How custom lithium battery solutions power innovation in medical devices

An in‑depth guide for MedTech OEMs, engineers, compliance leaders, and hospital tech teams.

Why power in medical devices is a life‑critical design choice

Medical devices, from handheld monitors to implantable systems, must run reliably, predictably, and safely. A momentary power hiccup can disrupt diagnostics, therapy, or even patient safety. Traditional off‑the‑shelf batteries may be cheaper or easier to source, but they often force compromises in size, runtime, thermal behavior, or regulatory readiness.

Custom lithium battery solutions let device makers design power systems that match exact electrical load profiles, mechanical constraints, safety margins, and certification pathways, rather than forcing device design to fit a generic battery. The result is devices that are safer, more compact, longer‑lasting, and easier to validate for regulated markets.

Market context, why now is the moment for custom medical batteries

Recent market analyses underscore strong growth in lithium batteries for medical use.

• Meticulous Research reports the global medical lithium battery market was valued at USD 1.72 billion in 2024. It is expected to reach USD 1.84 billion in 2025 and grow to about USD 3.45 billion by 2035, at a CAGR of 6.5 percent from 2025 to 2035. North America leads in share. Asia‑Pacific is the fastest‑growing region.
  
  
• WiseGuy Reports projects the global lithium battery for medical devices market was USD 4.58 billion in 2024 and is expected to grow to USD 10.8 billion by 2035, at a CAGR of about 8.1 percent from 2025 to 2035. North America is expected to lead, Europe follows closely, and Asia‑Pacific shows the highest growth rate.

Why this matter? Demand is not only rising, it is diversifying across device types and regions. That makes the case for tailored battery design even stronger. Custom solutions help manufacturers stand out and meet specific clinical, mechanical, and regulatory needs in fast‑growing application areas.

Use‑case spotlight, how energy needs vary by medical device category

Different medical devices have very different power, size, and safety requirements. These categories illustrate why one‑size‑fits‑all batteries often fail.

1. Wearables and home monitoring

Examples include portable ECG or pulse oximeters, continuous glucose monitors, and consumer‑grade devices with clinical relevance.

Needs. Ultra‑compact form factor, long runtime or multi‑day use between charges, stable voltage for sensitive sensors, and safe operation in near‑body or home environments.

Custom benefit. Thin, flexible or prismatic packs shaped to the enclosure. Battery chemistries tuned for safety and shelf life. BMS tuned for low‑current loads, low self‑discharge, and predictive alerts.

2. Diagnostic and imaging equipment

Examples include portable ultrasound, handheld scanners, and point‑of‑care diagnostic units.

Needs. Higher peak currents for displays, processing, or probes. Frequent charge cycles. Compact but robust housings. Sometimes operation in various climates or outside hospitals.

Custom benefit. Packs designed for peak load delivery, thermal balance, and rapid charge in tight spaces. Controlled cell pairing and BMS tuned to high‑current pulses.

3. Therapeutic and life‑support devices

Examples include infusion pumps, ventilators, surgical tools, and transport monitors.

Needs. Extreme reliability under continuous or mission‑critical use. Sometimes swappable packs in hospital settings. Strict safety and documentation.

Custom benefit. Modular, swappable units with redundancy. Detailed testing, traceability, and safeguards built into pack and BMS for regulatory readiness. Form factors that fit sterilizable or rugged enclosures.

4. Implantable and ultra‑low‑drain applications

Examples include pacemakers, neurostimulators, and long‑life implantable sensors.

Needs. Multi‑year life with minimal maintenance. Ultra‑low self‑discharge. Biocompatibility concerns. Very small size.

Custom benefit. Specialized chemistry choices, custom cell formats, and extreme focus on thermal stability, safety margins, and long‑term reliability.

Taken together, these categories show that medical devices are not a uniform market. Custom packs give designers control over the exact tradeoffs they must balance, such as energy density versus cycle life versus safety versus form factor.

Chemistry and cell technology, choosing the right building blocks

Selecting the right cell chemistry and format is one of the most fundamental decisions in a custom battery design.

Common lithium options and where they shine

1) NMC or cobalt‑rich blends
Strength. Higher energy density for space‑constrained devices, useful for portable diagnostic equipment or high‑capacity wearables.
Tradeoffs. Generally shorter cycle life than some safer alternatives. Thermal management and BMS must be carefully tuned for safety.

2) LFP, LiFePO₄
Strength. Excellent cycle life, thermal and chemical stability, and better tolerance to abusive conditions. A strong choice for devices with continuous or frequent use, such as transport monitors or home therapy units.
Tradeoffs. Lower nominal voltage and slightly lower energy density than NMC. Needs more careful pack design if space is extremely tight.

