EXPERTiS Tecnología

BACKGROUND

I am the Head of product and engineering of Hera Biotech, LLC

Hera Biotech develops HeraFem™, a handheld point-of-care device that combines multispectral optical reflectance and electrical impedance spectroscopy with an on-device explainable AI classifier to screen for cervical precancer in a single, real-time exam, with no lab processing required.

OPPORTUNITY / CHALLENGE

• We required an engineering partner capable of evolving the product across multiple generations as our understanding of the technology matured.
• We wanted to bring a novel screening solution to market without building an internal embedded engineering team, keeping our focus on the clinical side.
• We needed to develop a medical screening device from scratch, starting from a clinical hypothesis with no existing hardware or firmware implementation.

SOLUTION

Referral

• Pricing fit our budget
• Good value for cost
• Company values aligned

2-5 Employees

EXPERTiS Tecnología served as our embedded electronics and firmware partner for HeraFem™, a handheld point-of-care device for cervical cancer screening that combines multispectral optical reflectance and electrical impedance spectroscopy. The engagement spanned multiple product generations, from early proof-of-concept prototypes through the current device configuration used in clinical studies and our regulatory submission. EXPERTiS worked alongside our internal R&D, quality, and manufacturing teams, adapting the design as clinical findings and manufacturing requirements evolved. Key deliverables included: Electronics design: Schematic capture, PCB layout, and design iterations for the main device board and biosensor interface, integrating multispectral optical sensing, LED illumination control, and impedance measurement circuitry. Embedded firmware: Acquisition firmware for synchronized optical and electrical measurements, sensor gain control, and multi-point data capture per exam. Sensor data pipeline: Structured outputs at several processing levels (raw counts, gain-adjusted values, and relative reflectance) to support device-to-device standardization and clinical data analysis. Device web interface: An embedded web server for device operation and data retrieval, customized with Hera Biotech branding. Manufacturing support: Definition of PCB inspection criteria and production-ready board revisions, enabling in-house assembly and process validation under our quality management system. Technical documentation and support: Design documentation and ongoing engineering support for design changes, troubleshooting, and integration with our design history file.

RESULTS & FEEDBACK

The device is currently used by physicians in clinical studies across several locations in Mexico, collecting real-world data to refine our detection algorithms.

The product achieved a reasonable and over expected accuracy in early validation, confirming the core detection hypothesis that enabled our transition to clinical research deployment.

Working jointly with Hera’s R&D team, EXPERTiS co-developed three major product generations over 13 years, from proof of concept through a commercially authorized device now active in clinical settings. Measurable outcomes include: Regulatory approvals: Both the predecessor device (2018) and the current HeraFem™ generation (August 2026), obtained COFEPRIS marketing authorization in México. Clinical deployment: Jointly developed devices supported a multi-center clinical study across several sites in México with more than 2000 enrolled patients, and a fleet of clinical units is now deployed for an ongoing validation study. Data acquisition at scale: Firmware developed with captures hundreds of synchronized optical and electrical measurements per exam in a single point-of-care session, producing the datasets used to train and validate our screening classifier. Manufacturing transfer: Production-ready electronics and PCB inspection criteria, defined jointly by both teams, enabled Hera to assemble devices in-house and enter formal process validation under our quality system. Commercial readiness: The authorized design supports our commercial launch through distribution partners in México.

• Timeliness: Deliverables were consistently met on key program milestones, including the builds supporting our multi-center clinical study and our COFEPRIS submissions. When scope changed because of clinical or manufacturing findings, EXPERTiS re-planned transparently and communicated the impact on schedule early.
• Responsiveness: The team responded quickly to urgent technical needs, such as firmware adjustments, data output changes, and troubleshooting on clinical units, often turning around fixes within days.
• Adaptability: As a medical device developer, we work under formal design control and change management. EXPERTiS adapted their workflow to our quality system, supporting documented design changes, inspection criteria, and traceable revisions.
• Communication: Direct access to their senior engineers made technical discussions efficient. Decisions were made jointly, and their team was candid about technical risks and trade-offs.

• In-Person Meeting
• Virtual Meeting

What sets EXPERTiS apart is their ability to act as a true development partner over the long term. Few engineering firms stay with a medical device program for 13 years and three product generations, and that continuity preserved technical knowledge that would otherwise have been lost with each redesign. 

• Multidisciplinary depth: Our device combines multispectral optical sensing and electrical impedance measurement in a compact handheld form factor. EXPERTiS handled both domains in the electronics and firmware, working jointly with our team on signal integrity, acquisition timing, and data quality, which is a rare combination in a single partner.
• Understanding of regulated development: They recognize that medical device engineering is about more than functional hardware. It also requires traceability, controlled design changes, and evidence that holds up under regulatory review. That mindset contributed to two COFEPRIS authorizations on generations we developed together. Clinically driven iteration: When clinical or manufacturing findings required changes, EXPERTiS engaged with the underlying problem rather than just executing a specification, and proposed solutions alongside our engineers.
• World-class capability in México: EXPERTiS shows that deep-tech medical electronics can be co-developed in México to international standards, with the added advantages of proximity, time-zone alignment, and close collaboration with our Monterrey manufacturing site.

Our experience with EXPERTiS has been very positive, and the following suggestions reflect the natural evolution of a long partnership rather than significant shortcomings.

• Formalized medical-device documentation: As our program matured into a regulated product, much of the design documentation had to be adapted on our side to fit our design history file. Adopting medical-device software lifecycle practices from the start (e.g., structured requirements, traceability, and verification records aligned with IEC 62304) would make EXPERTiS even stronger for medtech clients.

BACKGROUND

Please describe your company and position.

I am the President of St. Clair Electrical

Describe what your company does in a single sentence.

Manufacture electrcalmechanical contorls

OPPORTUNITY / CHALLENGE

What specific goals or objectives did you hire EXPERTiS Tecnología to accomplish?

• We needed an embedded engineering partner to develop electronic control products for the automotive aftermarket, without the overhead of building an internal engineering department.
• We required a team capable of working directly with our clients' engineering teams, taking ownership of hardware design and firmware development end to end.
• As our business grew, we needed a partner who could support increasingly complex projects, including reverse engineering, manufacturing test systems, and regulatory requirements.

SOLUTION

How did you find EXPERTiS Tecnología?

Other

Why did you select EXPERTiS Tecnología over others?

• High ratings
• Pricing fit our budget
• Good value for cost

How many teammates from EXPERTiS Tecnología were assigned to this project?

2-5 Employees

Describe the scope of work in detail. Please include a summary of key deliverables.

Reverse engineering of 5 different SMT circuit boards.

RESULTS & FEEDBACK

What were the measurable outcomes from the project that demonstrate progress or success?

More than 40 electronic products were delivered across the automotive and industrial sectors over a 24-year collaboration, supporting clients such as Ford, Chrysler, and Caterpillar.

Embedded engineering capabilities were integrated into the client's core service portfolio, enabling the pursuit of projects and clients that previously fell outside their scope.

Describe their project management. Did they deliver items on time? How did they respond to your needs?

The team is very responcive.  Great comunication.  Expertis went above and beyond our expectations.

The project was completed within the quoted lead time.

What was your primary form of communication with EXPERTiS Tecnología?

• Virtual Meeting
• Email or Messaging App

What did you find most impressive or unique about this company?

They have connections with major electronic component manufactures which give them tha capability to recomend the proper component for a spicific project.

They also check for upcoming obsolesence of components which saves from design modifications.

Are there any areas for improvement or something EXPERTiS Tecnología could have done differently?

None at all.