Sponsored By Medical Industry Trends
The Future of Medical Device Design & Development Is AI
Even small and midsize medtech teams can put AI to work and win. Ultraviolet CEO Brian Charlesworth is proving it by helping companies integrate AI across R&D, operations, and product decisions-without eight-figure budgets.
At a Glance
- Smaller firms can spot profitable niches that larger manufacturers overlook.
- AI cuts cycle time by filtering data, running simulations, and generating bills of materials in hours-not weeks.
- It's personal for Charlesworth, who's using AI to improve devices for children with rare conditions.
Why small teams can win
Big manufacturers chase the biggest markets. If you read the trends in FDA filings, you'll see heavy investment in imaging and other high-ROI categories where pattern recognition has clear upside. That concentration leaves a long tail of opportunities open to focused teams with faster decision loops.
The move: use public signals like 510(k) summaries and the FDA's AI/ML device listings to map where the giants are clustering-and where they aren't. Then build for the gaps with tight scope and undeniable clinical utility.
FDA: AI/ML-enabled medical devices
From data flood to design decisions
Product teams drown in PDFs, material sheets, and test data. Charlesworth's approach: feed the facts to an AI system that can read materials safety data, engineering specs, product requirements, and clinical constraints-and return only what matters for the next design move.
On a recent device, Ultraviolet combined AI-driven analysis with advanced 3D printing. They ran flow simulations, asked for recommended wall thicknesses, and iterated geometry based on performance targets. The result wasn't magic. It was faster, cleaner decision-making with fewer reworks.
Close the loop across engineering, finance, and ops
Once materials are selected and geometry is locked, the AI can draft a bill of materials, hand it to finance, and produce early cost rollups. Packaging, vendor options, and forecasting follow quickly. Work that used to take weeks can land in everyone's inbox in a single afternoon.
That tight loop matters. It reduces guesswork, validates feasibility early, and puts product, quality, and finance on the same page before tooling or verification drain the budget.
Making it personal: better oxygen delivery for kids
This isn't abstract for Charlesworth. His daughter has a rare genetic condition and relies on hospital oxygen therapy. Standard nasal cannulas can be loud, uncomfortable, and awkward-especially for children with atypical facial structures.
The team's idea: use AI and 3D printing to create cannulas that fit a child's unique anatomy, improve comfort, and reduce the need for tape. Alongside his work at Ultraviolet, Charlesworth founded The Lovey Foundation to fund research and AI-enabled tools for 14q32 microdeletions, and he serves on the board of the Blow By Oxygen Foundation to support better oxygen delivery for pediatric patients.
A practical 30-day plan to integrate AI in your product workflow
- Week 1: Opportunity scan. Review FDA databases and recent clearances to tag underserved Class I/II devices with repeatable use cases. Score by unmet need, margin potential, and regulatory path.
- Week 2: Build a lean "product intelligence" stack. Centralize PDFs (materials, standards, supplier catalogs, prior DHFs). Add prompt templates for DFM checks, risk analysis cues, and requirements traceability.
- Week 3: Pilot on one SKU. Run flow/FEA summaries, request geometry tweaks, and generate a draft BOM with alternates. Have finance validate cost models and supply risk. Log outputs in your QMS.
- Week 4: Governance and validation. Define AI usage SOPs, verification steps, version control, and PHI handling. Align with ISO 13485 design controls and document human review gates.
- Ship the habit. Add a 15-minute weekly "AI standup" to review wins, misses, and prompts that worked. Keep the loop small and consistent.
Tooling that actually helps
- Data filtering: Summarize materials compatibility, sterilization constraints, and biocompatibility notes into design-friendly checklists.
- Simulation support: Use AI to interpret flow/thermal outputs and flag failure modes for earlier fixes.
- BOM + sourcing: Generate first-pass BOMs with alternates, MOQ notes, and preliminary cost ladders.
- Finance sync: Auto-create costed scenarios and packaging estimates for faster go/no-go decisions.
Learn more at MD&M West
Charlesworth will lead "How AI Is Transforming Medical Device Design & Development, and How to Implement It in Your R&D" on Feb. 3 at 11:15 a.m. in Anaheim, CA. If AI adoption is on your 2026 roadmap, this session will give you concrete steps to move beyond pilots.
MD&M West - event details and registration
If your team needs a fast ramp
Want your product org fluent across AI tools and workflows? Start with focused training your team can apply the same week.
AI is one more instrument in your product toolbox. Use it to cut time-to-proof, find the niches the majors ignore, and build devices that make a real difference.
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