KritiKal Solutions Inc. is a premier technology services firm with a global footprint and over 22 years of experience. It excels in product engineering, R&D, and cutting-edge innovation and has catered to its clients through over 500 projects with its deep expertise across AI-driven vision systems, embedded technologies, and cloud and mobile software solutions.

Contacts

sales@kritikalsolutions.com

India Phone Number

(0120) 692 6600

USA Phone Number

+1 (913) 286 1006

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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.

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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
  1. Remote Patient Monitoring System
  2. Personal Emergency Response System
  3. Patient Support Apparatus
  4. Wearables & Self-Diagnostic Tools
  5. Smart Neck Band for Cattle & Pets
  6. Telemedicine Devices
  7. Connected Medtech Kits, Apps & IoT Devices
Radiological Imaging & Diagnostic Tools
  1. Embryo Grading Platform
  2. Lungs X-Ray COVID & Pneumonia
  3. Mammogram Tool for Breast Cancer
  4. AI Fetal Ultrasound Analyzer & A-Fib
  5. Fundus Imaging for DR/Glaucoma
  6. AI Low Dose Imaging CT/MRI
  7. AI Skin & Hair Analysis
Therapeutic & Specialized Systems
  1. Electrotherapeutic Waveform Devices
  2. AI Polyp Analysis for Colonoscopy
  3. 3D Guidance for Assisted Orthopedic Procedure
  4. Surgical Instrument Detection



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Our Expertise in Medical Device Product Development

Self-Diagnostic Device design
Self-Diagnostic Device

An early diagnostic multi-sensor tool that continuously monitors ECG, physical activities, blood pressure, glucose, and reports on proactive health insights. The BPL-quantified device measures key vitals irrespective of time or place and can be used for self-monitoring against diabetes and cardiovascular conditions. This medical device design is AI-powered, user-friendly, and seamlessly integrates with a clinical user interface and hardware.

Epilepsy & Pulse Watch Design
Epilepsy & Pulse Watch

Our advanced wearable device is supported with epilepsy tracking mobile applications. The wearer can call for assistance at the onset of fit to reduce the chances of injury before the occurrence of an actual attack. We also developed an industrial design for a smartwatch that delivers medical-grade blood pressure stats without interfering with the patient’s lifestyle.

Advanced Vision Analyzer design
Advanced Vision Analyzer

A lightweight headset for glaucoma and diabetic retinopathy testing across remote clinics that can be powered using mobile phones. The intuitive device has built-in eye power compensation, a modular architecture, and is blacked out, thus eliminating the need for dark rooms. The medical product design features accessibility to precise testing and ergonomic viability as it can be used by semi-skilled resources in patient homes in the absence of dark rooms.

Breast Examination Device
Breast Examination Device

We developed a patented non-invasive solution that precisely detects cancerous mass within the breast using tactile sensing technology. The comfortable and small device utilizes objective data to generate an electronic map during clinical examination. It can be easily operated by physicians to assess surrounding tissue and suspicious masses and perform informed decision-making as compared to conventional manual methods.

Infant Monitoring Patch design
Infant Monitoring Patch

Our medical device design company developed an infant monitoring ultra-thin smart patch built with medical-grade material that monitors sleep position, temperature, and breathing. It features 15-day battery life, USB charging, adjustable positioning as a diaper clip-on, fabric, or band-aid. The affordable device has extremely precise sensing technology and accompanies a smartphone app for real-time alerts.

Myelin Patch design
Myelin Patch

A wearable embedded gadget with fabric-enclosure combination that measures neurological data across the patient’s body in a cost-effective manner. The medical device development involved cohesive integration of the tool over a technical fabric for users to wear discretely while consistently checking various body points in the background through AI-based predictive algorithms.

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.

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// Compliances

We Comply with Highest Quality Standards

We follow all necessary compliance standards across our integrated medical device design and development process. Our dedicated team of experts showcase high quality assurance acumen and evolve development practices according to recommended regulations. We develop products structured by certified and well-audited pipelines which fastens their approval and time to market, not only assuring high-quality services, but also guaranteed customer satisfaction.

We operate in alignment with ISO 13485:2016, ISO 27001:2022, and other regulatory standards and best practices as mentioned.

We Comply with Highest Quality Standards associated with medical design and development

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

01
Medtech Solutions
Discover our wide range of medical devices, skin and hair analysis solutions, embryo grading platforms, wearable therapeutic and diagnostic devices, etc.


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02
Industrial & Product Design Services
We deliver transforming industrial Medtech product design services such as seamless managed production, product innovation and engineering, digital service designing

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03
Electronics Manufacturing Services
Our comprehensive offerings include prototyping, PCB manufacturing, quality assurance, and mass production services, supply chain management, high-performing factories, etc.
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Our Success Stories

Electrotherapeutic Medical Device for Pain, Insomnia & Depression

EMS/MedTech/

Pet and Cattle Health Monitoring & Tracking Device

EMS/MedTech/

AI-based Cancer Screening Solution thumbnail
AI-based Cancer Screening Solution

AI/MedTech/Vision/

AI-based Remote Patient Monitoring Thumbnail
AI-based Remote Patient Monitoring

AI/Cloud IoT/MedTech/

AI-based Cuffless Diagnostic Device Thumbnail
AI-based Cuffless Diagnostic Device

AI/Cloud IoT/MedTech/

Why Choose Us?

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. 

All-in-One Medical Device Product Development image

FAQs

What is medical device design?

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. 

What does a medical device design company do?

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. 

What is the medical device development process?

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 

Do you need to develop a prototype for medical device design and development?

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. 

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