INJECTION DEVICE WITH FLEXIBLE DOSE SELECTION

1 . A method of manufacturing an injection device comprising:

a) providing assembly equipment operated with an assembly methodology;

b) using the assembly equipment to assemble a first dose setting mechanism comprising a dose selector operatively connected to other components having a fixed design, where the dose selector is configured to allow only a set of finite predetermined fixed doses to be set by a user of the injection device, where the set of finite predetermined fixed doses includes a lowest fixed dose and one or more higher fixed doses, wherein at least one of the one or more higher fixed doses is equal to the lowest fixed dose plus a fractional amount of the lowest fixed dose;

c) connecting the first dose setting mechanism to a container holding a cartridge containing a medicament for form a complete injection device;

d) evaluating the effectiveness of the set of finite predetermined fixed doses to determine a second set of finite predetermined fixed doses;

e) manufacturing a second dose selector configured to allow only the second set of finite predetermined fixed doses to be set; and

f) using the assembly equipment to assemble a second dose setting mechanism without changing the assembly equipment or assembly methodology, where the second dose setting mechanism comprises the second dose selector operatively connected to the other components without changing the fixed design of the other components.

2 . A method of designing and manufacturing an injection device comprising:

a) providing a first injection device comprising a first dose setting mechanism comprising:

a floating spline;

a dose knob;

a dose selector; and

a snap element,

wherein the floating spline is engaged with a fixed set of splines on the snap element during dose setting,

wherein the floating spline is engaged with a corresponding set of splines on the dose selector during dose setting and dose delivery,

wherein the floating spline is engaged with splines on the dose knob during dose delivery but not during dose setting;

b) using the first injection device in a dose-ranging evaluation comprising:

distributing a plurality of the first injection device each containing a medicament to a plurality of trial patients;

instructing the trial patients to use the first injection devices to perform injections of the medicament using one or more of a set of finite predetermined dose settings associated with the dose selector; and

c) collecting feedback data from the trial patients;

d) analyzing the collected feedback data to determine one or more effective doses of the medicament; and

e) providing a second injection device that has been manufactured with a second dose setting mechanism where the manufacturing comprises:

redesigning the dose selector such that the second injection device can be set to the one or more effective single doses.

3 . The method of claim 2 where the floating spline, the dose knob, and the snap element in the second dose setting mechanism are unchanged in design from that used in the first dose setting mechanism.

4 . The method of claim 2 where the dose selector is the only component in the second injection device that does not have the same design as used in the first injection device.

5 . The method of claim 2 where feedback data comprises trial patient physiological data.

6 . The method of claim 2 where whereby the dose selector is redesigned, manufactured and assembled in the second dose setting mechanism such that only the one or more effective doses can be set by the second dose setting mechanism.

7 . The method of claim 2 where a dose sleeve is manufactured and assembled in the second injection and contains indicia to provide a visual indication of predetermined fixed dose settings that correspond to the one or more effective doses.

8 . The method of claim 5 where the redesigned and manufactured dose selector is assembled into the second dose setting mechanism using identical assembly equipment and methodology as used to assemble the first dose setting mechanism.