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