Advanced Wound Care and Wound Management

Overview

Based on product, the advanced wound care (AWC) and wound management (WM) market is segmented into advanced wound dressings, topical agents, surgical wound care/wound closure, and wound therapy devices.

In recent years, the number of surgical procedures has been on the rise and the prevalence of chronic diseases has also increased across the globe, which has resulted in a surge in the demand for advanced wound care and wound management products. Additionally, the rising incidence of diabetes as a result of a sedentary lifestyle is one of the primary factors contributing to the upsurge in demand.

Other factors influencing the growth of this industry sector, include aging populations, the increasing number of ambulatory surgical centers, and the prevalence of target illnesses such as leg ulcers.

The rapid growth of the sector is highlighting a long list of technical challenges, such as those relating to approved modalities and the supply of sterilization, further complicates the supply of products. Additionally, as our global population grows and ages, demand often increases out-of-step with available budgets, which inevitably results in an almost constant drive towards cheaper and/or more efficient solutions. Global high inflation has also impacted production and transportation costs, making it more difficult than ever before to ensure the profitable supply of critical medical technologies

Male & female scientist
Micoroscope and bacteria

Challenges when testing antimicrobial dressings

Current standards for testing antimicrobial wound dressings are regularly required to be modified to reflect the wound condition, which results in a re-validation of the method.

In vitro testing of wound dressings is complex due to the construction of different dressings; consequently, it is difficult to develop a test method that is suitable for all dressing types. The variability in wound dressing construction can also affect how the active agent may be made available.

Multi-species In vitro microbiology models create complexity due to how selected organisms interact and co-exist. This can create variability in results.

Given the physiological complexities that exist in chronic wounds and the variations in type and construction of wound dressings, significant challenges exist in developing representative,
robust, and reproducible in vitro models for testing wound dressings.

Challenges in accessing sterilization capacity

Global supply chain shortages, e.g., ethylene oxide sterilization facility shutdowns and raw material scarcity, continue to impact the availability of sterilization capacity within the medical technology industry.

Increasing regulatory demands governing Cobalt-60 use, supply chain costs, supply chain shortages, the time needed for gamma sterilization, and ethylene oxide sterilization facility shutdowns are key aspects triggering the switch to e-beam or X-ray radiation alternatives. However, some obstacles make it difficult for manufacturers of medical devices to navigate this transition.

One is a knowledge gap in how the different radiation sources (e-beam and X-ray irradiation) affect common medical device materials. Also, the irradiation effects on materials for all modalities must be documented to progress the use of different irradiation modalities.

Complexity around understanding coverage and reimbursement options for wound care dressings

There is increasing difficulty to be involved in wound care at any level, without working knowledge of the intricacies of various policies regarding wound dressings.

The following factors must be considered:

  • Care setting
  • Medicare Administrative Contractor for your geographic region
  • Durable Medical Equipment (DME) local coverage determinations
  • Type of dressings desired
  • Wound assessment

The development of reimbursement guides to help simplify coverage guidelines and documentation requirements would benefit the wound care industry.

Complexity around understanding coverage and reimbursement options for wound care dressings

It is becoming increasingly difficult to be involved in wound care at any level without a working knowledge of the intricacies of various policies regarding wound dressings. Care setting, Medicare Administrative Contractor for your geographic region, Durable Medical Equipment (DME) local coverage determinations, type of dressings desired, and wound assessment are all factors that must be considered.

The development of reimbursement guides to help simplify coverage guidelines and documentation requirements would benefit the wound care industry.

Digital Ring

An open and safe environment to facilitate industry wide collaboration in wound care

The MediPhorum AWC & WM segment focuses on addressing the challenges associated with   these devices, providing a safe and open environment for wound care organizations to enhance effective collaboration and develop progressive solutions to shared industry challenges.

MediPhorum enables wound care leaders to share knowledge and experience in a safe, collaborative environment, allowing the simplification of complex industry processes and challenges for the benefit of all.

By working together to develop consensus views and best practice approaches to solve problems, MediPhorum aims to help the wound care industry to supply these important products to more patients worldwide.

Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, Filing and Review, Interactions with Health Authorities, and Harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more
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