While the American medtech industry is thriving, it still must deal with challenges that include higher production costs, finding skilled staff and the ongoing issues innate to a highly regulated sector. Then there are global concerns such as competition, funding and the high cost of research. With Europe and the United States being the key markets, many U.S. medtech firms have located some of their operations in Ireland in order to take advantage of an established, flourishing life sciences sector, strong governmental support and easy access to the lucrative European market. Among the more than 300 companies with Irish facilities are Boston Scientific, Abbott, Vistakon, Medtronic, Teleflex, Stryker, Cook Medical, Zimmer Biomet, DePuy Synthes, Hollister, and BD. The medtech field in Ireland employs more than 32,000 people, which is the highest per capita in Europe. One-quarter of the world’s diabetics — 30 million people — rely on an injectable device manufactured in Ireland, while half of all ventilators used by acute hospitals worldwide are also made there. Meanwhile, three-quarters of global orthopedic knee products were produced in Ireland. There are several important reasons why American medtech companies have been choosing Ireland as their European base of operations, benefiting from Ireland’s manufacturing expertise, R&D facilities, pool of trained workers, data analysis skills, collaboration between companies, financial advantages, and regulatory advantages.
Read More →Benchmarks and Best Practices for Next-Generation QMS
In a recent study conducted for Pilgrim, quality and compliance professionals from the top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape of their current quality management systems (QMS). This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
Read More →The FDA’s New Approach to Digital Health
Recognizing that their traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the more rapid and iterative design, development, and validation phases used for software products, the FDA has created a new Digital Health Innovation Action Plan. One important piece of this plan is the “Software Pre-Certification (Pre-Cert) Pilot Program”. This pilot program, which began on September 1, 2017, is a voluntary program that will enable the FDA to develop a tailored approach toward regulating digital health technologies by looking first at the software developer and/or digital health technology developer, rather than the product. The purpose of this is to streamline the regulatory process for companies with a history of developing and testing quality products. Once pre-certified, that developer would be empowered to make software iterations and changes as needed. The nine participants that have been selected for the Software Pre-Cert Pilot Program are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. According to the FDA, these participants were chosen as they “represent a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers.”
Read More →Additive Manufacturing in Medical Devices: Insights from J&J and the FDA
One of the promises of additive manufacturing is the ability to go after niche markets with low volume production of unique parts. What application could be more apt for this technology than the human body? Last month, the FDA issued a statement providing guidance to manufacturers on technical aspects of additive manufacturing, clarifying what the FDA recommends manufacturers include on submissions for 3D printed medical devices. The FDA has, so far, approved over 100 3D printed medical devices, including knee replacements, custom skull/facial reconstructions, and even a 3D printed drug, called Spritam, which is used to treat seizures. The FDA has categorized this technical guidance as a “leap-frog” guidance, explaining that it is just a mechanism to share initial thoughts in order to bridge where we are today with the innovations of tomorrow.
Read More →Designing Medical Device Products for Emerging Markets: GEMBA, Jugaad, and Reverse Innovation – An interview with Palani Palaniappan, EVP at TerumoBCT
We were honored to have Palani Palaniappan, EVP Innovation & Development, of Terumo BCT, join us at the 2017 American Medical Device Summit, where he gave a plenary address on “The Democratization of Healthcare Technologies”. This is an excerpt from an interview with Palani, also on this topic. You can read the full interview here. Until now, corporations have served only the top tier of the world’s population: the top 2 billion. That leaves 5 billion people underserved. The underserved can maybe only spend $1 per day, instead of saying $100 in the developed world, but the sheer number of them make it profitable. By addressing these people and their needs, companies who have done it right have thrived. But many have done it wrong. A common mistake many companies make when designing products for emerging markets is that they simply defeature a product that is engineered to meet the needs of a developed economy. For instance, they will develop a product for the US market, then remove the more costly features to meet a price point they think will sell in a developing market, such as India or Africa. But achieving the right price point alone will not sell your product. You have to hit the right price point and 100 percent of the features have to be appropriate for the market. Companies looking to design medical device products for emerging markets should keep in mind three terms: Gemba, …
Read More →Ahead of the Curve: Disruptive Technologies in the Medical Device Market
Technia Transcat believes the medical device industry is continually evolving. Disruptive technologies are causing a paradigm shift in the development of new devices, influencing which businesses will enter this segment of Life Sciences, and who they will market their innovative devices to. In addition, what is also critical to the medical device industry is addressing the “Soft Business” disruptive modernizations. Organizations must implement internal processes and organizational behavioral changes in order to sustain a competitive advantage and continue to grow through organic means in an industry challenged with reducing costs associated with risks of regulatory compliance and certification of supply chain solidity. Technia Transcat and Generis have teamed up to create an ebook that explores how technology is changing the medical device industry and how to harness and embrace this technological change. To access the ebook, click here.
