A 61-year-old grandmother with a debilitating spine injury lies in the operating room undergoing surgery to receive an innovative synthetic bone graft substitute. Regaining enough function to lift her grandchild and having the ability to interact with her family again could mean everything to the patient. To bring a solution that enhances her quality of life means creating novel biomedical materials, while delivering them with value. Yet, the complexity and cost of developing these new technologies can overwhelm a medical device company’s in-house staff.
Therefore, aligning with a strategic partner with broad research and development (R&D), manufacturing and materials expertise, regulatory support, and marketing capabilities can efficiently expand internal resources. This allows medical device developers to innovate as nimbly as a startup, and scale-up production and distribution as quickly as an industry giant.
Hear what my DSM colleague and President of DSM Biomedical has to say regarding the importance of providing value to the medical device industry, not just innovation.
Expand R&D scope and expertise
R&D teams are increasingly experiencing pressures to innovate faster, while managing costs effectively. Therefore, new models are needed to accelerate product development. Partnering can expand the capabilities of existing teams with a broad base of experts, and even tap into new areas of innovation, increasing R&D efficiencies. For instance, engineering specialists have knowledge in the latest technologies in design, fabrication and implementation for specific biomaterials and products – and often welcome the challenge of working with medical device companies to help identify the appropriate materials or to develop new biomaterials to meet customer needs.
In addition, deep expertise in the healthcare industry can give final products quality and performance advantage over competitors. The right partner understands the clinical needs and end-uses of products. These insights can assist in developing design inputs and simulated-use tests, creating a better way to reformulate or develop chemistries for new materials or improving existing ones.
Manufacturing expertise to meet stringent regulatory standards
Many medical device companies struggle with stringent regulatory approvals to get products to market. Partners with a dedicated regulatory staff can help device companies comply with the global medical device regulations, enabling faster time to market. Large development organizations are set up to have flexible manufacturing processes in place to respond and adapt to changing markets and evolving product requirements. Often partners can implement a regulatory strategy that includes developing clinical investigational plans, clinical trial management and strategic consulting.
Market launch assistance
Launching new products represents a big investment for companies, and with it comes many challenges including planning, communication and implementation. To facilitate a product from conception to commercialization, device developers need to choose a partner that not only has strong clinical and industry knowledge, but also has extensive product launch experience. A partner’s ability to tailor sales training programs to support product launch activities can accelerate market access, save time and resources, and position a commercial organization to secure the market.
In closing, with downward pricing pressures in the medical device industry, paired with the unsustainable costs of healthcare, adopting a holistic partnership that can deliver innovation with value can help medical device companies gain share in increasingly competitive markets. Companies can leverage a partner’s expertise in the latest technologies, regulatory strategy and market applications to scale up without compromising quality and to accelerate product commercialization. Partnerships based on transparency, openness and collaboration will succeed—whether to develop a new material, component or device—in ultimately creating a better quality of life for patients and their families.
By Kevin Cooney, Director of Product Marketing, DSM Biomedical