Learn new product development in the healthcare industry from our experience. Follow the article's steps to discover the best approach for these projects.

It would be indiscreet to argue against the relevance of technologies in medicine. Just recalling the significant reduction in mortality from cardiovascular diseases over the last 50 years due to medical advancements suffices as evidence. Diagnostic and therapeutic procedures have evolved not only through the progress in medical science and healthcare practices but also through the devices employed in the field. For instance, robotic surgical systems enable surgeons to perform operations with greater precision and reduced risk of complications.

Read on to discover more about how EnCata contributes to the improvement of modern medicine through healthcare systems engineering.

Our Experience in Developing Devices for Diagnostic and Therapeutic Procedures

Engineering Solutions for Minimally Invasive and Precise Surgical Interventions

Robotic surgical systems enhance accuracy and control during operations, enabling surgeons to perform complex procedures remotely and leverage the unique expertise of specialists worldwide. Training systems for surgeons, based on virtual reality technology, are also becoming increasingly prevalent. An example of such a system is the MedVR project, which we worked on several years ago.

MedVR is a laparoscopy apparatus designed for training in conducting operations, practicing surgeons' instrument skills, and simulating collective actions during operations using virtual reality technology.

The laparoscopy apparatus MedVR

During the development of MedVR, we faced a challenge. The surgeon-client we collaborated with was not the end-user of the system and couldn't provide precise technical requirements. In such a situation, we proposed creating a simple device prototype for digitizing indicators, testing it on surgeons, and asking for their feedback.

The project was extensive, so we divided it into 5 stages. In the first stage, we designed the industrial design of the software-hardware complex for surgical operation modeling. Next, we developed a single dissector node that had to perceive the actions of the trainee for data transmission to the software part and provide feedback. The dissector closely resembled the real one in construction and perception and had the same functionality. Then, we prepared a mathematical model for calculating the 3D coordinates of the virtual instrument based on the values of 4 angular coordinates. Calculations were necessary to position scissors, clamps, needles, and other tools in the software. The next step was the production of the dissector node prototype, its testing, and debugging the software on the manufactured prototype. The results of the dissector node testing helped us select the most suitable algorithms for data processing. After validating the entire device model, we modified the kinematic scheme, reducing the parasitic load on the dissector node, relocating the cutting movement load motor from the dissector body to the handle, reducing the dissector's mass, and increasing the angles at which the close placement of 2 dissectors does not interfere with each other.

Endoscopic Instruments

Endoscopy involves the use of specialized instruments, often equipped with a camera, for visualizing and examining internal organs such as the gastrointestinal tract, respiratory, and urinary systems. These devices enable medical professionals to diagnose diseases such as gastrointestinal bleeding, ulcers, tumors, and polyps at earlier stages.

Our team also participated in the development of a magnetic endoscope. A magnetic endoscope is a control system for an endoscopic capsule. The device is operated using a joystick that controls permanent magnets. The magnetic field creates the necessary force to control the position of the capsule in 5 degrees of freedom in space.

Control node for 1 magnet out of 3 in the magnetic endoscope

The illustration above depicts the control node for 1 magnet out of 3 in the magnetic endoscope. A customer approached us with a request to develop a system designed to control the endoscopic capsule during the examination of the gastrointestinal tract, including the stomach, as well as the small and large intestines. The patient swallows a special capsule with a camera. As it moves through the gastrointestinal tract, the camera takes pictures and transmits information to a recording receiver located externally. The doctor analyzes the data and provides conclusions. After some time, the capsule is naturally expelled from the body.

We performed the industrial design of the magnet movement node of the magnetic endoscope and prototyped the first version of the industrial design. As part of the project, our team also conducted a kinematic analysis of 3 variants of the magnet movement node, developed a control system for the movement node, and created a program for controlling the movement node.

Ensuring the required degrees of freedom of movement was one of the challenges we addressed by modifying the mounting plane of the carriage.

We also developed and manufactured a prototype of the control electronics for the magnetic endoscope, designed and produced the control system for the stepper motors of the magnetic endoscope with external encoders, and developed both embedded and external software.

Remote Patient Monitoring

Remote Patient Monitoring (RPM) is used for collecting and transmitting patient data from a distance. Devices transmit health indicators and symptoms from the patient's location to medical professionals in real-time.