Read More →Common Obstacles to Receiving Product Approvals for Global Markets – An Ebook by CSA Group
As social, economic, technological and environmental factors changes at a rapid rate, so are medical devices and healthcare equipment. The consistent changes are bringing complex challenges that require manufacturers to keep up with the rapid pace of innovations, while still maintaining safety for both professionals and inexperienced home users. Many companies only have experience with single-country access and therefore may lack understanding and expertise of regulatory or technical requirements in other countries. With such a wide array of regulations from country to country, companies can struggle with how to begin the process of meeting the required conformity for their target markets. This issue can be compounded by a lack of internal resources dedicated to compliance issues. In this constantly changing environment of safety, conformity, and market access requirements, it is even more important to not only respond to the regulatory needs of today but anticipate those of tomorrow. CSA Group’s Ebook, Common Obstacles to Receiving Product Approvals for Global Markets, explores the common challenges and misconceptions in product approvals, the key stakeholders involved in the approval process, the geographical differences in the approval process, the role of a third-party testing agency, and clearing common hurdles to product approvals. To access the ebook, click here.
Read More →Recent Developments in the Use of Flexible Printed Circuit Boards in Implantable Devices – An Ebook
Over the past 50 years, life expectancy has been steadily increasing. The aging population, therefore, has steadily increased both in number and mean age. There are many neurological and cardiovascular diseases that can be best managed using implantable devices, reducing the need for medications. The key challenges for implantable medical devices are how to support low energy consumption, stable performance, and continued miniaturization. Implantable devices are not new. The pacemaker, as an example, has been around for more than 50 years. The early devices were cumbersome, with short battery life, so when the battery was low, the device had to be removed and replaced, putting a burden not only on the patient but also on medical services and the managed care system. Today these same devices are less than 3% of the size and weigh only a fraction of the former weight. The real revolution in the technology is not the size reduction, but the fact that today’s tiny implantable devices can be wirelessly monitored reducing check-up frequencies. Eltek has teamed up with Generis to create an ebook that looks at the history of implantable devices, the miniaturization of the devices, their wireless communications capabilities and their future. For more information on Eltek and to access the ebook, click here.
Read More →Cognition Ebook: Safety By Design
Cognition’s latest ebook “Safety by Design: Guided compliance for risk reduction in medical device production and commercialization,” explores how to mitigate risk during the device developmental process. The ebook looks at pressing topics such as understanding the challenges that surround the meeting requirements of the FDA and other regulatory bodies, FDA’s position on risk reduction and automatic traceability. When submitting for regulatory approval, companies need to demonstrate that they have used a well-defined, documented design control and risk management process in place, along with evidence that they are following it. Cognition’s Cockpit Platform provides templates that are configurable to meet common standards and regulations. To access the full ebook, click here.
Read More →Whitepaper: Smart Quality Management, Industry 4.0 and Quality Management Systems
In order to remain competitive in the rapidly-evolving Industry 4.0 landscape, most companies will be required to make technological changes. In the medical device industry, there are a number of unique considerations this technological change presents. This whitepaper, written by Pilgrim Quality Solutions and produced by Generis, explores the impact Industry 4.0 will have on the medical device industry, and how to make the shift to ‘Quality 4.0’. It explores areas where medical device manufacturers should focus investment; the impact on product validation and regulatory and quality compliance; and how Quality Leaders can embed operational quality into risk processes that are outside of traditional QMS. View the whitepaper to explore: Industry 4.0 – What is Industry 4.0 and What is Driving it – The Smart Factory, Cyberphysical Systems, and the Internet of Things – Effect on Products and Processes Implications for the Medical Device Industry – Focus on Digital Technologies – Data Security – Investing in Change Impact on Validation, Regulatory & Quality Compliance – Validating Smart Products – FDA Guidance – Understanding the Quality Impact of the Smart Factory – Embedding Quality in the Value Chain How to Move Toward Smart Quality Management – The Need for Automated, Operational Quality Risk Management – How Quality Leaders Can Gain Organizational Support for Quality 4.0 Initiatives – Quality 4.0 Investments to Support Industry 4.0 – Strategic Objectives Smart Quality Management, Industry 4.0 and Quality Management Systems
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