Guest Columns

  1. Medical Device Packaging Labels 101 3/16/2022

    Medical device labels play an important role in a device’s life. They are key to market introduction and success, a company’s long-term financial viability, and to patients’ health and lives. This article provides advice for getting the label right the first time to avoid product recalls and for the best chance of product success.

  2. Surgical Simulation Training: Trends For 2022 & Beyond 3/14/2022

    Teams developing computer-based medical simulation are now programming with a unique fidelity, effectively mapping surgical procedures. In addition to determining whether a simulated surgery is being performed correctly, simulators can also assess the surgeon's accuracy, efficiency, and speed, and can be used to support patient-reported outcomes.

  3. Your Road Map To Improving Medical Device Sales In 2022 3/11/2022

    The majority of medtech companies have outdates sales practices. This article shares the newest best practices, including the 5 key behaviors and skills of the successful medtech sales rep in 2022, and best practices for your marketing and sales teams to communicate better.

  4. Challenges & Opportunities For Medtech To Assist Rural Americans 3/9/2022

    Rural Americans face significant health disparities compared to their urban counterparts. They also live farther away from healthcare facilities, so transportation is a challenge. This article delves into the various challenges for rural Americans and how medtech developers — and, in particular, developers of remote patient monitoring devices — can help rural patients.

  5. FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations 3/8/2022

    Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including ingestible and implantable sensors, wearables, electronic signatures on consent forms, and more. This article summarizes the key takeaways of the FDA's new draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The public comment period ends March 22, 2022.

  6. The Market Outlook For Robotic-Assisted Surgery In 2022 3/7/2022

    Lack of clinical evidence and commercial barriers have historically limited the adoption of robotic-assisted surgery, despite significant expected benefits to both surgeons and patients. Now, novel technology, new market players, and disruptive business models look to drive expansion in a market expected to reach more than $20 billion in 2030.

  7. What Does EN ISO 14971:2019’s New Amendment Mean For Harmonisation? 3/4/2022

    CEN, the European standards body, recently released an amendment to the European edition of the medical device risk management standard, EN ISO 14971:2019, amendment A11:2021. This article examines the amendment and discusses what this means with regard to harmonisation with the MDR and IVDR regulations in Europe.

  8. 4 Key Strategies When Designing Surgical Robotics 3/2/2022

    Surgical robotics are relatively new. Many clinicians are still discovering the optimal surgical techniques for different procedures and, simultaneously, manufacturers are learning what clinicians really need. The author of this article has many years of experience in developing innovative robotic systems, and he shares 4 key strategies for device manufacturers.

  9. The Clinical Trial Sponsor’s Roadmap To Avoid EMA (Cyber) Perdition 3/1/2022

    Clinical trials are one of the sectors most vulnerable to cyberattacks. In the European Medicines Agency (EMA)'s Guideline on computerized systems and electronic data in clinical trials set to come into effect in 2022, the EMA goes beyond the traditional software validation and data integrity expectations. It sets requirements and expectations pertaining to user management and ongoing security measures.

  10. What’s The Role Of Intuition When Making QRM Decisions? 2/28/2022

    In Part 1 of this 2-part series, this author explained how to effectively set up your quality risk management (QRM) program for pharma and medical devices. In this article, he explains how to implement that program. For such a numbers-based field, there is still an important role for using your intuition to make QRM decisions.