16 Most Important Traits and Skills to Medical Device Development  

Our most read new blog of 2024 was a group effort. The traits and skills most important to their medical device development work were interesting and surprisingly soft.

Interested in working with (or in) a team that values these skills and traits? 

Contact us or check out our career page. 

Choosing a Drug Delivery System Imaging Technology

Accurate and precise delivery of pharmaceuticals or therapies often depends on real-time imaging systems. These drug delivery system imaging techniques enhance both accuracy and precision; however, the choice of imaging method and required equipment introduces constraints that affect the design, form, and function of drug delivery systems. Author: Joris van der Heijden is Bio Services Program Manager at StarFish Medical. 

Developing Class C Firmware for Medical Devices

IEC 62304 standardizes the Software Life Cycle Processes for Medical Device Software providing a common framework for software development and maintenance processes and activities. Written as a process standard, it tells what to do, but not how to do it. When it comes to designing Class C firmware for medical devices, having a clean and clear Software Architecture is key. Specifically, when Software Item segregation is required, an architecture like the one discussed above, combined with the blackboard approach, will structure the development process efficiently and allow for clear demonstration of the effectiveness of segregation. Author: Bertram Hildebrand is a Senior Firmware Architect at StarFish Medical.

21 Interview Questions that Work (and Why)

It’s always job-hunting season! This team article shares favorite interview questions and techniques (with the reasoning behind them) that employees have used or encountered for a variety of roles in medical device development. An interesting mix of classics and new twists, we hope they inspire future interviews and insights into StarFish culture. Author: Astero StarFish is the attributed author of StarFish Medical team blogs.  

Medical Device Innovation Initiatives

We design medical devices and embrace the energy and shared passion that comes when our team members get to work together in person as part of our medical device innovation initiatives. Technology and Covid brought about a large shift in the workplace, with many companies embracing remote work. We’re looking at ways to help make the office a more attractive place to work for a full return to working in our Toronto and Victoria offices. This article examines several initiatives from our People and Culture team to make the most out of employees’ time back in the office. Author: Jess Hickman is the StarFish Medical Senior People & Culture Manager.

Canadian Medtech Entrepreneurs: Reduce your Medical Device R&D costs by 50%

Drawing from Canadian Revenue Agency’s Guidelines on the SR&ED Investment Tax Credits Policy, this article provides an overview of the Canadian SR&ED program and a 5 step high-level guide on how to prepare an SR&ED tax form (or T661).  An important part of Canada’s economic engine since 1944, the SR&ED tax incentive is the government’s largest single support program for R&D. Annually, this program provides over $3B to over 20,000 companies in Canada making it one of the more generous R&D programs among Organization for Economic Cooperations and Development (OECD) countries. Author: Nick Allan is the Bio Services Manager at StarFish Medical. 

5 Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenges

Cell and Gene Therapies (CGT) are revolutionizing modern medicine by offering potential cures for previously untreatable diseases. However, the effective delivery of these advanced therapies poses unique challenges. This article explores five key challenges associated with CGT products that need to be considered for effective treatment and discusses how innovative Drug Delivery Devices for Cell and Gene Therapies can address these issues. By addressing issues such as targeted delivery to hard-to-reach locations, handling of high-viscosity formulations, sensitivity to shearing, removal of cryoprotectants, and removing the need for complex infrastructure, these devices are critical in enabling the full potential of CGT products for patients. Author: Gary Skarja is a Bio Services Program Manager at StarFish Medical.

Medical Device Post-Market Surveillance Enhances Safety

In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the post-market phase, where vigilant surveillance becomes paramount. This article delves into the significance of medical device post-market surveillance (PMS), exploring its importance, challenges, and potential improvements. By addressing challenges, embracing innovations, fostering collaboration, and involving patients, we can collectively enhance the post-market surveillance landscape and contribute to a healthcare system that prioritizes patient well-being throughout the entire lifecycle of medical devices. Author: Palash Jha is a QA/RA Specialist at StarFish Medical with a strong background in biomedical engineering. 

Six Project Manager Skills for Success in the Medical Device Industry

From diagnostic tools and surgical instruments to advanced imaging systems and wearable health technologies, medical devices play a crucial role in patient health. It’s a unique field that directly touches human lives. A Project Manager navigating this complex landscape requires the ability to marry traditional Project Management Skills with the specificity of medical device industry practices that focus on patient outcomes and regulatory requirements.  Whether you are an aspiring PM or looking to enhance your existing skills, focusing on the six areas described in this article will help you excel in a challenging yet rewarding field. Author: Shalaka Maind is a Project Manager at StarFish Medical with M.S degree in Biomedical Engineering.

