BME 498

What is prevalence?

- a measurement of all people afflicted with the disease at a given point in time

Assume that children with asthma have a 25% annual hospitalization rate and that the average cost of hospitalization is $5,000. If insurance provider X cares for 10,000 children with asthma, what is the expected annual value ceiling for a new technology if it reduces hospitalizations in this provider's population by 20%?

- $250 per child - 10,000 children x 25% x $5,000 = $12.5 million - $12.5 million x 20% / 10,000 = $250 per child - another way to think about this calculation is that $250 represents the upper per-child limit that this provider would be willing to pay for a new technology that delivers the promised results - in reality, the provider would want to share in this saving - using the rule of thumb, the company might only be able to charge $125-175 per child for the new technology

In order to motivate decision makers to change their current behavior and adopt a new technology, innovators should expect to share roughly what percentage of any potential savings (or other economic benefits) associated with addressing an unmet need?

- 30-50% - although this can vary quite a bit based on the technology, the rule of thumb presented in the textbook is that innovators will need to share from 30-50% of the savings with purchasers in order for a new solution to be considered compelling enough to adopt

What percentage of all medical technologies are considered high risk, class III devices?

- 5-10%

Within how many days of its receipt is the FDA required to review a traditional 510(k) submission?

- 90

What is true with regards to Accountable Care Organizations (ACOs)?

- ACOs are voluntary consortiums of independent physician groups, hospitals, and insurers - ACOs share responsibility for caring for a defined population of medicare beneficiaries over a defined period of time - ACOs have incentives that change the interests of the involved stakeholders and can affect their receptivity to certain types of medical innovations

According to the textbook, if innovators get ideas for solutions to a problem while working on their needs they should do what?

- Briefly capture them in their notebooks and then set them aside until later in the process - Simple notes can be made for consideration at a later date, but innovators should work diligently to remain "solution agnostic" during the early stages of the biodesign process.

Best definition/example of how beneficence would be applied in medical device development.

- Doing good

Best definition/example of how autonomy would be applied in medical device development.

- Exposing the risks and benefits of a trial to patients and allowing them to decide whether or not to participate

T/F: An innovator's "acceptance criteria" for choosing projects to work on should be based on his/her personal mission, strengths, and weaknesses rather than factors in the external environment.

- False - Acceptance criteria should take both internal and external factors into account.

T/F: When it comes to identifying and validating important unmet medical needs, the physician's point of view should always be given top priority.

- False - The physician's perspective is one of many POV's to consider including the patients, other types of providers, the facilities where care is delivered, third-parties such as health insurance companies, etc.

Patients are provided comprehensive federal protection for the confidentiality of the their personal health information under what act?

- Heath Insurance Portability and Accountability Act (HIPAA) - Understanding the requirement of HIPAA is essential prior to needs finding and remains relevant throughout the biodesign innovation process

What are some value "signposts" that may point to interesting innovation opportunities?

- Potential to change the location of care to a less expensive venue - Potential to shorten the length of the hospital stay - Potential to address complications or outcomes where a reimbursement penalty has been (or will be) implemented - At this stage of the process, innovators typically should be focused only at a high level on how a procedure or interaction is generally paid for and by whom. More detailed research around reimbursement, coding, etc. comes later. Understanding existing or impending reimbursement penalties is slightly different because the information is more general in nature.

Best definition/example of how non-maleficence would be applied in medical device development.

- Providing the greatest benefit and the lowest risk

Best definition/example of how justice/fairness would be applied in medical device development.

- Reporting negative results from a clinical trial to prevent the repetition of studies that do not benefit the patients

T/F: Conflicts of interest in medtech innovation can be minimized but often cannot be completely avoided.

- True - Given the complexity of the healthcare medical technology landscape, some conflicts of interest are inevitable; the innovator's goals should be to minimize their occurrence and ethically address and resolved them when they arise

What are effective guidelines for conducting interviews?

- Try not to ask yes/no questions. Instead of asking binary questions that can be answered in a single word, use an open-ended approach that starts a conversation. - Ask the interviewee for specific examples rather than having them explain what typically happens. Stories about specific occurrences are far more likely to lead to relevant insights than a generalized description. - Pay attention to nonverbal communication. Body language and emotions can be just as informative as what's being shared verbally.

