Biomedical Innovations · 2027-02-24 · 80 minutes
Innovation-safety debate
Your goal: Debate how much safety testing an innovation needs before it reaches patients.
One product: CER contribution on pre-release safety testing requirements for medical innovations, plus two questions and a reflection linking the argument to the ER prototype.
If blocked, save locally and ask for help with the missing input or assignment access.
Start the work
A revision log makes a change and its reason traceable; a claim of improved performance needs its own evidence.
- Prepare two questions about balancing innovation speed with patient safety.
- Draft a CER position on the right level of pre-release testing.
- Debate with peers and capture the strongest opposing point.
- Connect the debate to your own ER prototype's safety claims.
- Submit two questions, one CER contribution, and a reflection.
Show the 80-minute plan
- 0 to 10 minutes. Original route: read H1 and the opening definitions; name the observed change and an unanswered question. Actual route: use a genuine finding and unanswered question from the assigned evidence instead, or ask for the missing actual input. Give one response only.
- 10 to 25 minutes. Original route: read C1/E1 and draft two questions and a short CER. Actual route: use the supplied assigned evidence/rubric instead.
- 25 to 55 minutes. Original route: use D1/O1, review the evidence, capture the strongest opposing point, respond and revise the same CER. Actual route: follow the teacher-approved discussion task instead.
- 55 to 65 minutes. Original route: read P1 and add the short fictional connection. Actual route: use the genuine prototype and evidence instead; ask for missing inputs.
- 65 to 77 minutes. Use Q1 on the same product, update S1 work checks and use the linked assignment or save locally if blocked.
- 77 to 80 minutes. Record actual presentation readiness or one missing input/next action. Do not build another deck in this slot.
Open your materials
Use the reading, word guide, and worked example below. Keep your answers on paper or in one document.
Printable lesson and response record (PDF). This packet contains the same required reading and work.
Question: Which safety claim is supported, and what evidence is still missing?
Words you will use
- innovation
- A new or changed design or approach.
- pre-release
- Before a design is made available for its intended real use.
- safety testing
- Evaluation intended to reveal whether a design can cause harm under relevant conditions; this task supplies no testing procedure.
- claim
- A statement you argue is justified.
- evidence
- An identifiable observation or record used to support a statement.
- reasoning
- The explanation linking evidence to a claim.
- CER
- Claim, evidence and reasoning presented together.
- risk
- The possibility of harm considered with its likelihood and severity; no measured risk is supplied here.
- harm
- An adverse consequence.
- possible benefit
- An improvement that might occur but is not established simply by proposing it.
- uncertainty
- What available evidence does not settle.
- tradeoff
- A choice in which competing priorities or consequences must be considered.
- stakeholder
- A person or group with an interest in a decision.
- value judgment
- A stated preference about what matters, distinct from an observed result.
- counterargument
- A reasoned point challenging or qualifying a position.
- response
- An answer that addresses another argument using reasons and evidence.
- prototype
- A preliminary representation of a design.
- paper comparison
- A check of supplied words or drawn relationships, without observing real use.
- performance
- How a design functions under stated conditions; a paper revision does not measure it.
- limitation
- A boundary on what evidence can establish.
- evidence gap
- A needed input or observation that is missing.
- criterion
- A stated requirement used to judge a specific feature.
- constraint
- A limit a design must preserve.
- revision
- A documented change to a prior version.
- failure mode
- A way a design might fail to do what is intended, not a measured event unless observed.
- accessibility
- Whether people with differing needs can access and use a design; no accessibility result is supplied.
- authorization
- Permission from the responsible authority; a classroom argument grants none.
- official completion
- Work completed under the actual enrolled task's requirements, supported by evidence.
- Schoology submission check
- Confirmation that a submission reached its intended destination.
H1: Start with the evidence boundary
The teacher selects one route. With the assigned debate case, evidence and rubric, use that actual work instead of the original practice. Without them, use the fully supplied fictional paper case below. Neither route gives a medical release authorization.
Opening example: a fictional sign changes from “Guest Area” to “Waiting Room” to match its destination door. The words now match. Nobody checked whether a visitor noticed the sign or arrived safely. A paper correction supports a claim about matching words; it does not establish safe use.
Opening, original route: name the observed change and one unanswered safety question using H1 only. Actual route: use one genuine finding and unanswered question from the teacher-assigned evidence instead; skip the fictional sign response. If that actual input is missing, ask the teacher for it. Give one chosen-route response only. Neither route requires personal medical experiences or patient information.
Innovation means a new or changed design. A possible benefit is an improvement someone hopes for; a possible harm is an adverse consequence. Neither is an observed outcome merely because someone names it.
C1: A complete fictional review question
Original route only. A classroom team proposes a visitor-information display for a fictional ER. Its scope is destination words and a drawn route. It makes no diagnosis, triage decision or treatment recommendation. This is a paper design discussion; there is no actual hospital, patient, device trial or release decision.
Question: what evidence would be needed before this proposed display could reasonably carry a claim of safe real use? Choose and defend a bounded recommendation. You may say the available evidence cannot decide the needed extent of testing. Do not invent a test result, required legal sequence, calendar delay or acceptable risk threshold.
