Global 
United States 
Medical Device Design and Development
We provide end-to-end services, right from conceptualization, medical device product development, product design, dedicated prototyping, contract engineering, manufacturing, and testing.
Combining diverse expertise to deliver impactful healthcare outcomes for over 23+ years
Our strength is rooted in our deep, diverse pool of expertise and seasoned professionals with industry-agnostic acumen. Together, the team contributes distinct skills and unique perspectives to tackle real-life challenges and consistently deliver exceptional results
As a medical device design company in dallas, KritiKal has expertise in the development of the same for various small, medium, large businesses, and original equipment manufacturers. Do you have a concept or design you wish to bring to life? We can be your one-stop shop for prototyping, testing, producing, and refining your vision starting from any given phase of your product’s evolution. Our modular services offer flexible and extensive project management. Let us establish common objectives and work in sync to achieve them using our high-value full product lifecycle development services.
- Conceptualization, Medical Design Validation & Verification
- Industrial Medical Device & Human Factors Engineering
- Quality Planning & DHF Management
- Testing, Regulatory Approvals & Manufacturing Transfer
- Post-Market Support and Rapid Troubleshooting
Our Medtech Capabilities
Connected Health Monitoring
- Remote Patient Monitoring System
- Personal Emergency Response System
- Patient Support Apparatus
- Wearables & Self-Diagnostic Tools
- Smart Neck Band for Cattle & Pets
- Telemedicine Devices
- Connected Medtech Kits, Apps & IoT Devices
Radiological Imaging & Diagnostic Tools
- Embryo Grading Platform
- Lungs X-Ray COVID & Pneumonia
- Mammogram Tool for Breast Cancer
- AI Fetal Ultrasound Analyzer & A-Fib
- Fundus Imaging for DR/Glaucoma
- AI Low Dose Imaging CT/MRI
- AI Skin & Hair Analysis
Therapeutic & Specialized Systems
- Electrotherapeutic Waveform Devices
- AI Polyp Analysis for Colonoscopy
- 3D Guidance for Assisted Orthopedic Procedure
- Surgical Instrument Detection
Let's create something together
Our Expertise in Medical Device Product Development
Self-Diagnostic Device
Epilepsy & Pulse Watch
Advanced Vision Analyzer
Breast Examination Device
Infant Monitoring Patch
Myelin Patch
Let’s Discuss Your Project
Take the next leap in product development. Partner with KritiKal to integrate your ideas into the real world. Let ‘s get on a quick call for 30 min.
Our Medtech Cybersecurity Services
Healthcare and medical networks face the highest breach costs that can average up to $10.22 million per incident*. A cyber event or attack occurring within the clinical environment or medical technology solutions can directly impact safety alarms, therapy delivery, as well as life-critical actuation. One needs to ensure that medical devices stay under control, safe, and functional, even when faced with a cyberattack.
Our control assurance approach includes:
- Fail-Operational Safe Mode
The device continues in a clinically safe operational state after isolating from the network during anomalies without shutting down fully. - Clinical Command Validation
Incoming commands are validated against physiological safety limits, such as dosage boundaries, and authorization levels in real-time by firmware logic. - Dual-Channel Trust Architecture
This architecture separates the Safety Controller (motor/therapy) and Connectivity Processor (Wi-Fi/BLE) to prevent compromised connectivity stacks from driving actuators.
(*As per 2025 IBM Report)
Protected Health Information (PHI) across mobile ecosystems and public networks is transmitted by connected care and remote monitoring systems. This makes them extremely vulnerable to unauthorized configuration changes, spoofing, and even impersonation. KritiKal helps MedTech teams align with key frameworks and regulations that include:
- USA: FD&C Act, HIPAA, FCC, NIST CSF 2.0
- EU: MDR, IVDR, GDPR, CRA, ETSI EN 303 645, NIS2
- India: CERT-In Directions, DPDP Act, MTCTE, BIS IS 18004, BIS IS 17428
Zero-Trust measures we implement:
- Hardware-Anchored Identity (Root of Trust)
Keys are protected inside an HSM/secure element to sign device telemetry and device identity. - Encrypted Telemetry Pipelines (mTLS)
PHI can be protected against Man-in-the-Middle (MitM) attacks on public networks through mutual authentication and encryption. - Secure BLE Bonding & App Authentication
Unauthroized mobile control can be prevented through application-level encryption (including OOB pairing) and strong pairing.