What is true regarding killer risks?

- a killer risk is a problem so severe that it makes it clear that the project cannot proceed - the identification of killer risks is a good thing

What is an example of an effective need statement?

- a way to reduce the incidence of urinary tract infections in ICU patients that reduces hospital stay - the recommended format for a need statement is "a way to address [problem] in [population] that [outcome] and does not include a solution bias

What is the FDA's intereseted in regulating according to the new guidance for mobile medical applications?

- all mobile apps that meet the definition of a medical device, independent of the risks they pose to patients

What are characteristics that relate to a top-down market analysis?

- begins with an overall spending on the disease state, the divides total spending into categories based on the percentage of customers in each segment - assumes the same spending per patient across the various segments

What device classification would a scalpel be?

- class I

What device classification would an infusion pump be?

- class II

What device classification would suture materials be?

- class II

What device classification would x-ray machines be?

- class II

What device classification would a heart valve be?

- class III

What device classification would breast implants be?

- class III

When validating preliminary need statements, innovators should ask members of the target audience to do all of the following:

- elaborate on the problem and its potential cause(s) - explain what result (or outcome) they would most like to resolve in seeing the need addressed - outline any criteria that new potential solutions would have to meet in order to satisfy them - at this stage, innovators should focus exclusively on understanding the problem, population, and desired outcome(s) as well as what general criteria must be met in order to address a need NOT what any specific solutions might be

T/F: Products on the exempt pathway (elastic bandages, tongue depressors, bedpans) are the only devices that do not have to comply with FDA's "general controls"

- false

T/F: When it comes to choosing predicates to support a 510(k) submission, innovators should work with a regulatory consultant to explore creative strategies for using multiple and/or split predicates

- false - a company may choose more than one predicate device to make the argument of substantial equivalence - FDA will not allow "split predicates"

T/F: Physicians and other innovators with medical training can bypass disease state research if they're generally familiar with the medical condition of interest

- false - all innovators should invest time in disease research to confirm their understanding and help catalyze disease-related insights

T/F: According to the textbook, there's no limit to the number of must-have criteria that innovators define, as long as the requirements are central to addressing the need in the minds of decision makers

- false - creating too many absolute criteria (more than 6-8) will place too many constraints on concept generation and screening - innovators should stay focused on the few criteria that are absolutely essential to address the need

T/F: "Classic" group brainstorming without judging/criticism consistently results in the greatest output of creative ideas when compared to techniques that rely on constructive conflict

- false - different studies suggest that individual ideation approached and/or techniques that promote constructive conflict can be more productive than classic brainstorming in certain situations - innovators should experiment with different methods and evolve toward the approach that they personally find most effective

T/F: Regarding the size of a market, bigger is always better when it comes to attracting investors in the current medtech environment.

- false - in some cases, a smaller market that is easier to access may be more attractive than a larger market in which the potential purchasers of an offering are difficult to reach

T/F: Typically, drug solutions do not need to be considered by medtech innovators because they have a different regulatory, sales, and marketing pathway

- false - innovators are encouraged to perform a comprehensive search of existing solutions, being careful not to overlook any relevant diagnostics, intervention or surgical therapies, or management tools and services

T/F: In the complex medical technology sector, the interests of all stakeholders (patients, physicians, facilities, and payers) should be given equal priority.

- false - innovators are well-served to consider the interests of all stakeholders but ultimately they will have to prioritize the requirements of the most important and influential stakeholders, known as decision makers, to drive adoption of a new technology

T/F: On multi-disciplinary teams with business, engineering and medicine students, disease state research should be the responsibility of the most medically-experienced team members

- false - team members from all backgrounds should be involved in disease research bc insights may be generated from their multiple points of view

T/F: Assessing willingness to pay is equivalent to understanding how much decision makers currently spend on existing solutions.

- false - understanding willingness to pay is not the same as asking how much the segment is currently paying for an existing solution since new solutions are likely to be held to a different standard

T/F: Given the increasing focus on healthcare cost containment, innovators should focus on obtaining detailed reimbursement information during needs screening rather than just understanding the general costs of associated with providing existing solutions in the need area.

