Our Work
Our approach involves working closely with clients by collaborating directly with their leadership and development teams. This allows us to provide technical guidance and produce design deliverables that align with the quality and regulatory framework required to achieve the organization's objectives.
Digital Healthcare & SaMD
Large pharma companies are broadening their approach to healthcare by combining drugs with a drug delivery system (ex: pen injector, patch, infusion pumps), monitoring patient adherence to treatment with a mobile app (ex: diabetes monitoring apps) or creating standalone Digital Health Applications which can replace the use of the drug altogether (ex: Noom).
“As technology continues to advance all facets of health care, software has become an important part of all products, integrated widely into digital platforms that serve both medical and non-medical purposes.”
- FDA
Connecting the doctor, the patient, the prescription/drug and patient adherence to prescribed treatment creates a new eco-system for drug treatment and patient outcome. Personalized virtual care for better health has inspired an uprising of digital healthcare apps, with innovative, multi-condition, whole person healthcare applications creating effortless pathways between the patient, their device data and the patient’s careteam.
Products we worked on.
Infusion Delivery
Drug Device Combination products
Digital Therapeautics
Software as a Medical Device (SaMD)
Mobile Medical Applications
Diabetes Apps
Multi-Disease Software Platforms
Problems we solved.
Project Support: Early & Late Phase Product Development
Mobile App Commercialization
Requirement Writing for Complex Decision Models
Translating Requirements & Specs into Test Cases
V&V Test Strategy Development
V&V Protocols & Report Writing
Established ISO 13485 QMS process & procedures
Safety Assurance Case Development
Technical Direction for Emerging Products Launch
Audit Readiness & Support
Digital Therapeutics Project Planning
SaMD Design & Development
3rd Party Vendor Qualification
Software Tool Qualification & CSV
ISO 13485, ISO 14971, CFR 820.30 GMP & Compliance Training
Notified Body Audit Readiness & Support
Surgical Robotics
Surgical robots have emerged as a revolutionary technology in healthcare, offering numerous benefits over traditional surgical techniques. One of the primary benefits of surgical robots is their ability to perform minimally invasive procedures, which can lead to less pain, scarring, and faster recovery times for patients. This can also result in shorter hospital stays and reduced healthcare costs.
In addition to improved patient outcomes, surgical robots also offer increased precision and accuracy during surgery. They can provide a better view of the surgical site and allow surgeons to perform complex procedures with greater control, minimizing the risk of complications or errors. However, the use of surgical robots is not without challenges. There are concerns around the cost of the technology, the need for specialized training for surgeons and support staff, and potential ethical issues around the use of robots in medicine.
Overall, the benefits of surgical robots in healthcare far outweigh the challenges and the future of healthcare is likely to be shaped by this revolutionary technology, and its integration into clinical practice could lead to improved patient outcomes and more efficient healthcare delivery.
Products we worked on.
Class III Surgical Assisting Robot
Endoscpic Knee Robot
Problems we solved.
System Architecture Design
Design Integration & Vallidation
Concept Initiation & Development Planning
Design Planning & Requirement Writing
Software Design Documentation
Automated Testing Set Up & Validation
Clinical Training Simulation Design
Risk Management Planning & FMEA Analysis
510k Regulatory Submission Preparation
AI/ML Algorithms / CADe Systems
Effectively, CADe devices are computerized systems intended to identify, mark or highlight portion(s) of a radiology image, that may reveal specific abnormalities during clinician interpretation of patient radiology.
CADe devices utilize AI/ML models to combine information which are used to rate or categorize regions within an image with respect to disease, condition, or abnormality. This model is an assumed relationship between image features and the rating or categorization of disease /abnormality, and depends on a specific set of parameters that are determined either manually or automatically. AI models and classifiers typically perform some type of pattern recognition procedure.
Use of CADe devices include identifying colonic polyps on CT colonography studies, prompt filling defects on thoracic CT examination, detecting liver lesions and identifying lung nodules on CT, x-ray, or MRI.
Products we worked on.
Intelligent Endoscopy Module
Artificial Intelligence System for Colonoscopy
Problems we solved.
Algorithm Design and Function
Algorithm Processing & Features
Algorithm Training & Datasets
Clinical Performance Assessment
Standalone Performance Assessment
Model Detail Design Artifacts
Human Factors Validation
Ground Truth Software Validation
510k Regulatory Submission Package
Endoscopes & Arthroscopic Instruments
Endoscopy procedures have become an essential tool in modern healthcare, providing numerous benefits over traditional surgical techniques. Often categorized as Class II products, these surgical devices are continually evolving to meet the needs of our Healthcare professionals while enabling faster patient recovery times.
Today, endoscopy has become an essential tool in modern healthcare, with a wide range of applications in diagnosing and treating medical conditions and are now available in a variety of sizes and shapes, allowing doctors to examine different parts of the body, including the gastrointestinal tract, lungs, bladder, and joints.
