re not ready, own it. Transparency builds trust—overpromising destroys it. ?? Final Takeaway You don’t need all the answers—but strong startups: ? Have deeply researched these issues ? Present data-backed responses ? Show proactive risk mitigation Get ahead of these questions, and you’ll make your MedTech startup far more fundable. What’s been your biggest lesson from MedTech fundraising? Drop it in the comments! ??

Heading to MD&M West next week? Stop by Booth 874 to meet with M. Alexander Shaw and Rightley McConnell. Hope to see you there! MD&M Trade Shows

Speed vs. Certainty in MedTech Which one really drives success? Most startups chase speed: - Build a minimum viable product - Rush to design freeze - Push through V&V - Hire sales rep and scale But speed often leads to the redo loop—and the redo loop takes far longer than a path focused on certainty. What does certainty look like? - A feedback-driven approach - Pressure-testing problem statements - Deeply understanding customer needs - Consistently gathering user feedback - Seeking out the "no" from stakeholders Before making speed your priority, consider what you might be sacrificing. In MedTech, certainty is always the better bet. #medtech #medicaldevices #mvp Archimedic

The stability of an ampoule. With the usability of a prefilled syringe. Meet Ampulis—the drug delivery tech we're building out in the open. Who is it for? 1. HCPs delivering anesthesia drugs: Most perioperative anesthesia drugs are pre-prepared by hospital pharmacies. But in 5% of cases, emergency anesthetics are needed quickly. Anesthetics often require ampoule stability due to volatility. When every second counts, ease of use and speed are essential. 2. HCPs and patients administering oncology drugs: Oncology drugs are cytotoxic, posing safety challenges for healthcare professionals. As more treatments move from hospitals to homes, patients and providers need a safe, reliable delivery device for these potent drugs. Got questions or comments? Drop them below—we’d love your feedback! #pharma #drugdelivery #medtech Archimedic