Accelerating innovation for medical device companies

To deliver on this and provide greater clinical efficacies, the company has invested in clinical-study expertise, component manufacturing facilities and component testing.

The innovator of implantable PEEK-OPTIMA polymer is also launching a new website that efficiently provides information on materials and applications to OEMs and Health Care Professionals (HCPs), and a comprehensive journal with further scientific information and clinical evidence.

John Devine, Medical Business Director at Invibio Biomaterial Solutions explains the quandary of innovative medical device makers: “When faced with delivering a consistent quality of healthcare at the lowest cost, the market has yet to create an environment that encourages more ambitious solutions than simply preserving the status quo at a fractionally reduced price.”

Defining “best clinical outcomes” while delivering healthcare at the lowest possible cost is challenging, because clinical outcomes are typically obtained through clinical studies, which are expensive and time-consuming.

In addition, there could be variations in the level of clinical evidence by region and different types of stakeholders and their needs, which can, for example, depend on where they sit on the curve of the diffusion of innovation.

As a consequence, the medical device industry faces a difficult task, when seeking to demonstrate that new product innovations are addressing these issues and, ultimately, improving patient care.

John Devine sums it up: “The majority of current cost metrics focus on up-front purchasing costs rather than the total cost of care. For example, no standards exist for accurately assessing complication rates, or measuring the cost of revision surgeries, and reflecting these in purchasing decisions.”

As a leading pioneer in the use of PEEK-OPTIMA polymer solutions in medical applications, Invibio is convinced it can deliver the greatest clinical and economic benefits in four key areas, Dental, Spine, Orthopaedics and Trauma.

To help raise its own bar for patient care and provide even greater clinical efficacy, Invibio recently recruited a clinical study manager and is working with Health Care Professionals (HCPs), medical device manufacturers and other stakeholders to determine the clinical and economic impact of its solutions.

The company has also brought in clinical relations expertise to interact with HCPs, hospitals and payers. Martin Court, Executive Director at Victrex, emphasises: “Doing so ensures that the clinical evidence we develop is not only shared in the marketplace, but accurately supports the benefits our materials can offer patients and the entire healthcare community.” As a result of these enhanced research and clinical data capturing efforts, Invibio has become more certain of the effectiveness of its solutions.

In addition, the company´s investments have made it easier for medical device companies to innovate and change the way they develop new products. Court continues: ”Our investment in component manufacturing facilities and component testing, for example, gives us a greater role in the design, development and commercialisation of trauma fracture plates made of PEEK-OPTIMA Ultra Reinforced, a carbon-fibre-reinforced polymer".

"We have also pledged more support for our customers’ new product development programmes. In addition, we are continuing to help customers worldwide navigate the challenging, regulatory pathway toward product safety and efficacy. It’s a win-win for Invibio, our customers, and patients alike.”

Invibio is also launching a new comprehensive annual journal, the “Invibio Insider”, the first edition of which offers a detailed insight into key topics that will help to pioneer progress in the medical arena.

Focused topics are intended to provide a greater understanding of the levels of clinical evidence, and what that may mean in combination with the company´s strategic drive to improve patient and clinical outcomes.

It also explores approaches for treating challenging patients, taking into account the HCP’s perspective, and showcases recent clinical evidence while also discussing its potential economic impact.

The company´s new website will serve as a hub for OEMs and Health Care Professionals (HCPs) alike. For OEMs, it is a go-to practical and educational resource for implantable PEEK related knowledge and clinical data, including product offerings, manufacturing, quality and partnering for custom-design and regulatory services.

For HCPs, it aims to facilitate the clinical adoption of new medical devices made of the company´s high-performance polymer, by providing implantable PEEK-related knowledge, clinical data and information concerning the potential benefits of Invibio´s solutions for HCPs and ultimately their patients.

With a new emphasis on clinical evidence and an easy to navigate online academy, Invibio is not only addressing the needs of different target groups, but also hoping to contribute to achieving the best possible clinical outcomes and lowering the total costs of care.