Guest Column Target Topics

We are happy to welcome guest expert bylines sharing:

  • Best practices
  • Pitfalls to avoid
  • Lessons learned
  • Recommendations for how to overcome/mitigate certain common challenges
  • Regulatory compliance tips, trends, and insights
  • Emerging trends
  • And other actionable intel on the topics you see listed below.

Please remember that our audience consists of professionals at life sciences companies who are developing their own medical devices, medtech (including telehealth and SaMD), or diagnostics. Any articles would need to “speak to” and provide practical information for this audience.

Ideally, authors of these guest expert bylines are employed at:

  • Medical device/medtech companies developing their own products
  • Consultancies (or be independent consultants)
  • Academia
  • Non-profit orgs
  • Industry consortia

We cannot accept content from companies that are vendors, suppliers, or outsource partners to our medical device/medtech readers. Content from those types of companies would need to go through our paid media program.

Word count and other details can be found on our Guest Expert Article Submission Guidelines page.

Current Target Topics

Disruptive Technologies’ Impact on Med Device Research and Development

  1. Robotic Surgery
  2. Miniaturization
  3. Materials (e.g., polymers)
  4. Internet of Things (IoT)
  5. Wearables
  6. AI/Machine Learning
  7. Ingestibles
  8. Digital Health, Software as a Medical Device (SaMD)
  9. Manufacturing Techniques and Capabilities
    1. Additive Manufacturing
    2. Rapid Prototyping
    3. Automation
    4. Design for Manufacturing
    5. Robotics

Value Chain Considerations

  1. Inbound Supply Chain Considerations
    1. Contingency Management
    2. Onshoring
    3. Design and Development
    4. Tooling
    5. Components Selection and Manufacturing
    6. Assembly
    7. Partner Selection Criteria
  2. Outbound Supply Chain Considerations
    1. Inventory Management
    2. Packaging and Labeling
    3. Sterilization
    4. Logistics
    5. Repair and Maintenance
    6. End of Life

Clinical Applications Driving Growth

  1. Drug Delivery and Fluid Management
    1. Human Factors For Drug Delivery Device Design
    2. Implantable Drug Delivery (using polymeric, silicone, or bioabsorbable / bioresorbable materials)
    3. Connected Drug Delivery
    4. Quality by Design For Combination Products
    5. High-Volume/High-Viscosity Biologic Drug Delivery
    6. Capital Equipment and Reuseable Devices
      1. Infusion Pumps
      2. Blood Management Machines
      3. Inhalers
      4. Self-Injectors/Auto-Injectors/Wearable Injectors/Transdermal/Micro Needles
    7. Disposables
      1. Syringes and Self-Injectors
      2. Inhalers
      3. Disposable Infusion Sets
      4. Ophthalmic Delivery Devices
  2. Diagnostics
    1. In Vitro Diagnostics (IVDs)
    2. Patient Monitoring
    3. Point of Care (POC) Diagnostics
  3. Orthopedics
  4. Cardiovascular
  5. General Surgery
  6. Respiratory
  7. Biologic/Device Convergence (e.g., Orthobiologics)
  8. Wound Care
  9. Consumables
  10. Neurology

Understanding and Navigating Med Device Regulations

  1. European Medical Device Regulations (EU MDR)
  2. FDA
    1. Establishment Registration & Medical Device Listing – 21 CFR Part 807
    2. Premarket Notification 510(k) – 21 CFR Part 807 Subpart E, Class II
    3. Premarket Approval (PMA) – 21 CFR Part 814, Class III
    4. Investigational Device Exemption (IDE) for clinical studies – 21CFR Part 812
    5. Quality System (QS) regulation 21 CFR Part 820
    6. Labeling requirements – 21 CFR Part 801
    7. Medical Device Reporting (MDR) – 21 CFR Part 803
  3. ISO Standards (ISO 13485, ISO 14971, ISO 9001, etc.)
  4. Harmonization / International Medical Device Regulators Forum (IMDRF)
  5. Unique Device Identification (UDI)
  6. Other Global Regulations (e.g., from U.K.’s MHRA, China’s NMPA, Japan’s PMDA, Australia’s TGA, etc.)

Maintaining Quality Across the Entire Product Lifecycle

  1. Materials Selection Prototype to 10,000th Manufactured Item
  2. Design Through Delivery
  3. Quality Management System (QMS)
  4. Quality Management Plan
  5. Quality Assurance (21 CFR 820, ISO 13485)
  6. Risk Management (ISO 14971)
  7. Human Factors/Useability
    1. Patient Level
    2. Healthcare Provider Level
  8. Sustainability

Commercial Strategy

  1. Market Access
  2. Pricing-Call for Cost Savings
  3. Formulary/Insurance Reimbursements
  4. Political Factors
  5. Selling to and Partnering with Integrated Delivery Networks
  6. Physician Marketing/Training
  7. Academic Medical Centers
  8. Demonstrate Value to Health Care Systems
  9. Improved Outcomes
  10. Patient Adherence and Persistence
  11. Direct to Consumer Strategy