Guest Columns

  1. 3 Steps For User-Centric Medtech Product Innovation 2/2/2023

    Medtech product innovation balances user desirability, business viability, and technical feasibility. User desirability is often the most difficult to discern. User-centric innovation can be separated into these three clear steps for your best chance at success. The author uses anecdotes from his company developing its recent app.

  2. How To Maximize Your Medtech Booth At Trade Shows: Pre-Show Planning 1/31/2023

    Medical trade shows, congresses, and exhibitions have become primary marketing and business development tools for medtech companies. However, are you putting enough thought/strategy into your pre-show planning to position your booth's team for success?

  3. EU MDR Now Regulates Beauty Devices As Medical Devices 1/27/2023

    The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical devices, including colored contact lenses, cosmetic implants, cosmetic fillers, liposuction, light emitting equipment for skin resurfacing and other purposes, and brain stimulation devices.

  4. 9 Key Investor Milestones Every Med Device Developer Should Know 1/25/2023

    Since few medical device startup companies can bootstrap complete product development, they typically look to investor funding. As daunting and overwhelming as the funding process can be, there are definite guidelines and stages of investor de-risking that can make the design and development process much more on target and successful.

  5. 5 Strategies To Kickstart Your Medical Device Project Teams In 2023 1/20/2023

    After several years of disruption and uncertainty, our medical device teams are ready for a fresh start. These 5 strategies will help your team work on the fundamentals to reach their full potential in 2023.

  6. What's Behind The ASTM E3263 Standard Revision? 1/17/2023

    ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.

  7. 6 Key Inbound Value Chain Considerations For Medical Device Companies 1/13/2023

    Medical device companies were hit especially hard during the pandemic. In 2023, key inbound considerations for medical device value chains will need to include sourcing strategies that enable dependable supply and rapid innovation, sophistication in balancing cost and risk, and agility and transparency in managing uncertainty.

  8. FDA Seeks Comment On Delaying, Denying, Limiting, Refusing Inspections 1/9/2023

    The FDA has released for public comment a proposed draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1. The guidance shares examples of reasonable and unreasonable circumstances. Submit public comments by February 14, 2023.

  9. The FDA & EU IVDR Regulatory Frameworks For IVD SaMD 1/4/2023

    Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746.

  10. Does The FDA Or EU IVDR Consider IVD Software An IVD Medical Device? 12/16/2022

    Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and regulated as Software as a Medical Device (SaMD). In vitro diagnostic devices are known as IVD SaMD. This article summarizes the regulatory requirements in the EU, governed by the In Vitro Diagnostics Regulation (IVDR), and the requirements in the U.S., governed by the FDA.