Regulatory science promotes the translation of transcatheter tricuspid valve repair/replacement devices.

For patients with symptomatic and severe tricuspid regurgitation but inoperable with open surgery, transcatheter tricuspid valve intervention (TTVI) is a procedure of great clinical value. TTVI products include repair and replacement devices. TTVI products are one of the hotspots of investigation now, with different innovative biomaterials and structural designs in trials to satisfy divergent indications and reduce complications. With the emerging biomaterials, the technical difficulty of structural design will be greatly reduced, spurring further product innovation and development. The innovativeness and complexity of TTVI products have brought challenges to academia, industry, and regulatory agencies. Regulatory science provides a bridge to address these difficulties and challenges. This perspective article introduces the latest development of the TTVI products. With traditional methods, regulatory agencies face challenges in evaluating the safety and efficacy of TTVr/TTVR devices given the uncertainty of clinical use and the diversity of innovative structural design. This perspective article analyzes the regulatory challenges and discusses regulatory science that can be developed to assess the safety, efficacy, quality and performance of such products: including new approaches for innovative devices, pre-review path, computer modeling and simulation, accelerated wear testing methods for transcatheter heart valves and evidence-based research. This article reveals for the first time how to apply regulatory science systematically to TTVI products, which is of great relevance to their development and translation.

Status and developmental trends in recombinant collagen preparation technology.

Recombinant collagen is a pivotal topic in foundational biological research and epitomizes the application of critical bioengineering technologies. These technological advancements have profound implications across diverse areas such as regenerative medicine, organ replacement, tissue engineering, cosmetics and more. Thus, recombinant collagen and its preparation methodologies rooted in genetically engineered cells mark pivotal milestones in medical product research. This article provides a comprehensive overview of the current genetic engineering technologies and methods used in the production of recombinant collagen, as well as the conventional production process and quality control detection methods for this material. Furthermore, the discussion extends to foresee the strides in physical transfection and magnetic control sorting studies, envisioning an enhanced preparation of recombinant collagen-seeded cells to further fuel recombinant collagen production.

Plain metallic biomaterials: opportunities and challenges.

The 'plainification of materials' has been conceptualized to promote the sustainable development of materials. This perspective, for the first time in the field of biomaterials, proposes and defines 'plain metallic biomaterials (PMBs)' with demonstrated research and application case studies of pure titanium with high strength and toughness, and biodegradable, fine-grained and high-purity magnesium. Then, after discussing the features, benefits and opportunities of PMBs, the challenges are analyzed from both technical and regulatory aspects. Regulatory perspectives on PMB-based medical devices are also provided for the benefit of future research, development and commercialization.

Progress and prospect of technical and regulatory challenges on tissue-engineered cartilage as therapeutic combination product.

Hyaline cartilage plays a critical role in maintaining joint function and pain. However, the lack of blood supply, nerves, and lymphatic vessels greatly limited the self-repair and regeneration of damaged cartilage, giving rise to various tricky issues in medicine. In the past 30 years, numerous treatment techniques and commercial products have been developed and practiced in the clinic for promoting defected cartilage repair and regeneration. Here, the current therapies and their relevant advantages and disadvantages will be summarized, particularly the tissue engineering strategies. Furthermore, the fabrication of tissue-engineered cartilage under research or in the clinic was discussed based on the traid of tissue engineering, that is the materials, seed cells, and bioactive factors. Finally, the commercialized cartilage repair products were listed and the regulatory issues and challenges of tissue-engineered cartilage repair products and clinical application would be reviewed.

Functionalization of biomedical materials using fusion peptides for tissue regeneration.

Tissue development deformity or tissue defect is a major clinical challenge. Tissue engineering technology provides a promising solution to these problems. Among them, functional biomaterials with regenerative abilities are one of the development trends. Polypeptide is a small molecule that can be used to modify tissue engineering materials. However, the function of a single polypeptide molecule is limited and insufficient to construct comprehensive microenvironment for tissue regeneration. Fusion peptides combining two or more polypeptide molecules with different functions were expected to achieve multiple efficaciesin vivo, providing a novel solution for clinical tissue regeneration engineering applications. This paper reviews the construction methods, degradation process, and biological activities of fusion peptides, and presents recent global research progress and prospects concerning fusion peptides. It provides a reference helping to guide the future exploration and development of fusion peptide-based functional biomaterials for tissue engineering.

A regulatory perspective on recombinant collagen-based medical devices.

As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the definition, translation, classification and technical review. Recombinant collagens are categorized as recombinant human collagen, recombinant humanized collagen and recombinant collagen-like protein, as differentiated by specific compositions and structures. Based on their intended uses and associated risks, recombinant collagen-based medical devices are generally classified as Class Ⅱ or Ⅲ in China. The regulatory review of recombinant collagen-based medical devices aims to assess their safety and efficacy demonstrated by scientific evidences generated from preclinical and clinical evaluations. Taken together, opportunities as well as challenges for their future clinical translation of recombinant collagen-based medical devices abound, which highlights the essential role of regulatory science to provide new tools, standards, guidelines and methods to evaluate the safety and efficacy of medical products.

Regulatory perspectives of combination products.

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product. The product research and development, clinical translation as well as regulatory evaluation of combination products are complex and challenging. This review firstly introduced the origin, definition and designation of combination products. Key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented. Preclinical and clinical evaluation of combination products was discussed. Lastly, the research prospect of regulatory science for combination products was described. New tools of computational modeling and simulation, novel technologies such as artificial intelligence, needs of developing new standards, evidence-based research methods, new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety, efficacy, quality and performance of combination products. Taken together, the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

Regulatory considerations for animal studies of biomaterial products.

Animal studies play a vital role in validating the concept, feasibility, safety, performance and efficacy of biomaterials products during their bench-to-clinic translation. This article aims to share regulatory considerations for animal studies of biomaterial products. After briefly emphasizing the importance of animal studies, issues of animal studies during biomaterial products' translation are discussed. Animal studies with unclear purposes, flawed design and poor reporting quality could significantly reduce the translation efficiency and create regulatory challenges. Regulatory perspectives on the purpose, principle, quality and regulatory science of animal studies are also presented. Animal studies should have clear purposes, follow principles of 3R+DQ (replacement, reduction, refinement, design and quality) and execute under an efficiently operating quality management system. With the advancement of regulatory science, National Medical Products Administration of China has been developing a series of standards and guidance documents on animal studies of medical devices. Case studies of making decisions on whether to conduct animal studies are provided in the end with drug-eluting stents as examples. In summary, animal studies of biomaterial products should pay close attention to the rationale, design and quality in order to achieve their purposes.