Developing an implantable medical device is one of the hardest things in MedTech. You’re building something that has to work in the body, communicate through tissue, deliver precise therapy, and do it all reliably, safely, and efficiently — often with a team and budget that’s a fraction of the size of class I or class II devices with broader patient populations.
We’ve seen teams pull it off brilliantly, and we’ve seen great ideas stall because of small missteps — technical and not — early on. A poor performing subsystem, focusing on the wrong milestone, and misunderstanding timing needs can all derail new product development and commercialization programs. But the good news is you don’t have to trade speed for safety, or burn capital to buy progress. You just need to spend your time and money on the right risks.
Here’s how the best teams do it.
1. Focus your capital on value-creating milestones
When resources are tight, your capital has to do double duty — reduce technical risk and increase company value. That doesn’t mean moving slower or cutting corners. It means organizing your plan around the next clear value inflection point, the milestone that will make investors, regulators, or partners say, unequivocally, “this works”.
For some teams, that’s proving therapeutic effectiveness in an animal study. For others, it’s showing safe and stable wireless power in vivo, or demonstrating a therapy effect in a small human feasibility trial. Everything you build should trace back to that milestone. If it doesn’t, it’s probably nice-to-have engineering. And nice-to-haves quietly kill startups, especially when they’re not what your stakeholders expect to see.
2. Don’t reinvent what’s already solved
Implantables are complex, multidisciplinary systems — mechanical, electrical, firmware, materials, and bioengineering all intersect. Every subsystem adds cost and delay.
And the data is clear: the biggest source of technical failure in implantables isn’t always therapy efficacy, but power delivery, wireless telemetry, and long-term reliability. Studies in MDPI Electronics (Ghaed et al., 2013), IEEE Transactions on Biomedical Circuits and Systems (Rhew et al., 2019), and other publications show that failures in power management and data communication are some of the primary cause of NPI delays and post-commercialization recalls across multiple device classes.
So if someone has already solved those challenges — especially in power, energy, and telemetry — buy, license, or partner. Preserve your engineering time and capital for what truly differentiates your therapy. Because every month you’re not troubleshooting your system design or power link budget is a month closer to your next de-risking milestone.
3. Build for adaptation, not perfection
No first-generation implantable device survives its own learning curve. Designs evolve after testing, power requirements change with therapy tuning, and regulatory input shifts what’s acceptable.
The teams that adapt fastest are the ones who build modularly — with clear boundaries between therapy delivery, user experience, power, and communications. Modular architecture lets you swap out one subsystem without throwing away the others. It’s not just good engineering practice; it’s a hedge against the unknown, protecting both your time and your runway.
4. Treat regulatory engagement as capital protection
Too often, teams wait until their design is “ready” before talking to regulators. Instead, early engagement — even an informal pre-submission or Q-sub — can give you valuable feedback on your device classification, predicate path, and testing expectations before you commit to expensive verification. Then, you can feel more confident when you’re ready to file a formal submission such as a 510(k), de novo, or PMA.
If a single conversation or submission can save months of redesign later, that’s not paperwork — that’s capital preservation.
5. Make your data part of the product
Data is the one asset that appreciates over time. Every test you run, every failure you analyze, every preclinical or pilot result you collect — they all tell the story of your device’s reliability and performance. That story is what convinces investors, regulators, and partners that your technology works and can scale.
Build good data habits early. Structure your experiments. Capture context. Keep your raw data accessible. Use partners as data sources. Over time, your data becomes not just a record of progress, but a competitive advantage.
6. Time is your most expensive cost
You’ll rarely see “delay” as a line item in a budget spreadsheet, but it’s usually the biggest expense. Every month you’re delayed adds another month of burn — salaries, overhead, and opportunity cost — while competitors move ahead.
Preserving capital means managing your critical path with the same rigor as your budget. Identify the tasks that gate progress — long-lead components, regulatory dependencies, verification testing — and manage them actively. When possible, outsource testing and compliance efforts to enable internal focus and parallel path different development, risk mitigation, and pre-commercialization needs.
Delays compound. So does discipline. Planning for the unknowns and leveraging partners who’ll tackle the unknowns with the same dedication as your internal team can mean the difference between meeting timelines and losing credibility with investors.
7. Build credibility before you build scale
One of the fastest ways to increase company value without increasing spend is validation — from the right partners, clinicians, or strategic investors. A well-run preclinical study with a respected investigator can do more for your valuation than a polished prototype. A technical collaboration with a strategic partner can unlock both capital and credibility.
Don’t wait to engage. Look for proven paths to show you know what you’re doing. Because credibility compounds, just like data.
8. Power and data: the invisible risk that derails timelines
One thing we’ve seen time and time again: power and data bottlenecks sink as many or more implantable programs than therapy efficacy. If unaddressed and unsolved, power systems drain time, talent, and capital. They determine device size, reliability, and usability, and they’re the hardest to change late. Addressing them early doesn’t just de-risk your device technically; it protects your schedule and your valuation.
But building internally is hard. Developing an implantable medical device is already complex before power is factored in — safety, efficacy, clinical validation, and regulatory compliance all compete for focus. Beyond competing for resources, power system development can cost millions of dollars and years of runway that could have been spent proving your therapy, rather than reinventing power. This comes from hiring specialized electromagnetics and power electronics engineers, undergoing multiple design integrations, performing costly and time-consuming EMI, EMC, and thermal testing, and revisiting power needs as your implant form factor evolves.
A better approach is to validate your wireless link, continuous power or recharge approach, and data path under realistic tissue conditions, all before design lock. You’ll save months — even years — and avoid costly redesigns.
9. Raise capital around de-risking events, not time
Every fundraising round should tie directly to a specific de-risking milestone. “We need 18 months of runway” isn’t a compelling story. “This round gets us through preclinical testing and key compliance milestones like EMI to position us for a first-in-human next year” or “This round gets us to first-in-human data, proving device efficacy and reliability” is.
An event-driven approach minimizes dilution, aligns your team and investors, and builds confidence in your capital discipline.
Final thought
Preserving capital and reducing risk in implantable development isn’t about moving cautiously. It’s about moving intelligently. You can’t eliminate uncertainty, but you can decide which uncertainties to pay down first — especially those on which stakeholders are focused. Buying what’s already solved, designing for flexibility, engaging regulators early, and treating data as a core asset all combine to help you derisk your path to market while preserving capital.
These decisions don’t just stretch your budget — they increase your company’s value with every milestone. And at Resonant Link Medical, we see it all the time: the teams that succeed aren’t the ones that spend the most or have all of the answers. They’re the ones who spend the smartest, who recruit the best team for what they need — regardless of whether they’re in house — and who get answers to their most important questions early.
If you want to derisk your device’s path to market while building business value, reach out.
