Saylan Consulting

Providing customers high quality design and development engineering solutions.

About Saylan.

Saylan Lukas, MS-BME, MBA

Saylan has 18 years of medical device design and development experience. From startup companies to large international corporations, he has led project teams from initial feasibility through global commercialization in areas of patient specific craniomaxillofacial implants and instruments, transcatheter heart-valve stent grafts and delivery systems, cranial stabilization systems, cancer treatment devices, and laparoscopic instruments.

Saylan has extensive experience in new technology development, computer aided design, 3D printing and prototype fabrication, design verification and validation testing, human factors and usability, risk analysis, manufacturing scale-up, sustaining engineering, and root cause analysis. He has developed and launched multiple products, obtained successful FDA approval on several 510(k) applications, has been awarded multiple patents, and published several technical papers in peer-reviewed journals.

Saylan earned his undergraduate and graduate degrees in Mechanical and Biomedical Engineering from Rose-Hulman Institute of Technology (Terre Haute, IN) and a Master’s in Business Administration from Butler University (Indianapolis, IN).

Services.

    1. Clinical User Needs Discovery and Validation

    2. Market Assessment

    3. Regulatory Strategy

    4. Intellectual Property

    5. Technology Development

  • • Planning & Project Management

    • Risk Analysis

    • Design for Manufacturing

    • Design Verification & Validation

    • Design History File (DHF)

    • Usability & Human Factors

    • Process Validation

    • Supplier Qualifications

  • • QMS Quality Manual, Standard Operating Procedures (SOP), Work Instructions, and Forms

    • Audit Support

    • Supplier Support

  • • Product Development Basics
    • Project planning
    • Risk analysis
    • Human-centered design
    • Design Verification & Validation
    • Statistical analysis

  • Over 18+ Years Industry Experience

    Medical device new product research, design, and development

  • Diverse Background

    Orthopedic Craniofacial Implants; Cardiovascular Transcatheter Heart-Valves and Stent Grafts; Balloon Catheters; Laparoscopic Staplers; Neurosurgical Targeting Systems; 3D Printed Implants; and Wearables and Sensors

  • Patents & Publications

    Seven patents and three publications

Get in touch.

Let’s figure out a time to talk through your design and development engineering needs.

FAQ

  • We start with a comprehensive gap analysis to understand your specific needs, challenges, and goals. This initial conversation allows us to assess your current situation and identify key areas where our expertise can provide value. From there, we'll develop a tailored strategy, outlining the next steps and setting clear objectives to ensure success. Whether you're looking for advice on a specific project or need ongoing support, we'll guide you every step of the way.

  • Our fees are based on the specific services and level of support your business requires. We offer flexible pricing models, including hourly rates, project-based fees, and retainer options for ongoing consulting. After our initial consultation, we'll provide a transparent, customized proposal outlining the costs based on your unique needs. Please contact us for more detailed pricing information tailored to your project.

  • The length of the onboarding process varies depending on the complexity of your business needs and the scope of our engagement. Typically, onboarding takes between 1 to 4 weeks. During this time, we'll dive deep into understanding your organization, align on objectives, gather necessary data, and establish a customized action plan. We'll ensure a smooth transition and set the foundation for a successful collaboration.

  • Yes, we offer fully customized plans to meet the unique needs of your business. Every organization is different, so we tailor our services to align with your goals, challenges, and industry specifics. Whether you need a one-time consultation, project-based support, or a long-term partnership, we will work closely with you to create a strategy that delivers the best results for your business.

  • Absolutely! We have extensive experience working with remote teams and are fully equipped to provide our services virtually. Whether your team is dispersed across different locations or operating remotely, we use the latest collaboration tools and technologies to ensure seamless communication and project management. Our remote consulting approach allows us to deliver the same high-quality support, regardless of where your team is based.