With lives on the line, medical technology cannot fail!
Safe and Reliable Medical Power Supplies
to bring Next Generation Medical Devices to Life!
Medical Robots for Surgery
Healthcare Services Robots
Holographic Anatomy Surgery Assistance
Intelligent Surgical Tools
3D Medical Printing (Prosthesis and Artificial Organs)
MRI and X-Ray Machines with Instant Detection of Disease Areas
Latest Industry Trends
New Standards for Patient Safety
Created with patient safety in mind, 21 CFR Part 820.5, MDSAP, MDR (21 CFR Part 803) and ISO 13485:2016 are new supplier control initiatives for medical device manufacturers.
The most significant change is inclusion of higher EMC requirements and updated immunity standards for use in areas outside of hospitals and less controlled environments.
The medical industry’s concern regarding hold-up time has increased since the release of the EN 60601-1-2; 2015 (Ed4) immunity standard. Primarily created to address the growing number of products used in home healthcare, this standard specifies multiple AC voltage dips ranging from 20ms to 5 seconds. The longer outages are addressed by batteries or ensuring that no harm will occur to the patient or operator if the power supply output voltage drops out of the regulation band.
BF compliant designs having 1.5kVAC Output - Ground and 4kVAC Input - Output Isolation spacings for withstand voltage, special transformer design and construction, meets Safety defined creepage distances, air clearances, leakage currents.
Reduced length of hospital stays, increased number of outpatient clinics/services leads to increasing popularity of portable, home medical equipment. Since proper grounding can't be guaranteed in uncontrolled locations (outside of hospitals), IEC 60601-1-11 requires that Class II equipment protect non-professional users from electrical shock by approaching all home settings as if they do not have protective earth ground wiring.
ISO 13485
Specifies requirements for a quality management system where an organization demonstrates its ability to consistently meet customer/regulatory requirements (through risk management).
Product/Process Change
Inappropriate or "uncontrolled" changes, which can affect the safety and reliability of products and directly impact public health and safety, has prompted the FDA’s increased scrutiny of medical device manufacturers' supplier controls. The power solution is an essential safety-critical component in many medical devices.
Higher Reliability
High-end equipment in the Medical market is known for long product lifecycles (up to 20+ years). Optimum performance throughout the lifecycle is supported by high quality E-Caps and conservative electrical and thermal derating, allowing reduced field failures.
Patient and operator vicinity environments require quiet or silent power supplies. Convection and conduction cooled units help with this trend.
A power supply is more
than just an electronic device....
It is the heart of our customers' systems
and the core element of safety and reliability.
We are one of the oldest and most trusted manufacturers of high quality medical power supply solutions. According to IHS Market's 2018 AC-DC & DC-DC Merchant Market report, we became the leading power supply manufacturer for the medical device market in 2017.
Our convection-cooled ML series was released in 1979, which featured a modular design for multiple outputs. This enabled medical device engineers to use a single-unit "fanless" solution that provided low acoustic noise.
We are certified and approved to design and manufacture power supplies for medical applications using our own testing facilities to generate UL and CB safety reports and test data. Our medical power supplies are approved for the latest medical safety standards and meet 4th Edition EMC compliance requirements. Multiple ISO 13485 manufacturing facilities demonstrate our ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
A development process requiring products to meet or exceed stringent internal design guidelines. Products are subjected to a series of rigorous reviews with brutally honest and logical judgements at each stage.
Large, global, fully-qualified component database giving economy of scale and long product life cycles
Worldwide unified design standards
Best in class operating life times, field failures are reduced by designing E-caps for 15+ year life, applying proper electrical and thermal derating, and use of high quality components
Higher efficiency and advanced thermal management result in lower operating temps, longer life and lower total cost of ownership
Detailed EVT/DVT test plan incorporating lessons learned from decades of experience in field applications
Uncompromising Product Qualification consistent with IPC9592B guidelines - HALT, TCT, THB, HASS, shock and vibration, demonstrated life testing
Reliability models and component stress analysis; MTBF, Bel-core, Mil-Std-217 and DMTBF analysis in production
Quality can never be assured by final inspection. Quality is an integral part of everything we do. Our process includes a tightly controlled approved vendor list (AVL), incoming inspection, rigorous testing, field proven topologies and components, test data validation, and extraordinary process reliability. These factors combine to generate elite product quality levels.
