Guest Columns

  1. The Taiwanese Bone Graft Substitute Market: A Small, But Profitable Target

    With less than 25 million residents, Taiwan flies under the radar of many medical device manufacturers. However, the low penetration rate of bone graft substitutes and a rapidly aging population, make Taiwan a potentially lucrative target for orthopedic biomaterial manufacturers considering expansion in the Asia Pacific region.

  2. 7 Common Mistakes That Sink FDA 510(k) Clearance

    The 510(k) clearance process is often met with a mix of trepidation and anticipation by medical device companies, and medtech companies’ desire to bring products to market quickly can lead to a few common mistakes.

  3. Learn From Past Mistakes: Preparing For MDSAP And International Commercialization

    In today’s complex and constantly changing medical device world, it is more important than ever to fully understand regulations — particularly those regarding communication with Notified Bodies — to be able to comply with quality and regulatory requirements in Europe.

  4. Should Every Device Be Connected? Weighing the Risks and Benefits of Medical Device Connectivity

    Medical device manufacturers that are considering adding or expanding connectivity options should think carefully about what they are trying to achieve, and develop a strategy that balances the risks and rewards.

  5. How to Prepare Your Design History File For An FDA Inspection

    For some medical device companies, an FDA visit can be scary and stress-inducing — if you don’t have your ducks in a row.

  6. New CMS Payment Rates for 2018; Same Challenges for Medtech

    On Aug. 2, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates Medicare payment and polices when patients are discharged from hospitals from Oct. 1, 2017, to Sept. 30, 2018.

  7. Do OR Disposables Have A Future In Value-Based Healthcare?

    Medical device companies are about to get a hard audit from hospitals. Read this critical advice from someone going through it now. 

  8. Supply Chain Risk Where You Least Expect It — Good Supply Practices For The Life Sciences

    The medtech, pharma, and biotech industries are concerned about their inability to consistently ensure the supply of incoming materials. This article offers recommendations for good supply practices - assembled by a team of FDA officials and industry professionals - that reduces the risk to finished product quality, patient safety, and business success.

  9. Flip The Org Chart: Rethink Where A Pharma Company's Focus Should Be

    I had given a good manufacturing practice (GMP) refresher session in a company whose mantra was efficiency and speed. After the session, a manufacturing operator talked to me about employees’ frustration with the situation, saying, "Why don't people understand that if we focus on doing things right, efficiency will come?"

  10. Traditional, MIS European Spine Devices Experiencing Continual Growth

    Traditional spinal fusion device markets continue to experience regular growth. This trend is applied across fixation devices, interbody devices, vertebral compression fracture (VCF) treatment, and other product segments. The major competitive limiters are expected to be minimally invasive devices and motion preservation. However, traditional devices currently enjoy a strong advantage over the latter in reimbursement and clinical research.