Jan 7, 2021

The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR 820.181 . If we follow the definition reported in the regulation: Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device. If we move further in the regulation, there is a detailed lists of items that the DMR shall contain: The DMR can be considered as the collection of all the information needed to manufacture the devices. It is acceptable that DMR provides reference to all the documentation covering those specific requirements, rather than physically collecting all the documentation in one place. Device Master Record (DMR) and Design History File (DHR) The design history files (DHR) is rather different from the device master record (DMR). The DHR is the set of documents that demonstrates that the design process of a medical device has been performed according to the design plan and as per applicable regulations. The DHR typically contains, for example, design plan, design review, verification & validation test plan and test reports, design transfer, etc. DMR for Software The device master record shall contain specifications of the device. When the medical device is a software, this means that the DMR shall reference the software requirement specifications as per ISO 62304 . As mentioned before, the DMR shall also contain production process specifications. In case of SAMD, production process is very limited but, for example, it can contain instructions to publish the software on the web or SOP related to location of the binaries and configuration files of the version. Moreover, if the software is delivered in a physical media, the DMR shall contain the labelling information of the specific media. SOP related to maintenance and support process shall be mentioned in the DMR. Typically this includes the problem resolution process and issue escalation process. Moreover, since the device master record shall include documentation related to installation and servicing, all the documentation related to software delivery shall be mentioned in the DMR. This can include, for example, installation instructions, training, support instructions etc. Device Master Record (DMR) and Medical Device File The Medical Device File is a new requirement which has been introduced in the ISO 13485:2016 . There is quite a big overlap between the two documents, but basically we can say that the medical device file requested by the ISO 13485 corresponds to the DMR plus all the design documentation of the medical device (thus the Design History Record). Post navigation 3 compelling reasons to pursue a Bio Services career in medical devices 2020 highlighted the need for Biotech in medical devices and shone a light on potential careers in this field. As the global CoVID-19 pandemic developed and grew over 2020 from the initial focus on traditional medical device development to rapid development and manufacture of PPE and later emphasis on rapid ventilator builds, leading to a deficit in quality assurance and regulatory affairs professionals needed to support the glut of new regulatory approvals required to clear the back log of innovations and registrations in countries clamoring to review and register new emergency products coming on line. Through all of this, continued growth and demand for rapid testing and diagnostics development and therapeutic interventions are required to get lives back to normal. Careers for Biotech in medical device companies abound for engineers and scientists skilled in both traditional science and engineering with development expertise in an ISO 13485 development environment. The incredible pace of the CoVID-19 response has shown that R&D and product development cycles no longer have the luxury of time and creation in silos where science is developed independently and then implemented into a medical device over multi-year programs. Instead they now may need to occur in a condensed, single year cycle. The new path forward is to develop the science and engineer embodiments together in real time. The most efficient way to this is through using professionals who are able to comfortably navigate a product development cycle from both the biological research and engineering of the serviceable device perspectives using what I call a Bio Services perspective. Here is my list of 3  reasons why a Bio Tech professional should consider a career in Bio Services: Bio Services is important work. Mobilizing resources to rapidly respond to the global pandemic is just one example of Biotech in medical device companies. Continued development of technologies and products to monitor, diagnose and treat infectious diseases is a core competency will be a major focus of bio and medtech organizations for years to come. Bio Services will take novel technologies like 3D printing of organs (e.g., skin printing on demand, and organoids on a chip) from lab bench based proof of concept experiments to legitimate organ replacement options in the near future. For example, Regenerative Medicine involves the re-growth or re-generation of damaged body parts or diseased cells requiring therapy only available at the cellular level. As with printing tissues with 3-D printers, this field is still in its infancy however, early successes in clinical trials evaluating relatively simple tissues like cartilage regeneration, are inspiring the promise of future whole organ regeneration making it “a game-changing area of medicine with the potential to fully heal damaged tissues and organs”. Bio Services is very interesting work. The products we are developing are remarkable projects that take cutting edge, breakthrough technologies and turn them into actual medical devices helping improve and extend patient lives in the near term. Some of these projects would have only been considered science fiction a few years ago. Currently our integrated, multi-disciplinary teams of scientists and engineers are working together to support CAR-T (Chimeric Antigen Receptor-T Cell) technologies, microfluidic based lab-on-a-chip diagnostic platforms, organ growing 3D printers and ingestible diagnostic s (Nanobots and Smart Drugs) that can be used to diagnose and treat disease, as it is trackable on its journey throughout the body. There is a lot of work to do. Growth in this field will continue for the foreseeable future. Most certainly there be a heavy demand on pandemic preparedness and product development around meeting the needs in this space. Looking to the future beyond the pandemic, we have been privileged to witness the development and adoption of several remarkable breakthroughs in biological research and development. These include 3D tissue printing, advancements in