3) Specialized or emerging chemistries
Ultra‑low drain, long‑shelf‑life needs in implants or sensors can motivate specialized chemistries or cell formats. Emerging technologies such as solid‑state batteries offer improved safety and potential for thinner designs, helpful for wearables or new implant concepts. Growth drivers in the overall market anticipate such innovations, underscoring opportunities for forward‑looking designs.

Form factor matters

Prismatic cells are excellent when you need compact, flat shapes for enclosure integration. Cylindrical cells can offer strong mechanical robustness and often good energy density for portable devices. Coin or button cells matter for ultra‑low‑drain and very small devices. Custom modules or flexible cells can also be designed for specific housings, especially in new wearables or curved surfaces.

A strategic selection often uses a mix of chemistry and form factor to hit electrical, mechanical, and safety targets simultaneously. That is the heart of custom design versus picking an off‑the‑shelf pack.

Design and integration challenges unique to medical devices

Medical devices raise practical design issues that go beyond typical consumer electronics or industrial gear.

1. Sterilization, cleaning, and durability

Devices used in hospitals or clinics may require frequent cleaning, exposure to chemicals, or even sterilization. Battery housings and seals must withstand this without compromising safety or performance. Custom packs can specify enclosure materials, sealing, and IP ratings matched to expected cleaning protocols.

2. Thermal stability and heat management

Even with thermally stable chemistries, heat generation during discharge or charging must be managed. In tight enclosures, poorly managed heat shortens life, triggers safety faults, or degrades devices in hot rooms or vehicles. Custom solutions allow for placement strategies, heat paths, and specific temperature sensing that generic units often lack.

3. Ergonomics and modularity

Handheld or wearable devices place batteries close to users. Ergonomically shaped packs can improve comfort and handling. Swappable modules reduce downtime in hospitals, especially valuable in therapeutic or transport devices. Custom connectors and mechanical latches can be designed for quick swaps without compromising safety or sealing.

4. Connectivity and smart diagnostics

Many modern medical systems benefit from battery telemetry, SOC or SOH reporting, or alerts to maintenance teams. Custom BMS design can integrate SMBus, CAN, UART, or wireless protocols tuned to device software. Smart packs help shift maintenance from scheduled swaps to predictive maintenance based on real usage, saving cost and reducing risk.

Safety, compliance, and the regulatory landscape

Safety and compliance are non‑negotiable in medical devices. Custom battery designs must correspond to variety of standards and transport rules. Two illustrative areas follow.

1. IEC 60601 series for medical electrical equipment

The IEC 60601 family governs basic safety and essential performance of medical electrical equipment. It combines a general standard with collateral and particular standards for different device groups. Evidence of multiple parts exists across various equipment types, showing the breadth of the series that must be considered.

Custom battery packs must be designed to support compliance with the relevant parts of this series, including safe operation, mitigated risk, and appropriate user interaction, depending on device type.

2. Quality management and medical device supply chain

ISO 13485 defines requirements for quality management systems specific to medical device design and manufacture. It emphasizes consistent design controls, risk management, and regulatory compliance. A battery supplier or OEM aligned to ISO 13485 can better support device makers in meeting regulatory demands, documentation, and risk controls.

This becomes especially important when a custom pack must be validated, traced, and documented throughout the device life cycle.

3. Safe transport of lithium batteries

UN 38.3 testing is required for lithium batteries before transport. These tests simulate severe transport conditions, covering environmental, mechanical, and electrical stresses. Manufacturers must demonstrate compliance in the design, manufacturing, and distribution of their products.

Lack of test summaries or documentation can lead carriers to refuse transport, making compliance essential for global distribution.

Implication. Custom battery design must incorporate testing, documentation, and quality controls from the start. Otherwise approval, shipping, and long‑term device reliability become significantly harder.

Service life, reliability, and maintenance, practical benefits of going custom

Custom lithium battery packs can deliver measurable operational benefits.

1. Longer service life and fewer replacements

Tailoring cell chemistry, pack capacity, charge profiles, and BMS logic to the device’s exact usage can increase cycle life and reduce battery turnover in hospitals or clinics. Longer life directly lowers total cost of ownership and reduces waste, meaning fewer interruptions, fewer purchase cycles, and less time spent managing inventory.

2. Predictable performance in real settings

Custom packs can be tested under real device load profiles and environments, not just generic test conditions. This reduces surprises when devices move from lab to field. Thermal and voltage stability combined with real‑time SOC and SOH reporting keeps critical devices running within design limits.

3. Easier service and safer maintenance

Modular or swappable packs designed for medical settings reduce downtime. Staff can change batteries quickly without specialized tools, while still maintaining safety and sealing. Clear diagnostics from BMS warn staff before packs reach unsafe temperatures or low charge thresholds, preventing abrupt device failures mid‑use.

Bottom line. Custom design often yields systems that are not only safer, but also easier and cheaper to maintain in the long run, especially in large fleets of devices or continuous‑use clinical settings.

