March 20th, 2015
Smart networked medical devices are on the rise, therefore demanding increased cybersecurity and closer adherence to modern cybersecurity regulatory guidelines. This white paper focuses on:
- Security in the era of smart networked medical devices
- Designing medical devices with a multidisciplinary team
- Examples of proactive security activities
- Security steps for a device’s life-cycle
- Main types of exploits and how to prevent attacks
Download our latest white paper on Cybersecurity in Medical Devices here.
January 29th, 2015
HSD is excited to celebrate its participation in New York’s growing pharmaceutical, biotech, medical technology and LifeScience industry by supporting MedTech. HSD is part of over 100 member organizations across New York State offering expert advice and services. HSD has long collaborated and assisted leading start-ups, Universities, and businesses in developing and commercializing medical research programs. For more information regarding MedTech, click here.
January 13th, 2015
HSD assisted in developing a disposable suturing tool initiated by a grant from TEDCO to transfer and commercialize technology. Designed to be an inexpensive, disposable suturing tool that places sutures at regular intervals by means of a suturing guide. To place a stitch with this device, a surgeon simply places the fascia layer between the two arms of the device and squeezes the trigger. The device also protects the needle from accidentally puncturing the internal organs without the assistance of other currently used protective equipment. HSD designed, engineered and prototyped multiple concepts leading to a final working proof of concept for use in pre-clinical trials.
January 3rd, 2015
Check out the new PrimeraDx Software. HSD is proud to see the Modaplex software GUI integrated into the Qiagen Modaplex system designed to automatically run the instrument. Easy to use plate map creation using touch screen s sets up the PCR reactions for simple runs. The software takes it from there! The graphical user interface design is geared for simple user set up and sample runs of complex single well reactions.
The Modaplex System is an automated, high throughput and high multiplex real-time PCR and capillary electrophoresis instrument. The system is capable of running up to 48 samples and reporting on up to 60 targets per sample in 3.5 hours. Both instrument and GUI were concurrently designed to reduce the complexity for clinical researchers.
December 2nd, 2014
Whether you use an iPhone, iPad or Camera, Canfield now has the solution. The Nikon 1 Camera kit turns any VEOS HD dermatoscope into a high resolution digital capture system. A simple magnetic attachment system allows secure connection in seconds, so the camera is ready when you are. With the brilliant 3” LCD display you have a crisp, clear view of the lesion from any angle and a preview of the photograph immediately after capture. Combining the VEOS’ unequaled dermoscopy with the Nikon’s CMOS sensor and fast, accurate “Point and Shoot” technology, you can be sure of a razor sharp, perfectly exposed, clinical quality image every time.
November 10th, 2014
HSD has adopted JAMA Requirements Management Software for increased robustness in Design History Files, Traceability and collaboration. “The addition of this software allows our group to more easily conform to our design process based on ISO 13485″, said Bob Barry, Director of Engineering. He adds, “by embracing an open, collaborative approach to product delivery, we avoid work arounds in our process and eliminates the communication obstacles responsible for product delays”. Seymour Friedel, CTO of HSD, illustrated “the integration it brings across all disciplines, Hardware, Software, and System design helps bring the product faster with increased requirements traceability”. To learn more about JAMA click here.
October 27th, 2014
QMS Relevant Certifications:
- ISO 13485:2003 Medical Design Certification
- ISO 9001:2008 Industrial and Consumer Product Certification
- AAMI Human Factors Committee Member (creators of HE75 & ISO 62336)
HSD is proud to be recognized as a Qmed quality supplier of medical product design & development. As an Experienced medical product design firm, we can rapidly bring your product idea to market while mitigating risks.
October 20th, 2014
Another great article on the every changing landscape of the medical device industry from Core77; Designing for the Medical Device Industry: The Future - Connected
HSD, Dassault Systems and Ximedica continue their insight on the changing landscape of the medical device industry, technology and the ACA.
October 13th, 2014
Angelini announces a breakthrough in device sanitization – ALUVIS the device that sanitizes all mobile hand-held devices. It’s simple and easy to use. HSD assisted in the design, engineering and pre-production prototyping of this revolutionary device that utilizes UV light to reduce microbial contamination on mobil hand held devices. Check out out animation of the Aluvis™ UV Sanitizing system here.
October 13th, 2014
Check out the article on Core77; Designing for the medical Device Industry: Holistic Solutions - A multi-Faceted Approach
HSD, Dassault Systems and Ximedica discuss the challenges of designing complex products in a regulatory environment and moving through the sea of verification and validation.