KritiKal enables embedded cybersecurity for Medical IT solutions and devices where attacks can lead to unsafe operations, false alarms, therapy disruption, and patient harm. We assist manufacturers in meeting product lifecycle requirements like FDA 524B and EU MDR, including patching and post-market monitoring.
Our MedTech cybersecurity portfolio covers:
- Secure-by-Design Protection
Dual-Channel Trust Architecture blocks actuator control via a compromised communication stack while a secure boot verifies kernel/firmware integrity prior to execution to prevent persistent malware/rootkits. - Resilient Updates & Downtime Protection
Safe recovery and near-zero downtime can be ensured through verified updates via Atomic FOTA with rollback support. Compliance can be preserved by blocking unauthorized downgrades using a cryptographic version in monotonicity through rollback prevention. - Vulnerability Monitoring & Threat Engineering
Faster remediation and proactive alerts through continuous SBOM-based vigilance against vulnerabilities. STRIDE threat modeling, risk assessment, and prioritization based on affected users, damage, exploitability, reproducibility, and discoverability. - Legacy System Protection
Trafic sanitization before it reaches vulnerable components like old interfaces, dongles, ang gateways using Virtual Patching and Wrapper security controls.
Medical Device Design & Development Phases
Phase 0:
Requirement Gathering
Initialization of user research as per business requirements and product features.
Phase I:
Concept Development
Our experts conduct in-depth research on market requirements and infuse contemporary 3D modeling designs that harmonize problem resolution.
Phase II:
Engineering
For medical product development, we establish advanced engineering specifications as per project plan developed with formal design controls for manufacturability.
Phase III:
Validation
We offer systematic verification after narrowing down the best testing methods as per DOE studies to ensure that performance meets defined design input criteria.
Phase IV:
Manufacturing Transfer
We assist you in scaling up by testing products by validating product or process capabilities and sterility.
Explore our other Expertise
Medtech Solutions
Industrial & Product Design Services
Electronics Manufacturing Services
What Our Clients Say
Vishwaprasad Alva
Managing Director, Skanray TechnologiesOur Success Stories
All-in-One Medical Device Product Development
Comprehensive Experience: Backed by an extensive chain of suppliers, medical device design engineers, and domain experts, we have assisted several OEMs in strategizing, designing, engineering, and commercializing a wide range of Class I, II, and III medical devices.
Lowered Expenses: With a first-hand understanding of industrial product requirements in Dallas, latest tech, equipment and software usability, our design engineers reduce complexities and manufacturing costs.
Reinforce IP Portfolio: End-to-end medical product development enabled with competitive analysis, compliance tracking, tech evaluation, design control, offshore component sourcing, subassemblies, and distribution.
Minimized Risks: You can accelerate time-to market with our global network of suppliers, ISO and QSR compliance, and accommodate changes rapidly at competitive costs for a timely product launch.
User-centered Approach: We prioritize usability and safety in all phases, ensuring regulatory excellence, and seamless transitions from design to production, while eliminating unnecessary do-loop costs for businesses across Dallas.
Regulatory Readiness: Our products are aligned with FDA and EU MDR requirements and are ISO 13485 certified. We are committed to guiding customers in the USA through the purpose-driven product lifecycle and beyond.
FAQs
Medical device design refers to outlining safe, effective, and user-friendly tools via research, prototyping, and testing. This process assures seamless device production, regulatory compliance, usability, ergonomics, and comfort of the patient.
A medical device design company assists businesses in the HealthTech domain to visualize, conceptualize, design, prototype, and engineer their product or offering ideas. They help them navigate regulations and deliver safe, effective, user-friendly Medtech technologies for enhancing patient care across the globe.
KritiKal has conducted medical device development for various organizations and enhanced the features to optimize usability and adherence to regulatory standards. We applied human-centered designs for Medtech SMBs, Fortune 500 companies, and startups, and systematically tested them for market readiness
Yes, rapid prototyping and adept research is required to test human factors, embed innovation, reduce risks in medical device design and development, and validate usability. We offer extensive prototyping by gaining and executing feedback through real-world scenarios, necessary iterations, and in-depth user insights prior to market launch.
