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SmartTRAK Life Sciences News and Analysis Blog

Jay Merkel

Senior Analyst - 20+ years’ commercial experience in the medical device and technology industries including senior and executive roles at both start up and large organizations such as Integra Life Sciences, BD, Olympus Inc. and B. Braun Medical.

Recent Posts

2 min read

Negative Pressure: Still Innovating, Growing and Expanding

By Jay Merkel on 12/17/24 9:13 AM

SmartTRAK examines the market dynamics, innovations and growth drivers for Negative Pressure Wound Therapy.

Since KCI (now  Solventum) introduced the wound V.A.C. to the market in 1996, traditional Negative Pressure Wound Therapy (tNPWT) has become the standard of care in hospitals for the treatment of hard-to-heal wounds .  While tNPWT has and will continue to experience low-single-digit revenue growth over the next several years, most of the growth in this space has been in single-use NPWT (sNPWT). According to SmartTRAK's US External Devices Market Overview, the US Market for sNPWT is forecasted to grow at a 5-year CAGR of roughly +13%
 

In this article, SmartTRAK provides an overview of the market dynamics impacting both the tNPWT and sNPWT segments of the US External Devices Market, including:

  • Traditional Negative Pressure
    • Solventum and Smith+Nephew (SNN) are two key players in the tNPWT category, with a combined US market share of almost ... (read more)
  • Single-Use Negative Pressure
    • Like the tNPWT market, both Solventum and SNN are key players in the sNPWT segment, together owning the vast majority of the market. sNPWT has been attracting a lot of interest from wound care companies, large and small, due to its sustained double-digit growth globally. SmartTRAK identifies and discusses three market strategies that are currently playing out in sNPWT as companies position themselves to capture share in this fast-growing segment. They are:
      • Large Dressing Companies Expanding into the sNPWT Adjacency
      • Start-Ups Focus on Pump-Free Products.
      • Growing the Market Through Expanded Use, Clinical Evidence ... (read more)

Click the button below to access and read the complete "Negative Pressure: Still Innovating, Growing and Expanding" article by Jay Merkel, SmartTRAK Sr Analyst, which highlights key large studies on the use of sNPWT in 2024, breaking them out into the studies that show benefits and the studies with moderate or no benefits. Get the Article

Topics: Wound Care NPWT
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3 min read

SAWC Spring 2024: Highlighting the Hot Topic of Skin Substitute Reimbursement

By Jay Merkel on 6/19/24 11:55 AM

The proposed MAC LCDs for Skin Substitutes/CTPs was the hot topic of SAWC and will continue to be until the LCDs are finalized. In this article, SmartTRAK highlights new learnings from discussions at SAWC and the MAC open meetings.

The Symposium on Advanced Wound Care (SAWC) Spring 2024 meeting welcomed clinicians, researchers and industry to Orlando, FL, to learn, earn continuing education credits, share knowledge and network on the latest developments in advanced wound care. As is typical during SAWC, the Alliance of Wound Care Stakeholders also held a meeting of their members. With the Medicare Administrative Contractors (MACs) recently announced proposed changes in the Local Coverage Determination (LCD) governing Skin Substitutes/CTPs (cellular and/or tissue-based products), the Alliance pivoted and invited an expert to speak to the group about how the LCD process works and what laws govern what can be done at the MAC level versus the Center for Medicare & Medicaid Services (CMS) levels. Kudos go out to the team at the Alliance for bringing this meeting together. In addition to the Alliance meeting at SAWC, the MACs held open meetings for these LCDs from May 16 to May 29, and anyone, including manufacturers, could present comments, make a request and provide evidence. SmartTRAK participated in several of these meetings.

In this downloadable article, SmartTRAK gives an overview of LCDs, how they are drafted, the coverage limitations by wound type, issues surrounding evidence for inclusion on the covered list and an implementation timeline. For more information on what the proposed LCDs cover, see also “Medicare Administrative Contractors’ (MACs) LCD Changes: Impact on Skin Substitutes/CTPs.

The following subjects are covered in detail in this downloadable article:

  • The Process for Drafting LCDs
    As background, CMS governs the process for drafting the LCDs in their Medicare Program Integrity Manual (PIM) in Chapter 13, which was most recently updated in 2019 with almost every section re-written. These changes include ... (read more)

  • Coverage Limitations
    The LCD is a literal guide to what is allowed and, conversely, what is automatically denied within the limits written in the LCD. The LCDs for Skin Substitutes/CTPs are for ... (read more)

  • Missing or New Evidence and Reconsiderations
    One area that generated the most questions from manufacturers was how to address coverage decisions if the MAC working groups are missing recently published evidence or have evidence currently in development. The comment submission period was ... (read more)

  • Timeline for LCD Implementation
    During the MAC open meetings, participants had several questions regarding the timeline for LCD implementation, and some requested a delay in implementation. The following timeline applies to all LCDs ... (read more)

Just click the button below to download and read the complete " SAWC Spring 2024: Highlighting the Hot Topic of Skin Substitute Reimbursement " Perspective article by Jay Merkel, SmartTRAK Sr. Analyst.
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