Med Device Design: Exam 1

IP Strategy: What is the general total cost to to conduct a FTO Analysis?

$25,000 - $100,000

IP Strategy: What is the general cost to file patents internationally?

$250,000 - $500,000

IP Strategy: What is the cost of a patent attorney?

$300-$800 per hour

IP Strategy: What is the general total cost to prepare a Utility Patent for a medical device?

$6,000 - $14,000

IP Strategy: Define Offensive Strategies, in terms of IP protection.

- Anticipate the direction that a competitor may be headed. - Acquiring the competitor. - Licensing

Clinical Strategy: Ways to design and manage a successful clinical trial include:

- Collect data early on enrollment patterns from different centers - Examine the real data directly to look for early indicators and issues. - Beware of drawing inferences from small samples over large populations. -Resist the temptation to develop an overly ambitious study design

IP Strategy: Define Defensive Strategies, in terms of IP protection.

- Consider how will the device will be packaged - Consider if it can be used for another procedure - Continuation patent applications allows inventors to refine claims - Brainstorming sessions to think how to protect design and anticipate what designs may come out - Layered approach-Broad and narrow claims - Publish information

R&D Strategy: What are the short-term R&D objectives?

- Develop framework on how to develop initial technology with lowest amount of risk - Observe major resources and costs - Lay the foundation that helps the company continue innovating and developing future product innovations - Discover important insights to help IP

Clinical Strategy: What are some of the driving cost factors for clinical trials?

- Device - Procedure (physician/hospital) - Follow-Up Visits - Investigators - Data Management - Patient Recruiting - IRB Costs - In-house management

R&D Strategy: What are the long-term R&D objectives?

- Drive growth through product innovation - Create product development pipeline - Increase product differentiation and mitigate market risk

Regulatory Strategy:What are the downsides of a 510(k)?

- Easy for competitors to enter market - Must follow indications of predicate devices

Regulatory Strategy:What are the downsides of a PMA?

- Expensive - Safety & Efficient MUST be proven - Longer - Panel Review - Clinical Data necessary

Clinical Strategy: What should one consider when choosing Principal Investigators for a study?

- Experience -Track record -Conflict of interest -Ability to put things together

Clinical Strategy: What are FIM studies, and what is their purpose?

- First-in-man studies - Done before any large-scale studies, are small scale, and only focus on the device demonstrating safety

Clinical Strategy: What is GLP, and what is their significance?

- Good Laboratory Practices; set of guidelines that describes in detail how studies are performed and data are collected - GLP is always required when submitting 510K or PMA; Specify guidelines for safety, facilities, personnel, equipment, QA, record keeping (SOP) Very time consuming and expensive

Clinical Strategy: What makes up the design of a clinical trial?

- Hypothesis - Endpoints - Statistical Power / Trial Size - Choosing Investigators & Centers - Patient Enrollment

Clinical Strategy: What are clinical trial ENDPOINTS?

- Identifiable or quantifiable parameters in a study - How the efficiency of a device is measured - They must be reachable in a reasonable timeframe

Clinical Strategy: What is the IACUC, and what is their role?

- Institutional Animal Care and Use Committees - Oversee and evaluate all aspects of the company's animal care and use program

IP Strategy: When should one file multiple patents?

- It depends on the complexity of your design; more complex, more patents to gain approval quicker. - This may be advantageous if portions of the technology is going to be sold or licensing for royalties

Clinical Strategy: What are pre-clinical studies?

- Large-Volume studies - Usually on animals - Used to prove safety and effectiveness for humans - Animal survival is of major significance - Placebos are used

Regulatory Strategy:What are the benefits of a PMA?

- More difficult for competitors to enter market - Potentially exempt from liability cases

IP Strategy: What is a "High-Risk IP", and what is the required FTO Analysis solution?

- Multiple patents in direct conflict with desired IP position; Well written claims and difficult to invalidate. - Possible licensing agreements, careful risk mitigation strategy

IP Strategy: Describe the Patent Portfolio.

- Protect Inventions - Manage Competition - Ensure Design Freedom - Build Markets - Deliver Revenue - Drive Business Strategy

Clinical Strategy: What are some non-clinical studies, and what are their purpose?

- Prototyping, bench testing, simulated use and tissue testing, in-vivo testing - These studies are trying to address device functionality.

