HSD recently shared an article posted on MDDI discussing the “Chicken and Egg” Problem in developing product requirement documents for fist of kind products. The article goes into detail on the importance of understanding the value proposition of new products by utilizing the lean start up methodology and the FDA waterfall.
Posts Tagged ‘design firm’
Best of luck to Mike Quinn, our Director of Mechanical Engineering who is going for the Ironman this Saturday!
Join HSD at the 2015 IDSA Medical Conference where Tor Alden of HSD will discuss his experiences and discovery challenges regarding the front end development of first of a kind medical products and how there is a need for increased collaboration in the design of complex systems in the medical and lifescience device development. The ability to capture user needs and balance them with technical requirements runs concurrently with the development of the requirement documents. For more information on the conference go to the IDSA Medical conference.
HS Design has teamed up with BioTrak Health to develop the Halo™ body worn device that helps eliminate chronic tension headaches, migraines and TMJ without the use of drugs. It integrates with smartphones to personalize biofeedback therapy in the comfort of your own home. The haptic feedback allows users to realize when they have excessive tension, provides monitoring and coaches users through relaxation training exercises. Check out halocalm.com for more information and pre-ordernig.
EMIT HypothermX™ HX100 intravenous Blood & Fluid Warmer is a patent protected portable fluid warming device designed to warm intravenous fluids, blood or blood products infused into a patient to prevent or treat trauma, environmental, procedure related and/or induced hypothermia. Heating is accomplished via a flameless hydrocarbon combustion process fueled with a isobutane/propane mixture.
HypothermX™ HX100 is the first truly light weight (< 3.0 lbs), portable, long-term (>4 hours continuous use) solution to offer actual therapeutic warming in the field for injured patients. HypothermX™ HX100 is capable of warming up to 5 liters of saline introduced at 15° C and 15 units of packed red blood cells introduced at 5° C to 38° C ± 3° C with an infusion rate between 50 ml/min and 200 ml/min and ambient conditions between 0° C and 40° C. The system has numerous safety features and provides the user with the ability to temporarily silence alarms based on operational needs.
Congratulations Malvern. Malvern Instruments Ltd. expands with the recently acquired GE Healthcare Life Sciences company’s MicroCal microcalorimetry business. Its great to see products getting through to production close to their original concept!
The Isothermal titration microcalorimetry (ITC) is a very important tool in drug discovery as well as for the regulation and study of protein interaction. MicroCal ITC systems determine the heat released or absorbed directly during a biomolecular binding event. This helps obtain a label-free direct measurement of binding affinity and thermodynamics in one experiment. Comprehensive information is offered for studying a wide range of biomolecular interactions.
Click here to check out the video!
HS Design received BSI recertification for operating QMS that complies with ISO 9001:2008 & ISO 13485:2003.Friday, May 1st, 2015
HS Design, Inc. is excited to announce it has received recertification from BSI for operating a Quality Management System which complies with ISO 9001:2008 and ISO 13485:2003.
The recertification verifies that HSD continues to effectively implement all requirements of FM 586115 (ISO 9001:2008): Design and development of industrial and consumer products and FM 582846 (ISO 13485:2003): Design and development of medical devices.
These internationally-recognized certifications are used by service and manufacturing organizations to create a standardized Quality Management System (QMS), which is continuously evaluated to ensure that it conforms to the principles of quality improvement and customer satisfaction.
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.
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.
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.