Technological advances have led to the development of specialized endoscopes, such as the capsule endoscope, which can be swallowed by the patient and used to examine the small intestine. Robotic endoscopy systems have also been developed, which allow for greater precision and accuracy during procedures. As technology continues to advance, we can expect to see even more widespread adoption of endoscopic procedures in clinical practice. This could lead to improved patient outcomes, reduced healthcare costs, and more efficient healthcare delivery.
Products we worked on.
Surgical Camera Heads
Endoscopes & Arthroscopes
Surgical Blades and Tissue Removal Devices
Gynecological Surgical Devices
Problems we solved.
DHF Remediation
Established ISO 13485 & EU MDR QMS Procedures
Audit Findings & CAPA Support
ISO 13485, ISO 14971, CFR 820.30 GMP & Compliance Training
Tech File Generation
Software Validation
Infusion Delivery Systems
Primarily intended to deliver essential fluids/medications to patients, infusion systems must be designed not only to be safe but also user friendly. Smart pumps are being developed that use advanced algorithms to monitor and adjust infusion rates in real-time, reducing the risk of medication errors and improving patient safety. These pumps can also wirelessly transmit data to healthcare providers, allowing for more effective management of patient care.
Implantable devices are also being developed for long-term drug delivery, allowing patients to receive medication without the need for repeated injections or infusions. These devices are programmed to release medication at specific intervals, ensuring that patients receive a consistent dosage over an extended period of time.
A recent development is the use of Nanotechnology; which is being explored as a potential solution for more precise and targeted drug delivery. Nanoparticles can be engineered to target specific cells or tissues in the body, reducing the risk of side effects and improving the effectiveness of medication.
Products we worked on.
In-home dialysis systems
In-center dialysis systems
Fluid Management monitors
Apheresis system
Problems we solved.
QMS Remediation - Improved Integration of Risk Management
DHF Remediation
Implementation of Security Risk Management Processes
New Product Development Challenges (e.g late stage resolution of conflicting requirements)
Safety System Design
Process Validation (including Test Method Validation, IQ, OQ, PQ, etc).
Cardiac Devices
The future of cardiac devices is an area of rapid development and innovation, with a focus on improving patient outcomes, reducing complications, and enhancing quality of life for individuals with heart conditions. Among the emerging technologies in this area, key innovations range from Wearable and Remote Monitoring Devices to Artificial intelligence and machine learning.
Wearable and remote monitoring devices are becoming increasingly popular, providing patients with continuous monitoring of their heart function, blood pressure, and other vital signs. These devices transmit data to healthcare providers in real-time, allowing for early intervention and proactive management of heart conditions.
Still, tissue engineering and regeneration techniques are being developed to repair and regenerate damaged heart tissue. Stem cells, gene therapy, and other innovative approaches are being explored as potential treatments for heart disease, with the goal of eventually replacing the need for traditional cardiac devices.
A wildcard yet significant technology, could be the use of artificial intelligence and machine learning to develop predictive models for heart disease and improve personalized treatment plans. These technologies can analyze large amounts of data and identify patterns and risk factors, allowing for early intervention and more effective management of heart conditions.
Products we worked on.
Implantable Heart Devices
Heart Pumps
Problems we solved.
New Product Development
Design Input Requirements Writing
Risk Management Planning & FMEA
V&V: Strategy & Planning
V&V Testing & Documentation
SaMD Design & Development
Software Validation
Early Feasibility Studies
Notified Body Audit Readiness & Support
Imaging, Scanning & Surgical Navigation
A significant amount of this growth can be attributed to an increase in the prevalence of chronic diseases, paired with an ageing population, creating greater demand for these imaging procedures. The market is also still being impacted by the recovery from the Covid-19 pandemic, as imaging needs were not met during the pandemic and the market is still attempting to catch up to the backlog of demand.
As a result of the pressures on this market, companies are attempting to produce more advanced technologies and more accessible procedures to address the growing demand for imaging. This has placed more emphasis on developing products centered on point-of-care diagnostics such as hand-held or portable ultrasound devices, which saw a huge boom in usage during the Covid-19 pandemic.
It’s not uncommon for large organizations to struggle with how to appropriately address and implement these new regulations into their existing processes, leaving structural and compliance gaps that only expand as time goes on.
Products we worked on.
MRI Machines
Imaging Scanners
Surgical Navigational Devices
Problems we solved.
Product Development
V&V Strategy Planning
V&V Test Protocol Writing & Execution
Notified Body Audit Readiness & Support
Imaging System Product Development
Manufacturing Planning
Process Validation
Tool Validation
Test Method Validation
Contact us.
Let us help you navigate the expanding field of Medical Device design & development.