Whitepapers

Whitepapers

Medical Products Whitepapers



Commercial Challenges in Developing Biomaterials for Medical Device Developement

Secant Group researchers Jeremy Harris, Steven Lu, and Peter Gabriele recently published an article in International Polymer magazine discussing the challenges of conceptualization through market adoption of a new biomaterial. 
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Secant Group Featured in Medical Design Briefs

Secant Group is featured in Medical Design Briefs.  The article, “Innovations in Textile Engineering and Advanced Biomaterials”, discusses the use of textile design engineering and biomaterials to improve regenerative medical implants. 
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Commerical Challenges in Developing Biomaterials for Medical Device Development

From initial conceptualization through to market adoption, the introduction of new technology into a commercial market is often fraught with challenges. In the field of biomaterials these challenges manifest themselves at every step of the commercialization process. As the understanding of the mechanobiologic relationship in tissue engineering has progressed, there is greater emphasis being placed on the engineering of specific properties into new biomaterials. During this early development, intellectual property is a critical factor in determining commercial feasibility as patent protection establishes the property lines around the technology and helps define future market segments. Once developed, a new biomaterial then enters the next series of challenges including commercial‐scale manufacturing and addressing regulatory concerns. Synthesis of the biomaterial must be economically and technically scalable to meet market demands and the new biomaterial must be designed to stand up to regulatory scrutiny with regards to safety and efficacy. However daunting, a robust understanding of the design elements and the commercial requirements will aid the researcher in overcoming the challenges of bringing a new biomaterial to the market.
© 2018 Society of Chemical Industry
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Regenerez®: A Next-Generation Meterial for Bioresorbable Coatings

Coatings consisting of natural and synthetic origin play a major role in the world of medical devices both from a functional and a biological perspective. Collagen and similar materials are often used to coat surgical meshes to minimize the formation of intra-abdominal adhesions following hernia repair procedures. Coatings are also applied to cardiovascular grafts to provide a blood-tight structure until the graft is populated with host tissue. A coating made from a material that provides a beneficial mechanical and biological response would be an invaluable asset to medical device engineers.Regenerez , a bioelastomer made with poly(glycerol sebacate) (PGS) has shown tremendous promise in the field of tissue engineering and regenerative medicine, and it is an ideal coatings candidate due to its elastomeric and cell-friendly properties.1,2
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The Importance of Regenerez® Antimicrobial Activity

Almost all biomaterials are foreign objects that are introduced into the body in the form of an implantable device; the area near the implant becomes immunologically compromised and is a nidus for infection. The role of the biomaterial may be crucial to preventing or reducing the severity of a device-associated infection. Over the last decade, the number of materials implanted into patients as either catheters or devices has skyrocketed. This has created a critical need for biomaterials that possess antimicrobial activity to prevent the prevelence of biomaterials-associated infections.
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Laser Redirected Infrared Analysis (LDIR): A new IR imaging technology to study functional group spatial relationships in PSA adhesive surfaces

The significance of this work demonstrates the utility of LDIR to surface analysis and the exploration of material mechanisms. It also demonstrates that revisiting classic research with a new set of tools can offer the researcher new viewpoints. It is the picture of the interaction of matter that makes this imaging technique of value to the researcher.
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Regenerez®: A Next-Generation Material for Functional Bioresorbable Coatings

Coatings consisting of natural and synthetic origin play an important role in the world of medical devices both from a functional and a biological perspective. Collagen and similar materials are often used to coat surgical meshes to minimize the formation of intra-abdominal adhesions following hernia repair procedures. Coatings are also applied to cardiovascular grafts to provide a blood-tight structure until the graft is populated with host tissue. A coating made from a material that provides a beneficial mechanical and biological response would be an invaluable asset to medical device engineers. Regenerez™, a bioelastomer made with poly(glycerol sebacate) (PGS) has shown tremendous promise in the field of tissue engineering and regenerative medicine, and it is an ideal coatings candidate due to its elastomeric and cell-friendly properties.
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Fiber and Textile Innovations Pave the Way for Device Advancement

Much of the advancement of the MIS market can be attributed to technology developments in the materials science and textile processing industries, as evidenced by a partnership between biomaterials leader DSM and Secant Medical, a leading designer, developer and manufacturer of biomedical structures. The companies are using unique biomaterials, along with device component constructions that feature new property and performance characteristics. This combination enables previously inconceivable design developments, particularly in the cardiovascular and neurovascular fields.
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Regenerez®: How the Incorporation of Regenerative Materials Will Advance Biomedical Textiles

To explore the recent trends and the future direction for the development and commercialization of biomedical textiles in regenerative medicine, it is necessary to look at some areas in which their uses are expanding as well as an ongoing success story in which a material is moving from bench top to market. This paper reviews the use of biomedical textiles in light of the generational scheme of biomaterials, outlines crucial success factors for bringing projects out of university labs and into commercial use, and discusses how Secant Medical’s advanced biomaterial, Regenerez®, fits within this evolution.
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Regenerez® Elastrometric Properties

Elastomers serve in a variety of medical applications including tissue engineering and implantable devices due to their ability to bend and stretch, mimicking native tissue. Medical devices make use
of elastomeric materials’ viscoelastic properties to allow these devices to bend and flex with the body. This imparts many advantages including increased range of motion and patient comfort, device longevity, and improved biocompatibility. Regenerez®, poly(glycerol sebacate), is a bioresorbable elastomer with tunable properties that have been cited in a variety of regenerative medicine applications, including wound healing, bone grafts, cardiovascular grafts, coronary stents, and guides for nerve repair.
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Regenerez®  Degradation and Release Kinetics

Implantable biomaterials play a critical role in medical applications such as, cell therapy, regenerative medicine, tissue replacement, and biomedical devices. Of particular interest is the use of biomaterials in drug delivery systems. Implantable devices for sustained drug release offer advantages in patient compliance because the treatment regime can be less taxing than pills or injections. Some areas of application include pain management, contraception, diabetes maintenance, HIV treatment and prevention, as well as targeted controlled delivery for neurology, cardiology, ophthalmology, and oncology.
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