Regulatory Strategy:What are the benefits of a 510(k)?

- Quicker - Cheaper - Easier to modify - Less need for clinical data - No facility pre-inspection

IP Strategy: What is a "Medium-Risk IP", and what is the required FTO Analysis solution?

- Some patents in field, but claims are broad or irrelevant - Claims analysis, detailing limitations of every relevant claim; Develop risk mitigation strategy; Develop IP strategy to create dominant IP position in field

Clinical Strategy: What three things does one need for a clinical trial?

- Sponsor research site and staff - Data management - Good clinical practices (GCP)

Clinical Strategy: Define Case Control Studies

- Statistically compares outcomes of a group of patients treated with a new device or procedure to a matched group receiving no treatment - They are conducted by searching a database that has a list of patients using a particular procedure - Less expensive than randomized studies but the results are not as valid and always require additional follow-up

Regulatory Strategy: What factors must be made comparable, between the new and predicate device, to show equivalence in 501(k).

- The device must be comparable in terms of intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards

IP Strategy: What are some conditions to look for during the FTO Analysis?

- The patent may not have been applied for or granted - The patent may have lapsed - The patent may have expired

Clinical Strategy: What is the hypothesis of a clinical trial?

- What the study will approve or disprove - Tests whether the device being studied is equivalent or inferior to an existing standard

Regulatory Strategy: Describe the 501(k) process

- When the new device is compared to a predicate device, and shows substantial equivalence

IP Strategy: What is a "Low-Risk IP", and what is the required FTO Analysis solution?

- Wide-open IP landscape; Total freedom to operate - Develop IP strategy to create dominant IP position in field

Clinical Strategy: What is the "power calculation"?

- determine how many patients are required in the treatment and control groups to adequately test the hypothesis, based on statistical significance

Clinical Strategy: Why is it appealing to conduct clinical trials outside the U.S. [OUS], and what must be considered?

- larger access to patients and reduced costs - patient population has to be comparable (ethnically as well as treatment)

Regulatory Strategy: What are some strategies for 501(k) clearance?

- pick predicate devices strategically - demonstrate product will be marketed to the same clinical population as the predicate device - choose simple devices. - choose a competitor to show superiority. - creative marketing techniques (differentiation)

Regulatory Strategy: Regulatory Strategy is directly related too:

- sales and marketing approach, - clinical strategy - quality

Clinical Strategy: What are clinical trial surrogate endpoints?

- used when the timeframe for an endpoint is too long (i.e. shelf life testing = accelerated aging)

Needs Finding: What are the 3 steps to identify a problem?

1) Observe a specific clinical situation 2) Identify the problem in the situation 3) Re-shape the problem into a need

Needs Finding: Who should you observe when identifying a problem?

1) Patients 2) Practitioners 3) Facilities

What are the 5 types of prototypes?

1) Works-like model: - Demonstrates how the device works (technical feasibility) 2) Feels-like model: - Made of the final material or a surrogate material to demonstrate ergonomics, grip, eight, size, etc. - Serves for the human factors part of the design 3) Is-like model: - Performs the desired function and works as intended. - It can be used clinically D) Looks-like model: - Demonstrates what the device will look like in terms of shape, color and or packaging E) Looks-like/ is-like model: - Provides a combination of the previous two models - It functions and looks like the final model

R&D Strategy: What are the 3 key R&D activities?

1. Defining high-level R&D milestones 2.Using these milestones to identify and prioritize anticipated technical challenges 3.Creating an early R&D plan that identifies the engineering work, testing methods, resources and time required to solve these challenges

What are the 3 types of properties?

1. Real- something tangible and is not movable (house, land) 2. Personal- something tangible and movable (clothes, furniture, car, etc.) 3. Intellectual- intangible (ideas or concepts, inventions, works of art, music, product names, recipes)

Regulatory Strategy: What is the timeline of PMA?

180 days Can be extended another 180 days, or longer

Device Classes

Class I: Low Risk [i.e. floss, bandages] Class II: Moderate Risk [i.e. surgical tools] Class III: High Risk [i.e. prosthesis]

Clinical Strategy: What is a MARKETING consideration you should take when planning clinical trials?

Comparing new technology vs. standard technology

Regulatory Strategy: What are 3 factors that make regulatory strategy important?