Position A: withhold a claim of safe real use until relevant use conditions, possible harms and authorized evaluation evidence are supplied. Paper consistency alone leaves critical questions unanswered.
Position B: allow the proposal to advance to a design-review presentation now, clearly labeled “paper consistency checked; safety not established,” while withholding real release. Waiting to share even a limited proposal could delay feedback. No delay length or benefit is measured.
These positions emphasize different next steps; they need not disagree about withholding real release. The genuine tension is how to progress with an unproven idea while keeping claims within evidence. Your CER must address the safety-evidence requirement, not merely vote for a presentation.
Stakeholder priorities are classroom stipulations: a visitor advocate values understandable directions; a design team values timely feedback; a safety reviewer values finding and addressing consequential failure modes. No stakeholder interview occurred. A value judgment states which priority you emphasize and why.
E1: Supplied paper evidence and unknowns
E-A, fictional document comparison: the earlier sign read “Guest Area,” while its chart destination and door read “Waiting Room.” The revised sign, destination and door all read “Waiting Room.” The comparison supports consistent naming only.
E-B, fictional route comparison: the only plan route is entrance to lobby, then corridor to Waiting Room door. The earlier chart had a direct lobby-to-room arrow through a wall without a door. The revised chart includes the corridor step. No room, door or corridor was added.
E-C, evidence inventory: no actual user observations, accessibility review, failure analysis, emergency-condition evidence, measured outcome or authorized safety evaluation is supplied. These are missing inputs, not findings that the proposal is dangerous or safe. No probability or severity ranking has been measured.
E-D, scope record: this exercise compares written labels and drawn connections. No real building, clinical workflow, staffing plan, patient-care action, physical prototype or operating display exists in these records. Thus paper agreement cannot establish clinical effectiveness or safety.
Use E-A or E-B for a specific supported paper claim. Use E-C/E-D to explain the limit. The records come from one fictional case, not independent studies. Naming two IDs does not make them independent or prove safety. Actual route: use the teacher-assigned debate, genuine evidence and rubric instead; skip the original case-specific response. Do not do both.
D1: Debate or complete the same argument alone
Original route: prepare two questions that seek missing evidence or expose a priority tradeoff. Then draft a short CER: one bounded claim, one paper fact from E-A/E-B, one limit from E-C/E-D, and reasoning connecting them. Identify one value judgment separately from observed evidence. No word quota or second essay is required.
With an available teacher-approved peer discussion, take turns stating a claim and its evidence, asking a question, and paraphrasing the strongest opposing point. Respond with a named record and revise or retain the same CER. Identify a comment as a peer comment only if it was actually made. Follow the teacher’s participation directions.
Solo opposing argument O1, fully supplied: “Holding every proposal until all uncertainty disappears can prevent useful feedback. E-A and E-B show specific paper improvements. Present those limited improvements now, disclose E-C’s gaps, and do not claim permission to release.” This argues for feedback with disclosure, not for exposing patients to an untested system.
Solo route: label O1 “supplied opposing argument,” capture its strongest point, respond using a record and revise or retain your original CER. A defensible response can accept limited presentation while explaining why real-use safety claims still need relevant evidence. If your first position already matches O1, test it against Position A’s concern that an audience may mistake advancement for approval; make the claim boundary explicit.
Recovery: separate “the labels match” from “the display is safe.” Locate E-A for the first and E-C/E-D for the gap. Use that distinction to finish the same CER, both questions and opposing-point response. A written solo exchange does not prove peer participation or complete an assigned online reply. Actual route: use the teacher-assigned debate, genuine evidence and rubric instead; skip the original case-specific response. Do not do both.
P1: Full fictional prototype connection
Original route only. The following is the February 22 fictional visitor-information case, included in full for this connection. It is not your actual ER prototype. Use it to link one revision to the debate’s evidence limit; do not produce a new revision log.
B1 brief: help a reader match a destination name and a drawn route. C1 criterion: the sign, chart destination and destination door use the exact name “Waiting Room.” C2 criterion: every chart connection follows the shown plan. C3 constraint: keep the existing rooms, doors and corridor; add no opening or space. These are exercise rules, not building codes.
P1 plan, complete text equivalent: an entrance opens into a lobby. A corridor connects the lobby to the Waiting Room door. The lobby and Waiting Room share a wall with no door through it. There is no direct lobby-to-room connection; the corridor is the only shown route. The Waiting Room door says “Waiting Room.” The lobby sign says “Guest Area.” No other spaces or connections exist in this model. The plan is not to scale.
T1 chart, complete text equivalent: START is “Enter lobby.” An arrow goes directly to END, “Arrive at Waiting Room.” It omits the corridor step and describes a direct lobby-to-room connection through the wall. These are the only two nodes and the only arrow.
P2 revised paper plan: every P1 room, door and connection is unchanged. The lobby sign now says “Waiting Room”; the destination door still says “Waiting Room.” Nothing else changed.
