Rating: 5/5 - 25 reviews - write a review »
The NP Medical nCompass is the successor to NPatch, an IV catheter designed for ease of use and effectiveness. Inserting a needle into a patient can be a process riddled with too many steps and too many parts. It requires delicate precision and practice for caregivers to ensure that patients... Read more »
Back pain is a common complaint due to osteoarthritis, herniated discs and stenosis. To repair damaged discs and provide relief from pain, surgeons were manually injecting fluids into spinal discs but had no real way to gauge feedback other than patient pain. The procedure was painful, slow and... Read more »
Symmetry asked HaA to develop a standard retractor body with an integrated light source optimized for illuminations of the acetabulum (socket of the hip bone). Requirements included integrating electrical components into the body of the handle, which needed to be comfortable to use, an... Read more »
The SDG is a steerable drill guide for surgical procedures. The overall function of the mechanism was defined as up to standard. It was intended to be a high-volume, single use disposable device. The device had been prototyped and tested in a few different configurations, and the ratcheting... Read more »
Sternotomy is a technique commonly used for open heart surgeries which utilizes a sternal retractor to “crack” open the chest of a patient, granting access to a patient’s heart. The resulting bleeding after opening the chest requires a nurse, tech, or additional physician to constantly vacuum... Read more »
The illumia®lite is a robust, sphere based, hand-held spectral flux analyzer. The analyzer has self-absorption correction that is both reliable and affordable. The illumia lite performs equal or better than the more commonly used bench units. It is the leader of hand held analyzers. Labsphere... Read more »
The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is unique because it is specially designed to complete up to a 5 cm ablation in 6 minutes at max power output using a single applicator.... Read more »
Insulet was about to change the industry with a revolutionary insulin management system. HaA helped that revolution become a reality. The OmniPod is the first tubing-free insulin pumping system. It is discreet, durable, wireless, watertight and incredibly easy to use. The Pod holds and delivers... Read more »
HaA was introduced to Dr. Rosalind Picard and Dr. Reyna L. Kaliouby through the MIT business mentoring program. At that time our team was very active with MIT and Harvard. After our first meeting with Rosalind, and Dave Berman, HaA listened and understood the importance of their product, with... Read more »
Allurion worked with the HaA team to help develop its revolutionary swallowable gastric balloon device. The Allurion Balloon is a pill balloon capsule, which is swallowed under the guidance of Healthcare Professionals without anesthesia or endoscopy. It is a safe, non-permanent device that is... Read more »
Verb Surgical is a digital surgery platform that combines robotics, advanced visualization, cutting-edge instrumentation and data analytics. The HaA team has a long history with robotic surgery from our initial beginnings working with Rogers Surgical, founded in 1999, which eventually became da... Read more »
Perma Pure is a leading manufacturer of gas conditioning products. When Perma Pure asked HaA to take on the design and development of the O2asis, they knew there would be challenges ahead. These would include the testing involved with a respiratory device involving rigorous biocompatibility and... Read more »
The AngioVac Generation 4 Cannula is a single-use, venovenous cannula with a nitinol basket, reinforced, self-expandable funnel shaped distal tip used during extracorporeal bypass for the removal of undesirable intravascular material such as thrombi. The AngioVac Cannula is used in conjunction... Read more »
Prior to HaA and after eight years and millions of dollars invested in research with MD Andersons, Radiadyne worked closely with HaA to develop an advanced fiber optic dosimeter. OARtrac is the first of its kind radiation dose monitoring platform providing gold standard accuracy without... Read more »
The Boston Scientific eXcelon Transbronchial aspiration needle is a minimally invasive procedure used to collect tissue for the diagnosis and staging of lung cancer. It is a safe, economical device with a low incidence of complication and lowers the need for invasive surgical procedures and also... Read more »
Phase 1: Planning The first stage of the medical device development process involves meticulous planning. During this phase, the project team identifies the scope, objectives, and requirements of the medical device. We establish a clear roadmap, define the project's goals, allocate resources,... Read more »
As an ISO 13485 certified company ourselves, we know the standard inside and out - it guides everything we do. Our dedicated quality team is involved from the very first step of development to ensure compliance, whether it's a Class I or Class III medical device. We create tailored eQMS's for... Read more »
With 3d prototype capabilities in-house, we deliver rapid prototypes for continuous feedback. We are communicative, providing prototype models directly to our customers, and bringing presentations to life. With this approach, we can quickly iterate design changes with the confidence that... Read more »
Regulatory compliance is our primary company objective. Our team, including a former FDA reviewer, has led our customers to regulatory compliance in both US and EU markets. With a focus on 510k submissions, we have a streamlined process of creating and approving required documentation from... Read more »
HaA's Risk Management process is embedded right in with our eQMS, seamlessly integrating all risk activities and documentation with regulatory documentation. Our company follows a usability-centered approach to product design, meaning that potential risks are considered at project start and not... Read more »
HaA Product Development manages safety testing through our qualified partners. Read more »
HaA starts by listening and documenting the needs of the customer and product. From there we enter into a planning phase, which includes a product requirements document. HaA plans and schedules the entire project from start to finish including all testing, risk management and manufacturing... Read more »
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