Industry-leading warranties
Rigid component AVL selection and management process
A supply chain committed to utilize only authorized sources of supply
Advanced statistical controls, Process capability index – Cp, CpK requirements
Pilot production process to study processes and guarantee high manufacturing yields within specification
Many process inspection controls including checkpoints at component, sub-assembly, and final product levels
Professional Failure Analysis to identify root cause to component level
Corrective Action reports (8-D) accompanied by extensive technical support to help resolve application issues and prevent additional failures
Our position as a highly experienced, leading global supplier means we can capitalize on our extensive Advanced Technology Research. Our collaboration with top universities and our expanding portfolio of over 700 patents offers assurances we will provide the next generation of innovative, leading edge power solutions to our customers. Highly motivated R&D teams, located in design facilities worldwide, apply knowledge of the key attributes from a myriad of different applications gained from years of experience.
Leaders in development and practical application of advanced technologies
Higher Efficiencies – leading to less waste heat generation, enabling greater power densities and smaller product sizes
Detailed thermal analysis with derating, allowing peak power requirements commonly found in medical equipment to be delivered reliably and safely without oversizing (and overpaying) for the power supply
TDK-Lambda has benefited from TDK's acknowledged expertise in ferrite and multilayer capacitors by jointly developing advanced components to improve the efficiency and performance of TDK-Lambda's power supply products
Integrating the latest components (GaN semiconductors), topologies (bridgeless totem pole PFC), and design techniques (full digital control)into our latest product designs such as the PFH
In house firmware and software development to develop IP and respond quickly to customer modification requests
Manufacturing is done in TDK-Lambda owned factories. This allows advanced process development and new manufacturing techniques can be seamlessly incorporated into products.
Highly automated DVT and thermal characterization testing process allows testing over a broad range of operating conditions and guarantees consistent results
TDK-Lambda has the unique ability to leverage our global platforms to best utilize the strength of our worldwide engineering teams. This enhances our abilities in quality, reliability, customer support, and innovation for new products.
Six Global Engineering centers of expertise; Japan, China, Singapore, UK, Israel, USA
Attracting & retaining Good Talent - TDK has R&D centers near major universities (Bristol, UK; Tokyo, Japan; Karmiel, Israel)
All TDK-Lambda engineering and sales centers, plus our directly owned factories are ISO9001 and ISO14001 certified
Extensive library of innovative field-proven designs
Comprehensive in-house qualification and validation facilities with FA down to component level
TDK-Lambda has celebrated more than 71 years in the business, demonstrating our longevity in the highly competitive world of power supply design and manufacturing. Since 1945, we have developed a worldwide reputation and heritage for high quality, robust power supplies. As of October 1, 2008, Lambda was fully integrated as part of the Power Systems Business Group of TDK Corporation and became TDK-Lambda Corporation, Inc. Our parent organization, TDK Corporation, is a leading $12+ Billion global electronics company, headquartered in Tokyo, Japan. TDK was established in 1935 to commercialize "ferrite", a key material in electronics and magnetic products.
Diversified Market strategy (Industrial, Medical, Telecom, COTs) has enabled TDK-Lambda to weather the economic market changes
TDK-Lambda sales rank in the top 10 global power supply companies
Uniquely we can provide the optimum manufacturing strategy for your needs in our own fully equipped plants from low volume to high volume manufacturing. We have multiple strategically located warehouses, offering a full menu of logistic services including tailor-made solutions.
Samples, pilots and prototype units from a channel strategy geared around speed & availability
Factories designed and equipped with logistical capabilities capable to scale during growth cycles
TDK-Lambda owned warehouses located in all five (5) key geographic locations
Established set of Distribution partners, carrying more than $25 million in inventory
Program End-of-Life logistic strategies
Power+ Solutions is an extension of value add, where we integrate more of the power assembly around the power supply to offer avenues to increased productivity, lower costs, and offer more flexibility
Our Value Add Solutions & Capabilites is an extension of our standard product platforms, where we integrate more of the assembly and external features around the power supply to offer avenues to increased productivity, lower costs and more flexibility. Our New Jersey manufacturing facility is ITAR certified.
Explore our products and see why TDK-Lambda leads the market in medical power solutions.