14 Ways to Increase Medical Device Speed to Market

For this final top 10 article, our employee experts drew upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality. Read on to discover how understanding the intended market, focusing the development process, and paying early attention to regulatory requirements and design transfer can speed your medical device commercialization journey. Author: Astero StarFish is the attributed author of StarFish Medical team blogs.  

How to identify a Conformité Européenne mark vs a China Export mark

Learn how to identify a Conformité Européenne mark vs a China Export mark including information on meanings, regulations and visual layout of the two marks. Being able to spot the difference between the two marks doesn’t quite save you from counterfeits, as there are vendors who place fake UL, CE, and other markings on their products. Constant vigilance on the part of engineers and supply chain management is needed to ensure you’re using genuine parts.  Author: Ashwin Sira is a former StarFish Medical Junior Electrical Engineer.

Pros and cons of two popular Ultrasound signal processing techniques

Prior to constructing ultrasound images out of raw radio-frequency (RF) data, the transducer pulse frequency must be removed from the data to prevent ripple artifacts in the image. There are a number of methods of demodulation in ultrasound. This blog discusses pros and cons of the two ultrasound signal processing techniques used predominately nowadays. Author: Kenneth MacCallum, PEng, is a former Principal Engineering Physicist at Starfish Medical.

How to Perform Medical Device Drop Test

Medical Device Drop Test and Push Test are part of IEC 60601-1. This blog describes two of the most common mechanical tests that medical device designers may want to perform in-house before sending a device for third party testing. Author: Nigel Syrotuck is a StarFish Medical Project Engineer.

Using Smartphones as a Medical Device for Point-of-Care Applications

8 Reasons to use smartphones for medical device Point-of-Care applications with real examples and tips for developing a smartphone device. Smartphones as a medical device will play a major role in the way healthcare providers handle diagnostics, monitoring and provision of the diagnosis at the point-of-care. Author: Lorenzo Gutierrez is a former StarFish Medical Microfluidics Manager.

RoHS 2 vs RoHS 3 impact on medical devices

RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Discover if your device is RoHS 3 compliant. RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated on March 2, 2021 to include more details on the July 22, 2021 deadline. Author: Nigel Syrotuck is a StarFish Medical Project Engineer.

Understanding the UOUP (User Interface of Unknown Provenance) section of IEC 62366 -1:2015

Comparison of the biggest unknown between IEC 62366:2007 and IEC 62366 -1:2015– Fig. 5.10 User Interface of Unknown Provenance (UOUP). From a regulatory standpoint the differences between IEC 62366:2007 and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Probably a good thing from a usability document, I guess! The biggest unknown was Fig. 5.10 User Interface of Unknown Provenance (UOUP). Author: Niall Redmond is a former StarFish Medical Industrial Designer.

Qualifying and Managing RoHS and REACH suppliers

Overview of RoHS and REACH and vendor compliance required to sell equipment or consumer parts that use hazardous materials in the EU, China, Korea and some parts of the United States and Canada.  Learn how to know which vendors possess compliance. Author: Taimoor Khan is a Program Strategy Engineer at StarFish Medical.

Sweet Relief – How to avoid hole distortion in sheet metal parts

Sheet metal fabrication is an excellent method of making mechanical parts, especially support brackets. They tend to be cheap, light, strong, and easy to pack and ship. This article explains how to avoid hole distortion in sheet metal parts. Author: Nigel Syrotuck is a StarFish Medical Project Engineer.

Overview of Optical Technologies for Point of Care Medical Devices

Creating an insulation diagram early, referencing it in your system architecture document, and updating it during development will reduce the chance that a design change compromises patient safety. This article includes a simple example of a situation that is best identified early and planned for, as opposed to making a late fix that negatively impacts the design. Author: Christian Proch-McMechan is Principal Electronics Engineer at StarFish Medical.

Three Considerations for Water Ingress in Medical Devices

Navigating water ingress in medical devices can be tricky, as one of the key requirements for ISO 60601-1 is the protection against ingress.  With so much development focused on the functioning of the medical device, ingress protection can be overlooked or left late in the development phase as something that is easily solvable. This blog covers 3 areas of concern:

1. Cleanability – needlessly high IP requirements can have unintended consequences
2. Orientation – understand which way is up
3. Heat dissipation – understand your heat dissipation requirements

Author: Dana Trousil is Mechanical Engineer Team Manager at StarFish Medical.