Our patented reconfigurable mixed signal ASIC technology delivers significant benefits for device manufacturers tackling the unique demands of the medical industry.
Medical Device Market Challenges
Medical devices are often portable, battery powered and even implantable. Such device requirements place strong demands on product teams to reduce the Size, Weight and Power (SWaP) of medical devices. Consider these challenges common to the medical devices product space:
Many medical devices must achieve ASIC levels of integration before the project can even enter trials. A large printed circuit board (PCB) full of discrete parts can be used for bench level testing of early prototypes. Unfortunately, attaching such a large device to animals or humans is unreasonable for even the smallest of studies.
The Problem with Early Integration in a Traditional ASIC Flow
While early ASIC integration solves the SWaP requirements in a project, device makers have been reluctant to go that route too soon in the development cycle due to the extreme cost and time delays associated with making changes to traditional ASICs.
Triad’s Reconfigurable ASICs Enable Early Integration and Rapid Prototyping and Innovation in Silicon
Triad’s reconfigurable ASICs enable single mask layer modifications to change any of the analog or digital functions within the ASIC. These single mask layer changes can be made in weeks versus the six month delay often incurred with the full custom approach. Only a single mask layer needs to be refabricated to make changes with no full custom layout required meaning that changes are a fraction of the cost of traditional approaches.
With a Triad reconfigurable ASIC, when a design change is needed due to clinical trial results, new ASICs can be available within as little as six weeks. This rapid response approach is allowing medical device manufacturers to quickly iterate on a design and get to a device worthy of FDA approval a year faster than competitive solutions.
Large medical imaging systems such as CT, PET and MRI scanners utilize ASIC integration to achieve higher resolution systems. High resolution scanners require more acquisition channels to be placed in the same physical area. When these scanners are physically large devices the area where multi-channel electronics can reside is quite constrained. The mixed signal circuitry for a single channel of a PET scanner can be quite elaborate. Attempting to place 32, 64 or more such channels into a constrained physical space requires ASIC integration.
Triad has significant experience with developing multi-channel signal chains that achieve excellent per channel performance while minimizing cross channel interference.
An MRI system involves processing pulse waveforms in the 60MHz to 130MHz range. These signals must be bandpass filtered and digitized with high-speed, high-resolution analog to digital converters (ADCs).
MRI Analog Front-End Electronic Needs
- Low power operation per acquisition channel
- The ability to filter multiple frequency bands
- Sharp, higher order filters in front of the ADC for noise rejection
- Support for non-ferromagnetic packaging
Triad’s Sampled IF ADC (SIF-ADC) technology combines a field programmable intermediate frequency (IF) filter with a high speed, high resolution ADC that can serve as an ideal MRI AFE. The Sampled IF (SIF) filter effectively looks like a FIR filter but implemented in the analog/RF domain. SIF filters can be reprogrammed in the field to create very sharp bandpass filters. The SIF-ADC provides 125MSPS analog to digital conversion at 14 bits of resolution.
The SIF-ADC approach lowers overall power requirements, simplifies and improves anti-alias and bandpass filtering and allows for frequency agile filtering.
Reconfigurable ASIC Benefits for Medical Electronics
One year improvement in development time
Meet Size, Weight & Power goals early in development, accelerating entry into trials and FDA approval
Lowest total-cost-of-ownership in the ASIC industry
Quickly and inexpensively make design changes as a result feedback from clinical, animal and human trials
Design revisions in weeks not months
Real IP protection in an ASIC that will not be sold to others or your competition
Medical Industry Focused Quality and Qualification
Across industries served, Triad is a trusted supplier of mission critical ASIC solutions designed and manufactured to exacting quality standards.
- ISO9001:2008 Certified
- QMED Certified Supplier of Medical Electronics
- Wide range of qualification options optimized for the application and market requirements
- Extensive experience working with customers to obtain FDA approval
- Focus on Long-term Production Supply
Example Medical ASIC Applications
- Electrocardiogram – ECG or EKG Heart activity monitor
- Electroencephalogram – EEG Brain activity monitor
- Electromyography – EMG Muscle activity monitor
- Sphygmomanometer – Arterial blood pressure monitor
- Glucose monitor, blood sugar Blood analyzer
- Portable health monitoring
- Neuro stimulator – Implantable
- Transubcutaneous Nerve Stimulator – TENS Unit Muscular stimulator
- Medical telemetry
- Patient monitoring
- Galvanic skin resistance
- Pulse Oximetry
- Hearing aid
- CT Scanner – Computerized Tomography
- PET Scanner – Positron Emission Tomography
- MRI – Magnetic Resonance Imaging
- Medical Device Unique Serial ID
- Hand-held Surgical Devices
- Infusion pump
Is my company already working with Triad?
The fastest way to find out if your company is currently working with Triad is to request the information through our secure contact form:
We use a multi-factor verification method to insure that you are authorized to obtain such information for your company before releasing any information.
Our customers are often quite secretive about their development of an ASIC with Triad. ASIC integration is a competitive advantage for many of our customers. Many medical device companies are quite large so there is the possibility that we are working with another group within your company without it even being publicized inside your organization. We may very well already be on your company’s approved vendor list (AVL). Using the information request form above is a fast and secure way to learn who within your company is having success with Triad solutions and technology.
FDA Medical Device Classification
Medical devices are classified by the federal drug administration (FDA) into Class I medical devices, Class II medical devices, and Class III medical devices. A medical device is designed to for diagnosis, therapy or surgery with the goal of improving the patient’s health. Medical devices in the United States are classified into one these three classes. The US FDA places devices into these three classes to indicate the amount of risk involved with the medical device and to indicate the procedures that must be adhered to during the manufacture and use such devices.
FDA Class I Medical Devices
A class 1 medical device is a straightforward design and product that has little or no potential risk to the patient’s health. Still, class I medical devices must follow FDA policies with regards to registration of the device, proper branding and approved FDA labeling. Also, the FDA must still be notified prior to marketing such a device. Class 1 medical devices include simple bandages, exam gloves and tongue depressors.
FDA Class II Medical Devices
A class 2 medical device is a more complicated design and product that poses minimal risk to the patient’s health. Class II medical devices must follow the FDA’s general policies and require special labeling, attain mandatory performance standards, and products are subject to post market surveillance. Most medical devices fall into the class II category. Such devices include powered wheelchairs, infusion pumps, surgical needles and diagnostic imaging machines.
FDA Class III Medical Devices
A class 3 medical device is a sophisticated design and must adhere to the strictest quality guidelines because it poses the greatest risk to patient health. In addition to satisfying all of the requirements of a Class I or II device a Class 3 product must undergo a rigorous pre-market scientific review and FDA approval process. Class III devices are used to support or sustain human life making product malfunctions unacceptable. Products such as neuro stimulators, implanted defibrillators, and implanted pacemakers are examples of life sustaining class III devices.
ASIC Solutions for FDA Class I, II, & III Medical Devices
Triad specializes in the development and manufacture of mission critical ASIC solutions for medical device markets.