- false - at this point in the process, the innovators' focus should be on understanding the general costs of providing existing solutions (diagnosis, drug cost, procedure, hospital stay, rehabilitation, ongoing management) as well as potential cost savings for using one particular solution versus another at the individual and system level - the specifics of reimbursement will be layered into the analysis after the innovator has a better sense of the new solution they might develop and how/where it fits into the solution landscape

What model would be most appropriate to address the question: how will users respond to the proposed material for the concept?

- feels-like model (FL)

When deciding on a final need statement innovators should avoid what?

- framing the need in negative vs positive terms - linking the need to a prevailing technology - signaling the direction the team might take when coming up with a new solution - innovators should carefully evaluate every word that is chosen in the final need statement b/c different wording can eventually lead to dramatically different solutions

What are innovators encouraged to do when performing disease research?

- get a basic understanding of a disease state through a review of medical textbooks and other references, then move on to a more in-depth review of historical and current clinical literature - take an iterative approach to disease state research such that increasingly comprehensive and detailed information is being gathered as the number of needs under consideration declines - use the citations from interesting papers and articles to help identify other valuable sources - innovators should generally engage experts only after they have performed basic research in an area and are knowledgeable in the space

What is not typically a useful guideline for a brainstorming session?

- have at least one person online during the session to check the feasibility of ideas that are suggested

What are the implications of including an outcome in the need statement?

- helps keep innovators focused on the results that their eventual solution must deliver to satisfy the target population - foreshadows the value that a solution would bring if it appropriately addresses the need - should be done in such a way that the outcome is objective and can be easily measured - can be implied but is more effective stated directly to eliminate any ambiguity - innovator should make the primary outcome they hope to achieve an explicit part of the need statement for all of these reasons

What should innovators consider when researching existing solutions?

- how the solution landscape may look several years in the future - solutions that have been tried and failed in the past - gaps between current and desired clinical outcomes provided by existing solution - gaps related to specific patient segments or stages of a disease

What should innovators do when developing a value estimate?

- identify who the real decision-makers are with respect to adopting new solutions in a need area - determine how significant decision-makers perceive the need to be and to what degree available solutions are effectively addressing the need - approximate how much margin there is to offer a new technology with a different improvement/cost equation in the need area - although it may be difficult for innovators and stakeholders to think about the value of a need area rather than a specific solution, it is important to keep this analysis solution independent so as not to positively or negatively bias the outcome

What should every need statement include as defined in the biodesign innovation process?

- include a problem, population, and outcome - be grounded in one or more specific observation - innovators should actively avoid embedding a venue or solution in a need statement to avoid unnecessary constraints

What are features of a productive medtech ideation environment?

- low-resolution prototyping supplies such as paper, pipe cleaners, legos, etc - medical props - sugar, caffeine - ample space to move around

What must innovators rely on when deciding on a preliminary target market?

- making educated assumptions - benchmarking - proxy analysis - expert analysis - expert input - innovators are working with imperfect information at this stage of the process, so they must make an educated guess about the best way to proceed based on the information they have gathered and their own instincts

What are characteristics that relate to a bottom-up market analysis?

- may require data that is not readily available at this point in the biodesign innovation process - is the most precise method for estimating the value of a market segment - derives the total market size by multiplying the number of customers within each market segment by the associated costs of their treatment

Requirements of regulatory approval in Europe are?

- medical devices bearing the CE marking can circulate freely and be sold and marketed according to approved indications throughout more than 30 European countries - CE standard is based on safety and performance, which has traditionally been less rigorous than the safety and effectiveness standard applied by the FDA - "conformity assessment" for medical devices in Europe is not conducted by a central regulatory authority

What should a need specification do?

- present the need statement - summarize relevant data gathered through the needs screening process - outline the need criteria any solution must address in order to satisfy the need - need specification should be completed before any solutions are considered

How should need criteria ideally be?