Sustainability, lifecycle, and end‑of‑life considerations

Hospitals, regulators, and OEMs increasingly focus on reducing environmental impact.

1. Fewer replacements, less waste

Longer cycle life and better stability mean fewer batteries end up in recycling or disposal each year. This is highly relevant for hospitals seeking greener operations or compliance with emerging sustainability policies.

2. Material sourcing and recyclability

Custom packs can be designed with traceable materials and clear end‑of‑life handling instructions. Well‑documented packs help recycling partners process units safely and efficiently, especially if chemistries or modules are known and standardized.

3. Alignment with broader institutional or regulatory goals

As environmental requirements evolve, having custom packs whose design and documentation can be updated or improved helps keep devices compliant without re‑engineering entire systems.

Strategic advantage. Sustainability can be a differentiator, especially in public or academic healthcare systems looking to minimize environmental footprints, while still delivering high performance and safety.

Future outlook and emerging innovations

Medical devices are becoming more mobile, connected, and intelligent. Batteries must keep pace.

1. Smart, connected batteries

Telemetry and IoT integration let facility managers or OEMs monitor health, predict failures, and optimize charging schedules. Packs that report degradation or unusual thermal events in real time enable faster, data‑driven maintenance, reducing costs and improving safety.

2. Miniaturization and flexible designs

Advances in cell formats, solid‑state technologies, or ultra‑thin chemistries can allow wearables and implants to shrink further, or to embed more capacity into the same form factor. As wearable and implant technologies diversify, custom packs will be needed to tune performance, safety, and mechanical fit to new enclosures.

3. Hybrid approaches and energy harvesting

Hybrid power architectures, for example combining small batteries with energy harvesting or wireless charging, could extend runtimes or reduce dependency on large packs. Even in such scenarios, custom design is critical to manage energy flows, match voltage requirements, and ensure safety in novel configurations.

Takeaway. The medical industry’s future devices will push boundaries of size, autonomy, and connectivity. Custom batteries are not just a current advantage, they are nearly a requirement for many emerging applications.

Actionable guide, what every OEM or device team should ask when considering a custom battery solution

Below is a practical checklist you can use or share with partners. It is short, actionable, and suited to technical and procurement teams.

1. Define exact electrical needs
   Peak current, continuous current, voltage range, duty cycle.
   Expected runtime per charge and recharge constraints.
   
   
2. Map out mechanical constraints
   Available volume, shape, mounting points, connector types.
   Sterilization or cleaning requirements. Enclosure IP rating targets.
   
   
3. Safety and regulatory alignment
   Applicable IEC 60601 parts, ISO 13485 quality controls, and transport rules.
   Requirements for traceability, documentation, labeling, and testing.
   
   
4. Thermal and environmental conditions
   Operating temperature range, heat dissipation needs, storage conditions.
   Worst‑case scenarios and how quickly the pack should detect and respond.
   
   
5. Maintenance and serviceability
   Swappable versus permanent packs, module design, connector reliability.
   Diagnostic data needs, such as SOC, SOH, and temperature. Alert thresholds.
   
   
6. Lifecycle and sustainability goals
   Target cycle life, end‑of‑life handling, recycling pathways.
   Source material traceability, documentation, and supplier commitments to compliance.
   
   
7. Integration with device electronics and software
   Communication protocols for BMS.
   Firmware integration, warning messages, charging logic, and updates.
   
   
8. Scale, cost, and time
   Anticipated production volume, cost targets, timeline for prototyping to full production.
   Testing schedules, retesting after design changes, and supplier capacity.
   
   
9. Future expansion
   Possibility of next‑gen cells, new chemistries, or different module sizes.
   Whether design allows subsequent capacity upgrades or form‑factor changes.
   
   
10. Partner expertise
    Experience with medical devices, safety standards, and global shipping.
    Track record of test documentation, quality management, and long‑term support.
    
    

Using this checklist early avoids late‑stage surprises, especially around safety testing, shipping compliance, or unexpected thermal issues.

Final thoughts

Custom lithium battery solutions in MedTech are not just a nice‑to‑have. They are a practical response to real technical, safety, regulatory, and sustainability challenges. As devices get smarter, smaller, and more mission‑critical, the power system must be designed with equal rigor.

If your device roadmap includes new wearables, portable imaging, therapeutic tools, or implantables, a thoughtfully designed custom pack can be the difference between a product that simply works and one that leads the market. Use the guidance above to evaluate partners, shape your design targets, and build batteries that help medical devices deliver better outcomes, safely, reliably, and sustainably.

About Us

With over a decade of experience in battery technology, Dan-Tech Energy specializes in providing cutting-edge, custom lithium battery solutions for the MedTech industry. Our commitment to innovation and excellence has made us a trusted partner for companies worldwide.

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