2.0 Problem Formulation

Medical Devices

Problem Statement: Be able to develop a small robot to quickly and effectively suture in tight spaces, minimizing the amount of space needed and reducing time needed to finish surgery.

 For example, a big issue that is prevalent is the functionality of prosthetic hands for amputees. Or it may be possible to develop more automated surgical devices, like robots that suture without the assistance of a doctor. 

STATEMENT-RESTATEMENT

• Restated Problem: Be able to develop or improve surgical equipment that can deal with more accurate surgeries.

• Real Problem: Suturing can be difficult for doctors in certain areas of the body, where human hands can struggle to maneuver, requiring more space to suture.

ACTUAL CONSTRAINTS vs GIVEN OR INFERRED BOUNDARIES

• Actual Constraints: We have to consider the medical regulations on equipment/technology. As well as the financial and technological limitations at this point in time.

• Given/Inferred Boundaries: We must consider the size and portability of the equipment. The longevity of the equipment in terms of maintenance and material cost. 

MEANINGFUL GOALS vs GIVEN OR INFERRED GOALS

• Meaningful Goal: Have the equipment make the medical process of suturing easier, efficient, and safer. 

• Given or Inferred Goal: Automate medical procedures and provide a quality experience

INPUTS, OUTPUTS, AND UNKNOWNS

• Inputs: Expert feedback, technological expertise, financial investments, and data

• Outputs: Create an automated process for procedures and surgeries

• Unknowns: Actual efficiency of the surgical/medical equipment, willingness to use the equipment and its implementation

3. Revision Method

   Problem Statement: It can be difficult for surgeons to accurately and quickly suture during surgery

   Revised Problem: Surgeons could benefit from a robotic device that can help suture very small wounds that a surgeon would struggle to do.

4. Present State-Desired State (PS-DS) Strategy:

   Present State: Suture and surgery robots are very big and clunky. While they are precise, they take up a lot of space and are difficult to move around. 

   Desired State: Develop as portable a device that it can suture individuals quickly, safely, and efficiently whenever they need it. 

Kepner-Tregoe (KT) Situation Analysis: 

What is known:

• Sutures are needed for nearly every surgical procedure

• Surgeons need to completely close wounds, even if they are in tight spaces

• Sutures need to be tight, and the wound must not open easily

• Sutures must be accurate to minimize patient impact and the time needed to heal

Tasks to be performed:

1. Identify the least successful sutures carried out at the moment 

2. Research existing autonomous solutions for suturing

3. Develop a device capable of conducting a wide variety of sutures

4. Formulate a means for said device to fit in reduced spaces

5. Develop a prototype of this machinery 

6. Conduct functional testing and trials on fake wounds in controlled environments 

Kepner-Tregoe (KT) Problem Analysis:

What?

• Suturing is an important part of nearly all surgeries, and often the sutures are needed in small or hard-to-reach places. A device could greatly help with suturing in these areas. A technique must be developed to achieve pin-point accuracy while being very quick.

When?

• Suturing has been a difficulty for surgeons ever since surgery became commonplace.

Who?

• Surgeons and their assistants would greatly benefit from a device that could quickly and accurately suture wounds in small or tight places.

Where?

• The device would be used by and be distributed to hospitals and specialty doctors/surgeons. 

Why?

• Quick and accurate suturing can help decrease the time needed for surgery, which can help if the surgery is urgent or time sensitive. It can also help decrease cost for the patient.

How?

• The surgeon or an assistant would use the robot to make a suture in a tight or hard-to-reach area.

Kepner-Tregoe (KT) Decision Analysis:

Alternatives Generation

Alternative A: Develop a new type of minimally invasive robotic surgical system designed specifically for complex suturing tasks.

Alternative B: Enhance existing surgical tools with better ergonomics and precision for manual suturing.

Alternative C: Create a hybrid system combining manual dexterity with robotic precision.

Alternative D: Develop advanced suturing materials or techniques that can be applied more easily in tight spaces.

Alternative E: Invest in virtual reality (VR) or augmented reality (AR) technologies for training surgeons on difficult suturing techniques.

4. Evaluation of Alternatives

Effectiveness:

A: High (robotic systems can perform precise movements in tight spaces).

B: Medium (improvements may help but won't fully address maneuverability in tight spaces).

C: High (combines the benefits of manual and robotic systems).

D: Medium (addresses the issue indirectly by simplifying the suturing process).

E: Low (improves skills but does not directly address the physical limitations).

Usability:

A: Medium (requires training but can be highly intuitive once learned).

B: High (familiar form factor and function).

C: High (benefits from familiar manual techniques while adding robotic precision).

D: High (does not change the fundamental approach to suturing).

E: Medium (useful for training but doesn't change in-operation use).

Safety:

A: High (robotic systems can reduce human error).

B: Medium (improvements may reduce some risks but not others).

C: High (reduces human error while maintaining surgeon control).

D: Medium (new materials or techniques may have unforexseen risks).

E: High (improves skill without introducing new risks).

Cost-effectiveness:

A: Low (high development and implementation costs).

B: High (improvements to existing tools are typically less costly).

C: Medium (costs more than manual tools but less than full robotic systems).

D: Medium (depends on the nature of the materials or techniques).

E: Medium (initial investment in technology, but reusable for multiple training sessions).

Compatibility:

A: Medium (may require new infrastructure or integration).

B: High (enhancements to existing tools).

C: High (builds on existing practices).

D: High (does not require significant changes to existing equipment).

E: Medium (requires additional technology not currently used in surgeries).

Training and Support:

A: Medium (requires comprehensive training programs).

B: High (minimal additional training required).

C: Medium (some new training required but builds on existing knowledge).

D: Medium (may require new technique training).

E: High (focus is specifically on improving surgeon training).

Optimal Decision

Based on the evaluation, Alternative C: Creating a hybrid system combining manual dexterity with robotic precision seems to be the best option, balancing effectiveness, usability, safety, and compatibility. It addresses the core issue of maneuverability in tight spaces while leveraging the familiarity and skills of surgeons, providing a practical and innovative solution to the problem of difficult suturing areas. This option seems to offer the best balance of improving surgical outcomes without introducing excessive costs or requiring significant changes to current surgical practices.