Cost Time Effort

List the steps during "Needs Screening"

Diseased State Fundamentals Treatment Options Stakeholder Analysis Market Analysis Needs Filtering

Regulatory Strategy: In terms of IDE, when should the FDA review it? When should the IRB review it?

For devices with non-significant risk, the IDE should go to the IRB. If it is rejected by the IRB, or the device poses a significant risk, the FDA should (must) be notified

Clinical Strategy: What is the preliminary step before planning your clinical study?

Good literature search

Regulatory Strategy: What regulatory component is needed before trials can be initiated?

Investigational device exemption (IDE)

Regulatory Strategy: What is CE Marking?

Med. Device approval in the EU;

Regulatory Strategy: Can device manufacturers be sued if the device is approved via a PMA?

No

Regulatory Strategy: Does the FDA regulate the practice of medicine?

No. Practitioners can use device for other reasons

Clinical Strategy: What are some typical costs-per-patient for clinical trials?

Non-Implantable = $2,000 Implantable = $100,000

IP Strategy: Compare: Patent vs. Trade Secret

Patent: Expensive, expire, but legal safety and easier to defend than Trade Secret. Trade Secret: Less expensive (up front), never expire, but more difficult to defend. ..... NOT advantageous for devices than can be reverse engineered

Clinical Strategy: What part of the clinical-trial process is usually very time consuming?

Patient enrollment

Clinical Strategy: Compare Pilot vs. Pivotal vs. Postmarketing Clinical Trials

Pilot - early clinical trials usually conducted as registry. Pivotal trial - the definitive clinical trial conducted for FDA approval. Postmarketing - trials performed after the commercial approval of the device.

Regulatory Strategy: What is a PMA?

Pre-Market Approval: private license granting the owner permission to market the device (i.e. Regulatory Patent)

IP Strategy: Define: Intellectual Property (IP)

Product of the human mind or intellect that has some value in the marketplace and can be formed into a tangible form such as a device, software program, process or other invention.

Clinical Strategy: What are the three "gold standard" tests for Medical Device Testing?

Prospective - designed before the devices are tested Randomized - patients are randomly placed as control or trial groups for statistical purposes Controlled (Blinded) - study participants are blind from device

IP Strategy: How do many start-ups pay for Patent Attorneys?

Stocks

List the steps during "Needs Finding".

Strategic Focus Problem Identification Need Statement Development

Regulatory Strategy: With 501(k), when do you need to meet with the FDA?

When you have clinical data

Regulatory Strategy: Who is the easiest regulatory body to deal with, when a device is in the "grey zone"?

[CDRH]

Regulatory Strategy: Define CDRH, CBER, CDER, and OCP

[CDRH] - Center for Devices and Radiological Health [CBER] - Center for Biologics Evaluation and Research [CDER] - Center for Drug Evaluation and Research [OCP] -Office of Combination Products --- decide where product belongs

Clinical Strategy: Define Registry

collection of cases performed in a real-world setting which may be accumulated either prospectively or retrospectively after a number of cases have been performed

R&D Strategy: What is the goal of R&D?

develop a series of progressively advanced working models until all critical user requirements are met

R&D Strategy: What are the good input for R&D timelines?

good personnel, well prepared engineering resources and a good plan of the testing

Clinical Strategy: Define Observational Studies

performed after 10 to 100 FIMs were performed and more information is trying to be learned

R&D Strategy: Define R&D

the science and engineering work necessary to take an early-stage prototype to a user friendly device

Clinical Strategy: What must be justified to perform animal studies?

why an animal model is needed, with emphasis on ethical treatment of animal

IP Strategy: What are 4 ways IP is protected?

• Trade Secrets • Trademarks • Copyrights • Patents

Regulatory Strategy: What are the benefits of CE Marking?

•- Obtained quicker than PMA-due to data requirements •- Provides revenue stream •- Early user feedback on device performance •- Early clinical data that can be used •- Only requires a device show safety and performance

Regulatory Strategy: With PMA, what makes up "Safety and Effectiveness" data?

•-Data on biocompatibility •-Stress and fatigue •-Shelf life •-Physician training plan •-Instructions for use •-Post market surveillance plan •-Additional studies

Clinical Strategy: What are clinical trials?

•-Human studies performed to determine outcomes based on the use of a new medical treatment. •-Demonstrates that a new device is safe and effective in a clinical setting