To sustain profits in existing end-user markets, original equipment manufacturers (OEMs) of neuromodulation medical devices need to adopt a value-driven business model with growth strategy centered toward continuous differentiation and transferring cost efficiencies across the value stream, according to a recent report from .
The increasing regulatory scrutiny on implantable devices and demand for more clinical evidence is further compelling OEMs to direct their channel growth initiatives toward improving sales of existing or new products in mature markets.
Transition toward patient-centric care demand OEMs to explore successful partnerships with new resources such as investors, consumer electronics firms, ambulance agencies, and individual counseling psychologists, the report states. This will help OEMs to sustain channel growth and product premium in established markets, it continues. With these goals in mind, OEMs are striving to integrate social, mobile, analytics, and networking applications toward offering therapies that can deliver connected and collaborative care.
The report found that top OEMs focus on single-source suppliers to help them improve operational efficiencies, and it is crucial to balance compliance on quality of care across the value chain. OEMs are enthusiastic about implementation of e-commerce and operational analytics, poised to demonstrate cost leadership while developing customer relationships.
While most neuromodulation device OEMs have been focusing on reducing regulatory overheads while establishing safety and efficacy of existing and pipeline products for mature markets, many venture capital (VC) and private equity (PE) players in the medical device industry have been successful in exiting from promising start-ups. Accelerating the launch of competitive products and services for mature markets enable established OEMs to reinvest profits in acquiring innovative product portfolios, contributing to a healthy consolidation cycle in the industry.
“Industry consolidation in the form of acquisitions, joint investment with VCs, and bundling clinically demonstrated drug-device combinations, inclusion of nontraditional channel partners will enable OEMs to position products appropriately,” says Arjunvasan Ambigapathy, Frost & Sullivan TechVision industry analyst. “Additionally, continued VC investments will lower the entry barriers for nontraditional participants with innovative therapies for refractory conditions, such as Crohn’s disease, Parkinson’s disease, and rheumatoid arthritis.”
The entry of players offering minimal or noninvasive technologies and having strong intellectual property, regulatory approvals, and clinical data regarding therapies for chronic lifestyle disorders are more likely to fuel consolidation within the industry. Furthermore, the presence of reputed VCs and active involvement of late-stage PE firms are prompting OEMs to diversify their R&D investment risks by identifying early investment opportunities in innovative start-ups operating in commercially attractive markets.
Meanwhile, long entry timelines and unclear regulatory pathways in certain high-potential markets are intensifying the need to develop new local, culture-centric channels to drive the market growth of existing products, which might be approved by either the FDA or European Commission.
“Greater regulatory scrutiny and need for speedy approvals fuel the development of effective clinical data management solutions, which are reliable tools to communicate safety and efficacy of the therapies,” says Ambigapathy. “Predictive analytics tapping patient data and supplier productivity can help reduce compliance overheads, design population-centric care programs, and directly engage physicians or patients in co-creation initiatives.”