Inventors: Faith C. David-Hegerich, Holliston, MA (US); Nathan Rollins, Boylston, MA (US); Paul Bertram, Franklin, MA (US); Robert C. Uschold, Leominster, MA (US); William J. Kane, Sutton, MA (US); Thomas Doucette, Stow, MA (US); Timothy N. Johnson, Exeter, NH (US); Michael Denzer, Ringoes, NJ (US) Correspondence Address:

[0007] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustra tive, not limiting in scope.

[0036] FIG.l6 is side view of the device ofFIGS.l-4 with the handle at its lowest position relative to the needle guard and plunger, at the point where the expelling of the medica ment in the syringe is complete.

First, it provides an ergonomic, easy-to-use device that is particularly suitable for self administration of injections by patients with dexterity limitations, including the elderly and persons suf fering from arthritis in the hands or fingers.

To do so, the track follower will contact and move past the rib 50, making an audible click noise to signal to the user that the injection of medicament is substantially complete.

In conclusion, a large body of published evidence accumulated over the past two decades testifies to the patient-related benefits of the NovoPen® family of insulin injection devices in the treatment of diabetes.

Pen devices, like NovoPen®, simplify insulin administration, making the injection procedure easier and quicker[3-6] and dosing more accurate;[7-9] other advantages include reliability, durability, convenience, discretion and improved flexibility.

The authors identified and selected English language publications of studies (excluding review articles and comments) of NovoPen® devices in the diabetes/insulin therapy area according to whether they contained evidence of the effects of these devices in any of the following categories:  efficacy (metabolic control), accuracy and dependability;  safety (either in terms of hypoglycaemic episodes or needle disposal);  ease and convenience of use;  patient preference and acceptability;  social acceptability;  lifestyle flexibility;  pain and discomfort;  fear of injections;  quality of life (QOL);  compliance.

Experience With the Novopen Family of Insulin Injection Devices (printer-friendly) Page 8 of 66 the pen injector regimen (p < 0.08); the subgroups with higher trait anxiety scores experienced significantly better self-concept in relation to having diabetes vs syringe (p < 0.05).

The major advantage of NovoPen® was flexibility in timing and size of meals; inj with NovoPen® were reported to be less painful than conventional Jenkins et al.[38] Eight adolescent (aged 12 15y) pts with diabetes (type unspecified) of mean duration 5y

the-art Hudson humidifiers and Siemens ventilators • Directed Engineering design efforts for an Insulin Pump start-up company - Bionica, Inc. • Optimized a patented venting method for sterilized laryngeal mask products.

Traveled to 20+ major cities & 50+ Hospitals in the US and Europe to interface directly to Doctors, Clinicians, Nurses, as well as Regulatory Agencies to gather critical drug delivery knowledge to be used in a Quality Function Deployment effort.

CHARLES E. CLEMENS resume • Initiated & directed a competitive technical benchmarking effort of US & European drug delivery systems which provided the foundation for the marketing strategy as well as the fundamental measuring parameters for the design team.

Helped train the technical team with new skills in the area of Quality Function Deployment (QFD), DFMA, Design of Experiments (DOE), and the Performance Excellence (PE) process.

Lead the development of a new mono-leaflet implantable heart valve • Invented and directed the proprietary design of an accurate rotary dry chemical delivery system to feed zirconium oxide granules to a fluidized bed coating process.

Mylan's Upgraded EpiPen Torn Apart By Experts Dr. Julie C. Brown, a University of Washington School of Medicine pediatric emergency physician, holding two EpiPens, the new design at left and the old at right.James Cheng / for NBC News So, as Congress has been trying to figure out the company's business model, a medical technologies expert and a doctor have been physically taking apart Mylan's famed auto-injectors to find out exactly how — and where — that money was spent.

After a Seattle doctor cut open EpiPens from before and after Mylan's upgrades, NBC News sent versions of the epinephrine auto-injectors to a medical technology consulting firm.

In her sworn testimony before the House Committee on Oversight and Government Reform last week, Mylan's CEO said most of the money the company had spent on EpiPens went towards marketing and lobbying.

Senator Chuck Grassley, an Iowa Republican, sent a letter in August to Bresch requesting more information about how changes to the EpiPen had caused Mylan to increase the price.

In response to a request for comment on this story, Grassley said in an emailed statement to NBC News: "The company cited product improvements as reason for justifying the cost increases.