How ACHB Developed an Innovative High-Voltage Medical Device System Prototype for a Medical Device Manufacturer

A leading medical device manufacturer specializing in developing high-performing systems for the healthcare industry collaborates with leading healthcare providers to develop innovative medical instrumentation and systems, and med-tech solutions for its clients. The company manufactures high-quality balloon catheters used to provide non-invasive patient care. To increase the effectiveness of its catheters and explore innovative concepts for ablation, the manufacturer explored the development of a high-voltage medical device system that would execute ablation through electroporation techniques. To achieve this, the manufacturer needed to:

1. Explore diverse configurations for developing the high-voltage medical device system.
2. Develop a prototype of the innovative high-voltage medical device system – which is a relatively new solution for ablation procedures.
3. Determine the critical electrical components, hardware, software, and their configuration to develop a functional prototype.

The Problem?

The exploration of different configurations and the development of a functional prototype required some extensive design and manufacturing research to reduce the risks associated with using the innovative high-voltage medical device system. The company also needed to ensure that prospective configurations met the required regulations attached to using a Class III device within the healthcare industry and to reduce production costs.

Lastly, as a Class III device, the high-voltage medical device system utilized current or electrical energy to execute operations within the human body. If excess energy is used, this would harm the patient and defeat the purpose of the innovative medical device’s operation. Hence, the client needed to ensure the selected configuration delivered the optimal energy that guaranteed patient safety.

To execute comprehensive research and to develop a functional prototype, an engineering team with extensive knowledge of electrical engineering, engineering fabrication, and the application of medical technology was required. The company realized that it needed technical assistance from experienced electrical and electronics engineers, well-versed in medical device manufacturing, to develop its innovative high-voltage medical device system.

The company expected the expert engineering team to provide further guidance on the choice of materials and design configurations that could:

1. Reduce production cost.
2. Shorten the production cycle.
3. Optimize mass production and commercialization plans.

ACHB's engineer is reviewing the design drawings.

Coordinate measuring machines(CMMs) from ZEISS.

Partnering with ACHB to Achieve Cutting-Edge Innovation

Realizing its technical limitations, the company searched for a team of experienced contract manufacturers with knowledge of the medical device industry. Their search focused on enterprises with extensive experience in:

1. Safely configuring electronic components that utilize high voltages to work within the high-voltage medical device system.
2. Understanding the diverse medical applications intended for the high-voltage medical device system.
3. Manufacturing high-tech medical devices to support patient care.

Using the above criteria as a yardstick, the client reached out to ACHB outlining the conceptual ideas for the high-voltage medical device system and asked how it could be made a reality. Realizing the critical importance of this project and its unique understanding of medical device manufacturing, ACHB’s engineering team set up a series of interviews to gain more insight into the project.

The interviews provided ACHB with the opportunity to ask the critical questions needed to understand the challenges the company faced and how they intended to utilize the high-voltage medical device system. These comprehensive interviews gave the engineering team considerable insight into the intended use cases of the high-voltage medical device system from the perspective of the healthcare provider and the patient. Combined with extensive market research, these insights enabled ACHB to develop a high-performing plan that convinced the client to outsource the prototyping process to ACHB.

Prototyping the High-Voltage Medical Device System

With the specifications for the system in place, ACHB’s software and hardware development team went to work. ACHB employed the use of its fabrication equipment and made use of advanced software development kits and microprocessors to develop a functional proof of concept (POC) for the high-voltage medical device system.

During the prototyping stage for the POC, a high-level approach was utilized. This ensured that the configuration of the developed item was as close as possible to that required for the end product to function optimally. The team produced the high-voltage medical device system using its in-house fabrication equipment and development kit to protect the client’s intellectual property throughout the production cycle.

The production process included multiple designs and contextual testing of the different configurations and components the client highlighted during the interview stage. The POC was successfully developed within six months. It showcased the optimal software and hardware configuration required to develop and safely use the high-voltage medical device system when providing patient care.

Prototyping the Future with ACHB

Medical devices are expected to continue improving the level of care patients can expect to receive in the future. The projected increase in the medical device market size over the next five years highlights an accelerated adoption rate and the opportunities available to medical device manufacturers. Taking advantage of this significant market starts with getting production right and meeting the diverse governmental regulations associated with each device.

The experienced engineers at ACHB assisted the client with developing a functional POC of the high-voltage medical device system, which forms the basis for commercial production and their go-to-market plans. The success of the innovative high-voltage medical device system showcases ACHB’s collaborative approach to manufacturing medical devices for the healthcare industry. Learn more about developing your innovative medical device prototype by speaking with an ACHB expert today.