Our team developed a hardware and software suite for emergency medical services (EMS).

This system monitors vital signs such as heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2) and triggers an emergency call if the patient's condition deteriorates. The hardware-software complex includes a wearable module, service, and application software. The device processes and analyzes heart rate, heart rhythm, and saturation. If critical indicators are detected, the system automatically calls for emergency assistance using a GSM antenna.

EMS Call System

EnCata designed the industrial design of the medical device (an example of which can be seen above), engineered the electronics, developed the device's software, and produced a batch of prototypes for testing.

The electronic solution for the device included the following components:

  • A board with a SIM 868 modem for internet communication via the mobile network, voice communication, microphone, SIM card, GPS, and GSM antennas for transmitting patient data to medical personnel.
  • A board with a Wi-Fi module and antenna for determining the patient's geolocation.
  • A board with a lithium-polymer battery charge controller.
  • Accelerometer and gyroscope for capturing data on physical activity and the person's position.
  • Sensors for telemonitoring data on the person's health status (e.g., pulse, blood pressure, blood sugar level).

The customer received 10 prototypes of the bracelet for alpha and beta testing. The device's electronics were presented on a 6-layer board. Currently, the hardware-software complex is successfully used for monitoring the health status of patients.

Development of Medical Devices – It's Costly

The development of medical devices is a complex and resource-intensive process that requires significant financial investment. According to Frost & Sullivan, the average cost of developing a new medical device ranges from $10 to $200 million. Here are a few specific examples illustrating the difference in costs between the development of medical and consumer devices:

  • Developing a new insulin pump can cost between $50 to $100 million.
  • Developing a new pacemaker can cost between $100 to $200 million.
  • Developing a new smartphone can cost between $1 to $2 million.
  • Developing a new refrigerator can cost between $500 thousand to $1 million.

Several factors contribute to these high costs, and they come as no surprise:

  • High Safety and Efficacy Requirements: Medical devices must be safe for patients and operators and effective in performing their functions. This necessitates thorough risk analysis, the development of fail-safe mechanisms, and extensive testing.
  • Complex Design: Medical devices are often intricate and multifunctional, requiring the use of advanced technologies, which also increases development costs.
  • Stringent Regulatory Requirements: Medical devices must comply with strict regulatory requirements set by governing bodies, resulting in high labor and financial expenses.

The development of medical devices always involves in-depth risk analysis, fail-safe mechanisms, and thorough testing. For example, a hearing aid failure on a busy street could lead to tragic consequences, as the individual might not hear an approaching vehicle, tram, or emergency vehicle. Medical devices running on batteries require efficient energy management. In such cases, engineers must consider energy-efficient components or use renewable energy sources to extend battery life. For instance, choosing ZigBee for device communication is more optimal than WiFi because ZigBee is 25% more energy-efficient. Therefore, a ZigBee-based blood pressure monitor will operate for 12 months, while a WiFi-based one will last only 9.

In a device released by Johnson & Johnson, a defect was discovered in the insulin delivery system. The defect involved the needle, which in some cases, could fail to fully penetrate the skin, leading to incorrect insulin distribution. As a result, patients could receive too little or too much insulin, leading to serious consequences, including hypoglycemia or hyperglycemia.

Johnson & Johnson conducted an investigation and found that the defect was due to a design error. The company admitted that it had not paid sufficient attention to safety issues during the device's development. The recall of the device cost Johnson & Johnson billions of dollars.

The company compensated patients affected by the defect and had to undergo an expensive device recall.

This case serves as a vivid example of how attempting to cut costs in the development of a medical device can lead to severe consequences. Johnson & Johnson had to pay a high price for their oversight.

In Closing,

New product development in healthcare is a complex and costly process. At every stage of the medical device development cycle, from research and prototyping to clinical trials and product registration, adherence to regulatory requirements and compliance with standards are crucial to creating a safe and functional product while minimizing the risks of failure.

The healthcare device market is highly competitive, emphasizing the importance of careful risk analysis and preparation. For instance, the recall of Johnson & Johnson's Insulog 2.0 device cost the company billions of dollars, underscoring the point that cutting corners in the early stages of development can lead to significant financial losses in the future.