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We are not sure of BN3101's requirements , how can we get help?

It is important for you to have the basic domain knowledge related to the clinical problem to be solved. The reading assignments, lectures and demonstrations will give you the necessary background to proceed with your design project. 
In addition to the lectures, as the module progresses you will:
  1. Have a chance to talk to surgeons who will be doing rotator cuff repair surgery 
  2. Be assigned a mentor who will answer any technical questions that you have 
  3. As a team you all will have one or two feed back sessions from me 
  4. Be provided with a sample design history file after the basic lectures  

What do we do with the lab book at the end of the term?

Each group will have to hand in the notebook at the end of term as it will constitute part of the assessment for your project. The notebook will be retained by the Div of Bioengineering. You are of course welcome to make a copy for your own record.

How are we supposed to use the laboratory notebook?

Is there any format for the notes, or are we allowed to pretty much scribble in the book?
The purpose of the laboratory notebook is to:
Record your design history including minutes of meeting, discussions, preliminary ideas and action items.
In the real world, this notebook will be part of the design history files.
In BN3101 we use this as a record of the progress of the project. Here are some ideas on how you may want to record your activities:
a. Schedule of project
b. Minutes of meeting
c. Sketches of drawings
d. Record of information shared amongst team members.
The Explanatory Notes in the lab book give you guidelines on how entries should be made.
You can record your activities either by hand writing the entries or if you wish use a printout and paste it into your notebook. Remember to sign across the edge of the printout.
In BN3101, the process of arriving at your final design is as important as the final design itself. Thus the notebook is a journal to record your progress in arriving at your final design. 

What is Wizfolio?

Wizfolio is a powerful tool for online journal reference management. It can be used as an academic social networking tool to academic community. In the context of this module, Wizfolio will be used for sharing information.  Each team is provided with a WizFolio account.

To learn more about Wizfolio, please visit www.wizfolio.com  

Where can I find examples of 510K's?

You can find examples of 510K's from the FDA website. Go to www.fda.gov website. Then click on Medical Devices on the left hand column. Then click on Databases on the right hand column. Then click on Premarket Notification on the left hand column. Then do a search. Sometimes it is easier to get what you want using the appropriate keywords in simple search.


Do we need to include costing in our user spec and design rationale?


How deep do we go into the Regulatory Issues? Do we just have to list out our strategy and approaches to get regulatory approval for our product or do we have to do the actual procedures?

Remember you are documenting Regulatory Issues pertaining to a rotator cuff repair design that you will be recommending to management to invest more money to further develop the product. You need to do a general review of the relevant regulatory issues and justify what regulatory pathway the product will likely take. For example if your proposed design is suitable for an 510K regulatory pathway, in order to bolster your argument you may want to prepare a draft 510(k) paper. 

We have previously come up with some design ideas for a clavicle fixation device. However, recently, we have searched the patents and found that our ‘ideas’ were already patented. Our group feels that we should also include these in our patent review report so as to illustrate how we change and adopt our current new design. We would like to seek your advice on this.

This is not an uncommon occurrence. If your design is similar to one in a issued patent, you have one of two choices. You can proceed with your original design and decide if you need to get a license. If you need to get a license then you must inform management about this so an informed decision can be made. Alternatively, you need to review the patent claims (to be covered in two lectures on patents) and design around the patent. Finally if you come up with improvements on the patented invention, you are eligible to file patents on your improvements.

What is Automatic Class III Designation and what regulations apply to devices under such classification?   

A medical device is automatically classified into Class III when there is no substantially equivalent predicate device. 
Some low risk medical devices have been automatically classified as class III because they were found not substantially equivalent (NSE) to any identifiable predicate device. Section 513(f) (2) allows for reclassification of these low risk devices into class I or II on the basis of established risk-based classification criteria. 

Evaluation of Automatic Class III Designation 

Is there a need to come up with metrics for the insertion device or will the user needs suffice?

If you are using the method I showed you in my lecture to derive the design spec it only make sense to come up with metrics based on the user needs.
The insertion device design spec is predicated by the design of the replacement kit itself. Depending on your the type of device you are designing, if the insertion tool is an essential part of the design then you will need some type of design metrics (design spec). In a wrist / ankle prosthesis, it is likely to be considered as primary and directly related to the user needs (both patient and surgeon). 

In the Design Control quality system template, under user specs portion, there is a segment requiring the acceptance criteria and regulatory factors. Should it be left to design verification/regulatory pathway personnel or should I provide a very brief summary? 

Remember the template that was given out is an actual document from an industrial case. It is not meant to be the definitive and the only way to proceed with your documentation. You have to use your judgment to decide what is appropriate for your situation at hand. 

Mention acceptance criteria and regulatory factors in general if you identify in your design spec that these need to be addressed in general, regardless of the type of design. The persons in charge of design verification/regulatory pathway will specifically the address acceptance criteria and the regulatory issues specific to the proposed design. 

What is a Humanitarian Use Device (HUD)? 

The FDA defines a HUD as a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year.  
A HUD, because of its small expected market, is not expected to ever be able to get the type of efficacy data required by ordinary premarket approval (PMA).   

What is the relationship between Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE)?   

A Humanitarian Use Device (HUD) is a device that has been given special approval by the FDA under the Humanitarian Device Exemption (HDE) regulations. The "normal" approval process for devices requires that companies demonstrate that the devices are safe and effective (better than medicine or another procedure). However, the FDA recognises that sometimes a condition is so unusual that it would be difficult for a company to scientifically demonstrate effectiveness of their device in the large number of patients that usually must be tested. In these special situations, they may grant a HDE provided that:

1) the device does not pose an unreasonable or significant risk of illness or injury and,

2) the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.

A Humanitarian Use Device may only be used in facilities that have an Institutional Review Board (IRB)* to supervise clinical testing of devices and after the IRB has approved the use of the device to treat or diagnose the specific disease.

FDA approval of the HDE is a marketing approval and, consequently, the device is not considered investigational.