- quantitative and measurable - based on benchmarks uncovered through observations, research, and validation interviews - sufficiently high level that they do not imply a specific solution

What is an example of a rule that is not apart of traditional brainstorming?

- question everything - innovators are encouraged to defer judgement and encourage wild ideas without immediately questioning their feasibility

Why is it important to question how, when, and why existing solutions are administered?

- sometimes norms are established over time that may be suboptimal in some important way - diagnostic and treatment paradigms can become dogma

What is epidemiology?

- the causes, distribution, and control of disease in a population

What is mortality?

- the death rate associated with a disease

What is pathophysiology?

- the disturbance of normal anatomy and physiology caused by a disease or other underlying physical, mechanical, electrical, or biochemical abnormality

What is incidence?

- the rate at which a disease occurs - the number of new cases diagnoses per year

What is morbidity?

- the severity of the disease and its associated complications

T/F: During ideation, innovators are fundamentally focused on generating ideas that address the need statement and satisfy the need criteria.

- true - ideation is particularly useful after innovators have developed a need specification and are ready to begin thinking about different solution concepts to address the need

T/F: An effective market segmentation scheme identifies subsets of a total population with the greatest similarity while maintaining maximum differences between the groups.

- true - market segments should also be measurable, accessible, durable (so as to not change too quickly), and substantial enough to be profitably and/or sustainably served

T/F: One goal of need scoping is to establish the need as broadly as possible while keeping it linked to a specific, validated problem.

- true - need scoping helps innovators focus on the greatest relevant population without over-generalizing the problem

What is true regarding off-label use of an existing solution?

- use of a technology is considered off-label in the US if it deviates from the indications on the FDA approved label - in the US the manufacturer of the device is not allowed to promote any methods of use for the technology other than those cleared by the FDA - in some cases, technologies can achieve widespread adoption on an off label basis

What are some tips for effective concept explorations?

- when prototyping small devices, consider scaling up 5x to 10x to make the initial exploration process easier during preliminary experiments - keep detailed notes (measurement, techniques, materials, etc) regarding exactly how the first prototype was constructed so that the process can be replicated - protect all technology that is developed as a result of the prototyping process and use non-disclosure agreements with any contract suppliers/shops

What is cycle of care not the optimal approach to determine?

- which stakeholders are most likely to be decision makers when it comes to purchasing new technologies - flow of money analysis is a more appropriate approach for determining who finances the cycle of care and as a result who is most likely to be a decision maker when it comes to adopting new technologies (and incurring their cost)

What is the correct order of prototyping guidelines?

1. identify the questions to be addressed 2. choose the best category of prototype (type of model) 3. identify the functional blocks of a solution 4. understand what is known about each functional block 5. define more detailed design requirements and technical specifications

What is user-testing (UT)?

= evaluating a concept by testing it with various stakeholders to gather their input and observe their interactions with it

T/F: The more technical questions a team seeks to answer by developing and testing a single prototype, the more quickly it can progress through the prototyping process.

= false - the more questions a single prototype seeks to answer, the more risk an innovator faces in understanding the results of the model

What are the risks to early prototyping?

= getting swept up in creating a working model before they are certain that the solution meets the must-have need criteria, becoming attached to a concept once it takes a working form despite fundamental flaws that may affect the technical feasibility of a final product - gathering negative feedback before you get too far in the development cycle is an invaluable benefit of early prototyping, not a risk

What model would be most appropriate to address the question: will the overall concept perform as intended in a living system?

= is-like model (IL)

What model would be most appropriate to address the question: how will users respond to the form factor of the concept?

= looks-like model (LL)

What is tissue testing (TT)?

= testing features or functions of a prototype using animal or cadaver parts

What is bench testing (BT)?

= testing individual materials, methods, or functionality in a small-scale, controlled environment

What is simulated use testing (SUT)?

= testing various features or functions of a prototype as a system on an anatomical model or proxy

T/F: When developing a prototype, breaking down a concept into smaller "functional blocks" can be important in helping an innovator better understand which aspects of the concepts are truly novel and which aspects represent the highest degree of risk that need to be "proven".

= true

What model would be most appropriate to address the question: will the concept perform a specific function as intended?

= works-like model (WL)