Medical Device Regulatory Pathways

Task 2 – Employer introduction: students will schedule a meeting with the employer to introduce themselves and become familiar with the business. Meetings can be virtual or in-person, whichever the employer prefers. Care should be taken to record minutes from this meeting using the template provided. Submission/uploading of completed minutes will be required.  Students will receive coaching for this task from their project coordinator.

Task 3 – Problem analysis: students will review the problem scenarios, select one on which to focus, and complete an in-depth study (resources provided). An analysis template is provided which students utilize to submit. Employers will respond and provide comments.

Problem statement #1: Medical device development is challenging because of the regulatory requirements. This is why it is critical to be familiar with regulatory requirements before beginning the development. Read the link and view the video below to learn more about the need for an improved medical device known as ureteral stents. The problem with any sort of urinary tract medical device is its short-term usefulness. These, unlike other types of stents, will become calcified. How can such a device be made which does not become calcified?
    Ureteral stent purpose and indications https://my.clevelandclinic.org/health/treatments/21795-ureteral-stents
    Ureteral stent placement and removal https://youtu.be/byrXGUAlZYc?feature=shared  

Problem statement #2: One of the challenges encountered with medical devices is sometimes their application to a small number of people, which makes it difficult to recoup the investment in the development and approval process. Some of these diseases are known as “rare diseases.” For example, epilepsy is not generally considered a rare disease, but some forms of it are. What path might an App which detects epileptic seizures follow to become marketable?
    Rare Epilepsies https://epilepsynewengland.org/rare-epilepsies  
    Medical products for rare diseases and conditions https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions

Problem statement #3: Medical devices that are coated with a drug substance belong to a unique set of medical devices. For example, some vascular stents elute a drug substance to enhance its effectiveness. How are these medical devices classified? Your team should propose a new type of medical device with this classification.
    Eluvia DES https://www.bostonscientific.com/en-US/medical-specialties/vascular-surgery/drug-eluting-therapies.html
    Coronary drug-eluting stent classification with FDA https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NIQ

Select one of the 3 problems to analyze. Write and submit a problem analysis on the following template.

Task 4 – Parameter characterization: students will examine the various parameters involved in the process (resources provided). These characterizations will be completed on a template and serve as the toolkit for solution development. Employers will respond and provide comments.

Parameters in medical device development include the following:

1. Device classification

a. Determining if it is a medical device

b. Classification

c. Pathways to market

2. Scientific evidence

a. Types of scientific evidence

b. Potential costs

c. Order of experiments

d. Documentation