Medical Device Daily European Correspondent

The market potential for the new, so-called combination products has companies searching the globe for innovative applications that can follow on the path opened by drug-eluting coronary stents.

The applications of bio-reactive materials linked with medical devices holds a potential for added value while also pushing forward the larger, potentially blockbuster, opportunities for drug/device implants.

These opportunities include the extension to high-volume, disposable products such as wound-healing devices and techologies promoting skin growth; surgical sutures woven with fibers to fight infection; and, in orthopedics, the transformation of materials from inert replacements of bones and tissue to next-generation materials capable of fusing with surrounding tissues or disappearing altogether.

But the marriage of biology with the mechanics of medical devices — increasingly referred to as convergence — is not for the faint-of-heart.

The enthusiasm for these emerging opportunities across multiple medical market segments was tempered by the experiences of companies presenting during last week's BioDevice Partnering 2007 conference in Zurich, Switzerland.

Darren Obrigkeit, head of licensing and ventures for DSM Biomedical (Heerlen, the Netherlands), estimated that two out of three partnerships in this field go bad in the first two years after their launch.

In the past 12 months DSM acquired three biomaterials companies as it pursues an aggressive growth strategy.

Alessandra Pavesio, director of R&D for Fidia Advanced Biopolymers (Abano Terme, Italy), also added a note of caution for potential partners, saying that the complexities in this field are twofold: both in product being developed and in the number and variety "among the actors bringing these products to market."

To better manage their risk, large companies with the muscle to market these innovative products tend to join product development at a later stage of the process, she said. This explains the dominance of small- and medium-sized businesses out on the edge of device design for so-called combination products where mechanics and biology meet.

Obrigkeit ranked the risk in product development according to the familiarity of the market, and regulators, with a material or an application. Using known materials for a known application carries the lowest risk, he said, while the highest risk comes with combining new materials for new applications.

For this highest risk, "you are looking at clinical trials," he said.

Reprocessing existing and familiar materials into medical processes is the optimal approach, he said, though acknowledging that "the trend and the opportunity for blockbuster growth is with more sophisticated new materials."

As an example, he cited a DSM program creating implants that can be absorbed by the natural processes of the human body and ultimately disappearing.

"Everyone right now is looking for a really high-strength implant that is reabsorbable," he said, whether for microdevices such as coronary stents or larger-scale spinal implants.

Pavesio described the emerging market opportunities as being primarily in diagnostic devices and the targeted delivery of therapies with disease-modifying properties.

"Materials used for interventions no longer need to be inert," she said. "They can be smart and reactive, they can be not only biofriendly but also bioactive and bioabsorbable. Some products are able to release goodies to the body to aid healing."

And at some point in the near future materials will become informative, she said, with diagnostics and even with software, such as are being seen today in the newest implanted insulin pumps.

Pavesio chairs a European Commission work group for the 7th Framework funding of research for regenerative medicine.

Citing the traditional division of regulatory responsibility for approval of medicinal therapies and medical devices, Don Long, executive editor of AHC Media and moderator of the panel session provoked discussion by asking the panelists to rank the ability of regulators to keep up with the rapid changes in the field of biomaterials.

Panelists gave varied marks to regulator knowledge, and Pavesio summarized by saying: "I would give the regulators high marks for their knowledge in these areas, but I would agree that the regulations are far behind the materials being regulated." As evidence, she cited a lack of uniform regulation on advanced therapies and mixed regulatory strategies worldwide.

Panelist Murray Height, chief technology officer for the Swiss start-up HeiQ Materials (Zurich), underlined the complexity in biomaterials product development from a single-product perspective.

"HeiQ is all about silver, our core focus," he said.

HeiQ produces a suite of powders with antimicrobial, antifungal, or UV protection functionalities embedded in an otherwise inert matrix of submicron diameter. The concentration of silver and its subsequent release can be tailored according to the application.

While silver is well known for its properties, he said, "The problem is the delivery — where it is needed and working it into the product," which so far has included programs covering a range from fibers and textile products outside the body, such as surgical gowns, to sutures, and then an equally complex range of in-body applications for net materials and scaffolds down to nano materials.

Pavesio presented experiences from the opposite end of the product development spectrum.

Fidia develops fibers and tissues designed to be directly associated with human cells. The company's lead product, Hylograft, is a tissue-engineered graft composed of autologus chondrocyte grown on a 3D nonwoven scaffold.

Considered the "gold standard" among biomaterials, according to Pavesio, Hylograft is an example of how the business model is changing where niche market opportunities tend to supercede the search for blockbusters.

The cutting edge for companies is to shift from a siloed perspective of bio-tech and med-tech development to a more virtual integration of the two industries.

"We are seeing more and more the association of technologies with engineers talking to biologists," she said.

Pavesio said the early stages of product development require a collaboration that is unfamiliar for many companies who tend to "pound a fist on the table and demand the work group gets to a specific endpoint."

DSM's Obrigkeit agreed that work teams need to have time "to make the biology work and the challenge to companies is to manage this risk, but not avoid it."

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