ICS Establishes Dedicated Medical Device Practice

Integrated Computer Solutions Inc. (ICS) is establishing a dedicated medical device practice in direct response to increasing demand for complex medical devices.  The company’s work in the medical and life sciences markets has increased 93 percent year-over-year due to the rising demand.
 
“We partnered with ICS for the software development of our CellFX System, our first commercial product which has received 510(k) clearance by the FDA and CE mark approval both earlier this year. The CellFX System leverages our patented Nano-Pulse Stimulation technology to offer dermatologic solutions that until now have remained unfulfilled,” said Darrin Uecker, president and CEO of Pulse Biosciences (Hayward, Calif.). “As with all medical devices, design considerations are paramount to ensure functionality, safety and usability. That’s where ICS’ expertise was essential in helping us build an intuitive software-enabled, cloud-engaged device that offers discerning aesthetic skin specialists exceptional and seamless ease of use.”

As connected technologies drive innovation and transform healthcare, medtech companies look to ICS’ user experience (UX) and software engineering teams to help deliver improved patient experiences and outcomes and gain strategic advantages. Expectations are that the global Internet of Medical Things (loMT) will have a valuation of $158 billion in 2022, up from $41 billion in 2017. 
 
Building on its history as a leader in UX design and software development for embedded devices, ICS has continuously invested in its medical technology practice, adding talent with critical competencies to leverage and adapt technology advances, and service offerings in human factors engineering, cybersecurity, AI and robotics, cloud services and regulatory compliance. Today’s complex devices require greater focus on usability aspects from both UX design and regulatory perspectives. ICS’ team of UX and visual designers and software engineers use ISO-13485 and IEC-62366 compliant processes in full-stack product development leading to 510(k) submission. 

“There has been extraordinary innovation and growth in the medtech sector in recent years which has only accelerated due to COVID-19,” said Peter Winston, CEO of ICS. “ICS has deep experience in UX-driven device creation which is well-suited for the safety-critical requirements of modern medical devices. While developing these devices has become far more complex, it has also raised the bar and opened new possibilities for groundbreaking devices. This has led to expanded opportunity and the establishment of our dedicated medical device practice.”

ICS’ Areas of Medtech Investment: 

• Expansion of cybersecurity team competencies for development of robust programs designed to mitigate inherent risk at a time when cybersecurity vulnerabilities for connected medical devices are a continuous threat to patient safety.
• Increased resources for regulatory compliance including PreMarket Notification (Class II, 510(k)), PreMarket Approval (Class III) and Support for ISO 14971 hazard analysis and dFMEA. 
• Enhancement of cloud service capabilities including expertise in cloud native development, architecture and engineering leveraging services from AWS, Azure and GCP as cloud connectivity reshapes the healthcare industry, affording fast and secure collection, analysis and transmission of healthcare-related data. 
• Significant expansion of UX and human factors teams to assist customers with translating user behavior to product requirements. As modern medical devices have increasingly diverse user groups and multifaceted UX requirements, ICS’ goal is to enhance usability and identify risks early during the development process, supporting increased user satisfaction and improved time-to-market, so the final product can become the market leader.
• Continued development and integration of several innovative technologies that enable rapid prototyping and facilitate rapid-turns in medical device design, delivering a more mature first- generation product.

 
ICS’ dedicated medtech practice offers end-to-end product design and development for medical device and life sciences companies such as Thermo Fisher Scientific, Quidel, Boston Scientific Corp., and MilliporeSigma, helping them build vital devices including drug-delivery pumps, defibrillators, cancer-killing proton radiation systems, and intelligent respiratory and ventilation devices. 

ICS creates sophisticated embedded and touchscreen-enabled devices.