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. 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 […]
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 […]
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, […]
Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.
Biological sciences medical device breakthroughs for this decade have a solid base to build upon. 3D tissue printing, advancements in cell therapy and regenerative medicine and gene editing breakthroughs were developed and adopted in the last decade. Developing these technologies into commercial products and practical medical devices will be the work of the 2020 decade. […]
The internet is full of great research data. This blog shows how to research four questions one should address when considering Infectious Disease Diagnostics market potential by using public information. I explain how publicly posted research and reports can help analyse and build answers for activities like developing a new PoC Assay.
Negotiating low volume lead supplier times is not without challenges. Vendors can look at low volume quantities or lower dollar value orders as less priority or of importance to fulfill. Adding to this challenge, Just In Time (JIT) delivery is often used to meet on demand client sales orders. The pre-planned anticipated lead time in […]
Supply chain quality challenges in low volume manufacturing for medical device manufacturers include analysis of the data measuring supplier performance in relation to product risk. Under ISO 13485:2016, section 7.4, purchasing has a higher profile and more stringent requirements for documented purchasing process and supplier management.
Manufacturing low volume, high complex medical device products requires sourcing highly customized and expensive parts. This makes it hard to extract good value from your medical device supply chain. While high-volume production enables economies of scale, low volume custom-made production involves fewer parts to absorb product development, tooling and production equipment costs.
Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market. Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an […]
Keep your project on time, within budget Testing medical devices in a Biolab often requires changing locations from an engineering lab to a Biosecurity Level 2 (BSL2) BioLab that can facilitate specialized tests involving potentially dangerous microorganisms, tissues and biological fluids. Careful pre-planning is required for timely experiments to take place in BSL2 BioLabs. Poorly […]
Leveling the Playing Field with recent Draft Guidance Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March 29, […]