With today’s 21st Century technology and the speed and accessibility of data or information from the internet, medical device manufacturers are faced with unique — and at times unprecedented — trends in meeting consumer needs as well as global regulatory requirements. As the demand for medical products and services are expected to rise as a result of the expanding and aging global population, today’s more health-conscious society brings with it a new type of consumer.
Consumers are now becoming more proactive and educating themselves more in matters concerning their personal health or wellness and are actively looking for alternatives in remedying their conditions. This can be seen by increasing numbers of patients who are more actively involved with their healthcare providers in the decision-making process and are very accustomed to asking for the latest device. This rising consumerism leads to preferences for devices or diagnostics that are more “user-friendly,” extremely reliable and built to last.
What this means to medical device manufacturers is a return to the “basics” of simpler, robust designs. Products are no longer being designed to focus on clinical uses, but rather by average consumers for in-home care options. Diagnostic tests are also being re-designed for more reliability and interpretation of results and convenient use. In addition, the Internet and mobile communication devices provide patients and physicians easy access to healthcare information available from web sites.
For manufacturers, challenges in meeting these consumer demands have lessened their interests for external suppliers that provide specialized components or processes while expanding their interests to those with parts or services that are more common or “generic” and readily available among multiple suppliers for competitive pricing and regional availability.
Unlike several years ago, device manufacturers capitalized on highly innovative designs which often required “niche” or specialized suppliers. Devices with highly customized features or functionalities that consumers found to be appealing at first were often found later to be too complex, too cumbersome or too poorly designed for everyday use.
Also, in meeting other consumer preferences and still maintaining their competitive market standing, device companies are looking to emerging technologies for non-invasive devices — for example, imaging and laparoscopic technologies. These technologies, along with the aid of smart phones and other mobile communication devices, give rise to the use of mobile medical device applications for a wide range of functions such as allowing consumers to monitor their calorie intake in managing a healthy weight or physicians to view their patient’s X-ray results without necessarily being tied to the constraints of a desktop computer or office.
As a result of these consumer demands and emerging technologies, additional pressures are being placed on health regulators to maintain the balance of supporting innovation while assuring safety and effectiveness for these new devices and applications. FDA’s 2011-2015 Strategic Initiatives and recent Draft Guidance for Mobile Medical Applications — released on July 19, 2011 — reflect their more vigilant commitments to consumer safety and product quality. Additionally, recent 483 warning letters issued by FDA to device manufacturers express greater expectation and emphasis for companies to apply a “Quality by Design (QbD)” approach incorporating risk management principles. Regulators expect device manufacturers to be exercising a more proactive system of compliance.
In light of these changes, manufacturing facilities and critical suppliers should implement infrastructures that require constant feedback throughout the product lifecycle, from early product development through post-market. The structure forces device companies to reevaluate their existing operations and adapt fairly quickly in order to meet current and future regulations. Additionally, as these interpretations and applications of regulations evolve, companies need more sophisticated software solutions to maintain compliance-specifically, oversight of their global supply chain processes. Paper-based, manual systems are fast becoming obsolete.
As companies continue to grow while focusing on operational efficiencies and effectiveness, they must also be searching for creative solutions in parallel to support services and data analytics to truly be effective in maintaining and evolving industry and compliance standards. A steady increase of product recalls over the past decade is a prime example of this need.
Also, as further example of commitment for consumer safety, FDA’s 2011-2015 Strategic Initiatives outlines plans to require additional data collection throughout the product life cycle to control risk, and mandates greater collaboration with other regulatory partners, as well as insurance providers, to further improve product safety. The FDA has proposed a program similar to the pharmaceutical industry’s Risk Evaluation and Mitigation Strategy (REMS), which ensures that the benefits of a specific drug outweigh its associated risks.
Enterprise solutions that were primarily designed for managing more of the “business” aspects of the product lifecycle such as inventory and supply chain management are no longer sufficient by themselves. There must also be an in-depth, comprehensive quality management system that is designed to survive the scrutiny and challenges of more stringent regulatory inspections.
As device companies continue to focus on enhanced technologies and cost efficiencies in materials and design, there will continue to be wide-ranging impacts for both device manufacturers and regulators to consider as they are tasked with having to find unique enterprise solutions to effectively manage product development and business operations in a highly competitive global market.
This article was written by May Sayco, the Industry Solutions Director at Sparta Systems, a leading gmp auditing software provider. She has over 18 years of life sciences experience including positions at Pharmaceutical companies such as Schering Plough, Johnson and Johnson and Integra Life Sciences. May is primarily responsible for the strategic direction of Sparta Systems medical device initiatives as well as the facilitation with cross-functional teams in support of executing these strategies.