What is a Penetration Test? Free-form security testing, or penetration testing (often called pen testing), is a minimally structured examination of the cybersecurity for a target device or system. For those familiar with requirements-based verification and validation (V&V) testing, penetration testing is different altogether. The intent of penetration testing is to find unknown security vulnerabilities […]
Medical Technology International Business Opportunities
February 8, 2022 by
Trade Mission to the UK and Finland In November 2021, I had the honor to represent the MDRG and the state of Minnesota on the Governor’s Trade Mission to the UK and Finland. Our mission of 70 was comprised of four tracks: Medical Technology, Environmental Technology, Food and Agriculture, and Education. MedTech Track The Medical […]
Consider Cybersecurity Early When Developing Your Medical Device Design
January 24, 2022 by
Three Important Questions to Ask: Will this Medical Device be connected to a network? How would a breach of this Medical Device affect patient safety along with corporate negative publicity? What role will labeling play in the overall security of this Medical Device? The answers to these questions should be well-thought out, reviewed, and have […]
COVID’S impact on connected health – developing your value strategy
March 10, 2021 by
Connectivity Enables a Continuum of Value – from the device to holistic, patient-centric services. COVID-19 has changed our world in many ways. The medical device industry has been changing as well. The urgency and direction of most of the changes we see coming to medical devices were already in motion before COVID. Now, connectivity is […]
UK Conformity Assessment (UKCA) marking comes into effect
February 5, 2021 by
Following the end of the Brexit transition period, the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will not be transposed into law in Great Britain. In this context, it is important to be aware of the distinction between Great Britain – England, Scotland and Wales – and the United Kingdom, which comprises Great […]
Changes in the European Medical Devices Regulations now require traceability of Medical Devices
October 9, 2020 by
Historically, companies selling implantable medical devices in Europe have not been required to provide patients with device-specific information. In the event of a medical emergency, not having immediate access to this critical information predisposes the patient to a variety of unnecessary operational risks.That changed with the European Medical Devices Regulation (MDR) modifications approved by European […]
Why the R&D Group Need Not Fear the Package and Distribution Lab When Developing an Injectable Biologic Product
July 15, 2019 by
A recent FDA Guidance document titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” outlines recommendations on the design and evaluation of comparative analytical studies intended to support a therapeutic protein product. This includes conducting an appropriate physicochemical and functional comparison of the stability profile of the proposed product, accelerated and stress stability […]
Understanding the biological effects of medical packaging in the assessment of a medical device.
June 17, 2019 by
For many years Toxikon has been performing biocompatibility testing of medical devices. Biocompatibility testing is a risk/benefit approach in understanding the safety of a medical device or product. That process can be pretty simple, using the guidance of ISO 10993 and regulatory guidance for industry. Resources like ISO 10993-1 and the FDA’s guidance available today […]
New Year, New Budget
January 15, 2019 by
Happy New Year medical device industry! The good news for medical device manufacturers in 2019 is that the medical device excise tax still does not apply with the current moratorium through December. Meanwhile, manufacturers can continue planning for the foreboded tax but also allocate those dollars towards R&D and new product, design, build, test and […]