cell therapy and regenerative medicine and even gene editing. Developing these technologies into commercial products and practical medical devices will be the work of this decade and beyond. I believe that the best way to solve client development problems in these developing areas is by combining a traditional engineering perspective and approach with the knowledge and tools of modern molecular biology, microfluidics and tissue therapies. Building on these areas, exciting opportunities beckon at this engineering/biology interface of Biotech in medical device companies. If the challenges and opportunities I’ve described above sound like work you would love to perform, I recommend StarFish Medical as a great place to work. Our work environment is always evolving as we work on new products and designs, and continue to learn. We are a passionate and dynamic team of ingenious medical device developers. Unique opportunities are plentiful and no two days are the same. At StarFish Medical you will be part of an award-winning, multi-disciplinary development team which prides itself on delivering elegant solutions, exceptional customer service and final products which enable commercial success. Don’t just take my word for it. Check out our video here . Nick Allan is the StarFish Medical Bio Service Manager. He applies creative thinking and innovation to all phases of biotech projects including  product definition  and  sustaining engineering . Don’t underestimate the value of leadership development Employers who question the value of training often ask “What if we train people and they leave?” As a leadership development facilitator and coach, I often respond, “What if you don’t train people and they stay?” I’ve spent literally thousands of dollars investing in my own development, and so it seems a no brainer for potential employees to check out the specific job growth potential as well as the overall growth opportunities offered by the organization they are joining. StarFish Medical is investing in the most robust and intensive corporate leadership program that I’ve been a part of. This program, developed and customized by Calliope Learning in consultation with StarFish, is based on our experience with intensive MBA residential leadership development programs and current research. It flips the training model on its head and provides supporting structures to enable individuals to customize their learning needs and accelerate their leadership growth and potential. Three key features of this mini-MBA like program are exactly what  job seekers interested in job growth potential should be hearing from potential employers about growth opportunities. Individuals choose their learning goals based on their unique and current work challenges. Through a continuous cycle of reading, acting, and reflecting in peer learning groups, they develop learning habits and skills. Many organizations typically develop a set of job competencies and then design training experiences around those competencies. This one size fits all often does not fit all! In this program, individuals identify their learning goals through feedback, support and coaching. The learning goals address their real challenges and are meaningful to them. They then work in peer learning groups as they act on their goals, reflect on their experiences using a journal, and make sense of their experiences through dialogue with their peers. Traditional training program content is replaced by a roadmap about how to learn versus what to learn. Jorge Marques , Manager of Management Reporting & Planning with Powerex , says of his experience with this type of learning model in an MBA leadership program: The design of the program, which combined peer coaching and feedback with personal reflection and journaling, really helped create an environment where we were able to learn as a team. This learner-centered, experiential approach helped us to understand our own leadership styles, as well as to appreciate and learn from the styles of the other learners. Many of us have taken training programs that weren’t relevant and/or not been able to apply what we’ve learned to the job. As a job seeker, ask the organization how they address individual learning needs, support employees to apply their learning to their jobs, and develop their leaders. Collective skills and mindsets are learned through cross-functional teams that work on an important organizational challenge. Peer observation and feedback provide useful vehicles for individuals to develop their skills real-time. A complaint I often hear from the clients with whom I work is that they receive little to no helpful feedback on their performance and sometimes feel like they are operating in silos, disconnected from those who could most help them with their work. They are also looking for more opportunities to develop their leadership potential and contribute to meaningful organizational initiatives. Melissa Anderson , HR Leader with notes about her experience in an MBA leadership program that utilized peer feedback: The peer feedback experience opened my eyes to the fact that no matter what you think you know or how you think you act, others may see it all differently – good or bad. It’s an eye-opening experience, a gift really, for people to share their perceptions of your contributions and behaviours. Going through such a process continues to help me be more resilient, aware and courageous in my leadership journey. When you’re interviewing a potential employer, ask them how they approach not just the performance review process, but how they ensure that people get real-time focused and constructive feedback that allows them to grow. Ask them about the opportunities that are available to learn from others who are in other parts of the organization. Observation, feedback and coaching from an external coach provides a neutral and safe vehicle for exploration and growth. Many organizations are realizing that investing in coaches instead of sending everyone to a generic training program ensures a transfer of learning to the actual job itself. External coaches help individuals tap into their unrealized potential as well as help them surface and address barriers and challenges that would feel too vulnerable to reveal to someone inside the organization. John Douglas , President of of Douglas Group Communications, offers this perspective on the value of external coaching as part of his MBA leadership program: For me, the external coaching was truly transformative and this approach to learning was a game-changer. It made me a much better leader by helping me better understand how team victories could be so much more