Definitely not “set it and forget it”
The multibillion-dollar US medical device industry is the largest in the world and is tightly regulated — for good reason. Equipment sold in this sector is categorized by its application: life-support equipment, imaging equipment, surgical equipment, electromedical equipment, dental equipment, and endoscopes. Among this family of equipment, life-support equipment is projected to grow the fastest because of the increasing occurrence of acute cardiac and respiratory conditions and increasing traumatic injuries, which tend to occur in older patients — a growing demographic in the United States.
With the advent of IoT and 5G networks and the trend toward real-time health management, the market has been flooded with a wide array of new devices. By nature of their intended use, medical devices are more complex than home or commercial appliances and require regular sophisticated maintenance by highly trained specialists.
A well-known life-support device is the defibrillator, which is used to prevent or correct arrhythmia (uneven heartbeat that is too slow or too fast). A defibrillator sends an electric pulse or shock to the heart to restore a normal heartbeat. To do that, a charge of between 0 and 360 Joules is produced and delivered through paddles or disposable electrodes. If the charge is high or low, it could kill or harm the patient. Clearly, regular inspection and authorized maintenance is required to ensure this device operates within its specified parameters.
Servicing medical devices
Due to their technical nature, high level of intrinsic IP, and mission-critical role, few manufacturers provide service information on medical devices, and it is generally difficult to gain access to technical manuals, read error logs, or run diagnostics tests. Authorized third-party servicers must receive intensive training and accrue extensive experience that cannot be documented in a manual for others to follow.
Some devices require more than 90 customized tools for carrying out service operations. And because many of these instruments require highly calibrated precision, it is of paramount importance that third parties only use original OEM parts in these medical devices.
But recent legislation is changing this picture somewhat. The Critical Medical Infrastructure Right-to-Repair Act of 2020 removes certain intellectual-property-related restrictions on repairing or maintaining critical medical infrastructure; it grants trained biomedical technicians easy access to information and tools required to maintain medical equipment.
This bill also does the following:
- Offers protection to equipment owners, lessees, and servicers from federal copyright laws for producing a copy of service manuals or for breaking a digital lock during the process of repairing a medical device in response to COVID-19.
- Empowers equipment owners or lessees to manufacture patented parts on a non-commercial basis as and when required to maintain or repair medical devices in response to COVID-19.
- Nullifies provisions in medical equipment contracts to the extent they inhibit repair or maintenance of medical equipment in response to COVID-19.
- Requires OEMs to deliver, on impartial terms, access to information and tools required to service, maintain or repair medical equipment.
- Authorizes the Federal Trade Commission to assess the effect of the bill on innovation and competition in the medical equipment industry.
For the medical device servicing industry, Bruviti provides a holistic solution that features its proprietary methodology, optimized by AI. The process begins by ingesting data from a variety of sources such as product manuals, technology forums, FAQs, troubleshooting guides and customer feedback, and more. In the case of medical devices, our service offerings are optimized for the unique nature of this equipment.
- The decision trees generated are very close to the actual observed symptoms on the device. This means a technician is never left wondering what to do next.
- Safety of the technician is paramount because of the hazards posed by certain devices.
- The device and surrounding area are inspected to ensure there are no potentially hazardous spills.
- An initial inspection of the device for damage is recommended.
- A self-test is recommended to check if any error log is generated.
- The correct type of error is identified: user, programming, or settings.
- Errors are eliminated in a systematic and scientific manner, beginning with power, user, followed by input and finally output error, to ensure a thorough check is done in accordance with procedures recommended by the manufacturer.
- Finally, expert advice is recommended in the event of any unknown or new symptoms.
The triage process does not end there. Our no-code studio allows the OEM to seamlessly improve the decision trees based on experience, enabling continuous improvement.
The result is an optimized solution that addresses the needs of medical device OEMs. To learn more about Bruviti’s optimized offerings for the medical device industry, Request a demo.