Very interesting and relevant lecture by Ian Hewitt entitled “Design for Medical and Well Being”

Ian discussed one of the most important considerations when designing medical products which is standards and classifications which are determined by Implant, intrusive and data recording.

There are 3 classes:

Class 1

• Low risk .. e.g. walking stick, wheel chair

Class 2

• Stringent Regulations
• Record data, Limited diagnosis
• E.g. Syringe, gloves, pregnancy Kit- self diagnostic

Class 3

• Highest category
• High Risk- complex devices
• Pace Maker, Ocular tweezers, Insulin Pen, Cannula.

Considerations:

• British Standards
• If it has a battery – needs to be able to be accessed later for recycling

Cleaning

• Surface finish
• Limitations
• How easy

Maintenance

• Is it externally serviced
• Parts
• Screws- easily accessible
• Parts based- disposable

Reuse

• Sterilised
• Collected
• Stored
• Re- distributed

Consider

• NHS may not likely adopt your project just due to the system , pricing range, competitors …  “disruptive innovation”
• Labels
• Colours

Data recording

• Legality with holding data
• Has to be stored in a certain way

Diagnosis

• Safety
• Delivery of Information

Sharps

• Disposal
• Storage
• Contamination
• Replaceable

Materials

• Paint
• Material type (Allergies)
• Finishes

End User

• Age groups
• Different user perspectives

Consider constructing DARL and CRL logs as method for development

An incredibly relevant and useful lecture and I have discussed to have a meeting with Ian in the upcoming weeks to gain his thoughts and views on the project.