The landscape of medical device development is shifting rapidly. And it’s not just balancing innovative gains with safety that medical device companies must worry about anymore. Given that the medical device industry is slated to skyrocket to $1100 billion by 2030, there’s obviously a lot at stake. Globally, the medical device manufacturers are shifting from a transaction-based approach to an approach that involves focusing on creating value for providers, practitioners, payers, and patients by providing surgical instruments and medical tools that are highly cost-efficient, innovative, and speak volumes about the product quality. The medical device manufacturing industry is expected to grow by leaps and bounds owing to the rising aging population, increasing health concerns, and sky-rocketing health care costs.
Until fairly recently, software embedded within medical devices had limited functionality. Gradually, like so many products, software came to dominate the core features and functionalities of medical devices. That combination of quality hardware and sophisticated software has made medical devices a lot more complex, which equates with increased development work for those building the products.
The primary driver behind the high cost of new product development is the amount of time required to take an idea from conception to realization. By setting a solid foundation for a design project with clear and concise requirements specifications, these costs can be reduced, and organizations will realize faster “to-market” times and improved ROI. The major challenge for medical device manufacturers is to overcome the burgeoning cost of product development as a result of the challenges mentioned above. Besides technology and government regulations, medical service providers evaluate new products based on their price as against factors like patient experience.
We’ve discussed the importance of understanding who the design requirements process stakeholders are and including them early in the process. Your Regulatory and Quality team are essential contributors when it comes to addressing the challenges presented by the current medical device regulatory environment. Whether it’s ISO 14971 or ISO 13485, compliance with government and industry regulations remains a constant weight for medical device developers, as regulatory bodies struggle to stay current speed of the market. However, it’s important for all members of the team, especially engineers and project leads to have at least a high-level understanding of the requirements, as you will likely encounter issues impacted by the regulations throughout the design process.
In the emerging markets, local medical device manufacturers are more successful as compared to their multinational counterparts. This is possible because the local players offer tailor-made products aimed at resolving local needs and constraints. The local medical equipment manufacturers often indulge in market research and leverage the benefits of local operations and a domestic sales force to bridge the gaps in the market
As the Internet-of-Things (IoT) becomes more and more integrated into society and more devices are carrying consumers’ important personal data, privacy and trust is an increasing security challenge for medical device companies. Requirements surrounding technology and data integrity were also noted in section 1., above, as an example of an important consideration for the early stages of the product design/requirements process from a cost-savings perspective.
Along with regulatory agency enforcement actions and data breaches, product recalls are another way in which a company’s brand and bottom-line can be quickly and devastatingly damaged. This introduces new risks for those tech companies with non-traditional FDA-regulation backgrounds and creates fresh challenges for the FDA’s evaluation of each software solution, which has prompted an overhaul of that system. More significantly, poor product quality can lead to serious end-user injuries or even death. While even the most basic medical devices face these challenges, newer, more technologically-advanced products are at an even greater risk. For a medical equipment manufacturer, product recall negatively impacts its brand reputation and the company’s bottom line. Thus, ensuring adequate product safety, security and reliability are extremely crucial to survive the competition in the emerging markets.
- Regulatory strategy requirements
- Requirements surrounding technology and data integrity
- Sales and Marketing Requirements (especially any claims substantiation considerations – these need to be known upfront to establish any additional testing requirements)
- Other “customer” needs, such as those required by health care providers and insurers as the healthcare industry focuses more heavily on outcomes and demonstrating effectiveness
- Interoperability with other devices or information systems
- Education of customers regarding the device, technology, data security, advantages and cost savings
- Potential intellectual property roadblocks
Having a clearly defined, efficient process for requirements planning is even more important in today’s highly competitive medical device industry – organizations need to be more responsive to customer needs in a more efficient and effective manner than their competition. The keys to making this happen are to ensure you include all those who have a stake in the process, along with streamlining the requirements process and using tools that ensure accurately defined requirements are developed from the beginning.