fulfilling than personal wins. It helped me better understand the positive influence that I could have in a room and it unleashed potential that I did not know I had. While coaching has had a prominent place in the careers of athletes for years, it’s now becoming recognized as an important way to accelerate learning for those in organizations. Ask your potential employer for the type of access you would have to external coaches. Given the increasing complexity and pace of change we are facing in organizations, this type of program offers a powerful opportunity for individuals to accelerate their own growth, while also building the overall capacity of the organization. If I were looking to join an organization and wondering about job  growth potential, I would be excited to see them make this kind of investment in the leadership potential of its employees. Tammy Dewar is a passionate facilitator and coach who integrates theory and practice into meaningful, engaging, and interactive learning experiences. She holds a PhD in adult learning from the University of Calgary, is a Professional Certified Coach through the International Coach Federation, and a certified Workplace Restoration facilitator through the Workplace Fairness Institute. Find out more about her work at www.calliopelearning.com/ The job hunting landscape is always changing and over the past several years it has been increasingly challenging for candidates to find the right company. In response to the pandemic these trends have become more noticeable as we all learn to navigate the new and often remote workplace, see the impact of reduced work forces, and learn about the changing priorities for both the candidates and the employers. As a partner in TallSky Consulting Group with many years of experience in recruiting, I’ve seen some key changes in the past year. Here are 6 important changes for job hunters during COVID: Job Search: Be sure you have a plan, research the companies before applying to be sure you are targeting jobs that really interest you instead of using a mass email approach. You are going to be more successful in finding the right company and position because you are excited about the opportunity. StarFish has an excellent website providing lots of great information about the innovative work they do and also highlighting the strength of their culture and amazing benefits of working there. Diversity: Research shows that diversity leads to improved communication, generates more ideas and challenges people to think outside the box. Gender, ethnic and cultural diversity has also been shown to translate to above average company profitability. StarFish ensures their hiring process provides a structured interview process that eliminates unconscious bias and involves multiple interviewers to assess candidates, resulting in more inclusive hiring practices while embracing the cultural and experiential differences that comes from a more diverse workforce. This brings new skills and experience into the StarFish team and it has never been more important in this competitive world. Quality of candidates: Many industries and companies have experienced a drop in revenue reducing headcounts or required restructuring of their organization and workforce in response. This has resulted in higher unemployment and more individuals searching for work. You may find there are more experienced candidates applying for positions they would not have considered in the past. As a result, you could have increased competition for fewer jobs as employers have an opportunity to hire highly qualified candidates. StarFish is good at recognizing a candidate’s education and unique skills and experience. They work to find the right opportunity in the organization to maximize each employee’s potential, providing them with the ability to contribute and enjoy development and long-term stability in their careers. Interview process: Hiring managers have been used to meeting candidates in person and generally many felt more comfortable assessing a candidate in this format. New public health protocols have increased the use of video conferencing and phone conversations at StarFish in place of the in-person interview. Make sure you brush up on these skills and be prepared to present a professional impression and always be authentic. StarFish provides multiple interview opportunities so you can demonstrate how your experience relates and qualifies you for the specific responsibilities of the position. Mentally prepare and create a safe space for yourself online, listen carefully to voice intonation and read facial expressions to ensure you are providing the right information in response to questions. Try to avoid issues with connectivity and distractions in a home environment by testing systems in advance of the interview. Time frames: Many candidates who have found themselves out of work are eager to get back to work, or they may see the ‘writing on the wall’ with their current employer and desire more secure employment to ensure their financial needs are met, particularly through this uncertain time. StarFish has streamlined their hiring process to minimize unnecessary delays and are focused on keeping strong candidates engaged through multiple interviews to the reference and offer stages to ensure the best candidate accepts the job. Value proposition: Candidates are now searching for positions based on the stability of the company for job security and want good work/life balance, flexible work schedules, as well as health and safety to be a priority. In addition, the company’s culture and core values still hold key importance in attracting the best candidates. A fair and equitable compensation program, learning opportunities, and the potential for career growth are part of this. From the first interview through the offer and onboarding, StarFish consistently delivers on their value proposition to prospective employees. As always, it’s critical for candidates to understand recruitment processes will continue to evolve in the same way jobs and companies must change. Being agile and adapting your skills for job seeking and interviewing will enable job hunters during COVID to succeed in this new and hopefully soon to be post-pandemic world. I would love to learn about your job search and interview experiences, contact me at kerri@tallsky.ca Kerri Keeler’s clients (including StarFish Medical ) appreciate her eye for talent and her ability to find the right candidate to fit the organization and meet the team’s needs. Her HR approach focuses on building diversity and enhancing culture while balancing the objectives of the business and team to deliver results.