T2 revised paper chart, complete text equivalent: START “Enter lobby” connects to ACTION “Follow corridor to Waiting Room door”; ACTION connects to END “Arrive at Waiting Room.” Those are all three nodes and both arrows. No clinical route or new physical connection is added.
P2 and T2 are supplied completed fictional paper versions. Their changes are implemented in these paper records only. No actual prototype was changed and no user performance was measured.
Original route only. R-A simulated review comment: “The lobby sign says Guest Area, but the door and destination say Waiting Room. Compare all names with C1.” The mismatch is visible in P1/T1.
R-B simulated review comment: “T1 describes a direct route through the wall. P1 only shows a corridor route. Compare each connection with C2.” Check both P1 and T1 rather than treating the comment alone as proof.
R-C simulated suggestion: “Add a new door through the shared wall and keep the direct chart.” This is the rejected alternative. Check it against C1, C2 and C3 to name the rule it conflicts with.
Reflection on this supplied case: name one P1-to-P2 or T1-to-T2 change, the criterion it meets, and a safety claim that these paper records cannot support. State which actual prototype input would be needed for your genuine connection. Actual route: use the teacher-assigned debate, genuine evidence and rubric instead; skip the original case-specific response. Do not do both.
Q1: Review the one combined product
Original route: retain two questions, one CER, the strongest opposing point with your response, and the prototype reflection in one document. The CER should distinguish a checked paper fact, an evidence gap and a value judgment. Its recommendation must not authorize patient use.
Check whether your counterargument response engages the strongest point rather than claiming the other side ignores safety. Keep or revise your position and name the record that supports that choice. This is a check on the same CER, not another contribution.
Actual route: check only the genuine assigned product and teacher rubric. The original two-record pattern and paper case are not authentic quotas. Preserve the dated two questions, CER and reflection unless the teacher changes the assignment; do not invent a peer response or real prototype evidence.
Both routes: read back any claim of better, faster or safer. Identify its actual evidence or change it to a proposed benefit, unanswered question or limited paper finding.
S1: Work checks, assignment and next class
Keep ten checks distinct: assigned debate instructions; genuine case/evidence; teacher rubric; actual peer discussion or assigned online exchange; actual ER prototype/version; prototype performance/safety evidence; presentation readiness; assignment access; official completion; whether Schoology shows Submitted. Give a brief non-private basis for what you did or a next action you need. Begin notes during work and update only changes; an existing record can serve.
Original practice does not show that the corresponding actual work was completed. Solo O1 is not a classmate comment. A presentation preview is not an extra deck-building task. For February 25, record ready only if the actual presentation is ready; otherwise name the missing input or next action.
Confirm today’s enrolled instructions with the teacher. Do not infer an official debate activity or completion from this preparation.
Open the linked BI assignment and check its posted deadline and submission format. Open the linked BI assignment and follow its posted instructions. If blocked, save locally and record the missing destination and next action. After uploading, check that Schoology shows Submitted; saving a file does not upload it.
Keep private records, patient information and personal medical histories out of this paper task. No actual experiment, patient testing, construction, external posting or clinical action is assigned by this preparation.
M1: Different non-clinical CER model
Optional method example: a fictional library shelf directory has two versions. L-A labels a shelf “Travel” but the directory says “Trips.” L-B changes the directory to “Travel”; the shelf stays “Travel.” L-C states that no reader observation occurred. Criterion: directory and shelf labels must match. These are invented paper records, not research results.
Worked CER: “L-B meets the label-matching criterion. L-A had different words and L-B repeats Travel at both locations. Matching words satisfies the stated criterion, but L-C leaves successful reader navigation untested. I recommend showing this limited correction for review, without claiming faster navigation.”
Worked counterpoint: “The word Travel may still be unclear to a reader.” Response: “That does not undo the exact matching finding, but it identifies another unresolved requirement; no evidence here resolves clarity.” This separates an observed paper match from an unmeasured benefit.
Use the method, not its library facts, in the ER debate. Actual route: follow the genuine case and rubric instead; no library response is required.
Try the decision
Original route: a presenter says E-A/E-B prove the display is safe for patient use. What revision is justified? Actual route: use the genuine case claim and teacher rubric instead; skip this practice decision.
- State the limited paper matches and explicitly keep real-use safety unestablished.
- Keep the patient-use safety claim because the revised version looks better.
- Treat E-C’s missing evidence as proof that harm definitely occurs.
Explain your choice using the reading. Discuss it or say it to yourself. This practice does not add another submission.
Your response record
Use these labels on paper or in your document. The space below also works when this page is printed.
Chosen route: separate finding from question
Original route: from H1, name the sign change and one unanswered safety question. Actual route: name a genuine finding and unanswered question from the assigned evidence instead, or ask for the missing actual input.
Original route uses H1 only. Actual assigned evidence replaces the fictional sign response; do not complete both. Neither route requires a personal medical example.
Chosen route: prepare two questions
Original route: write two questions about needed evidence or competing priorities in C1/E1.
Actual route: use the teacher-assigned debate, genuine evidence and rubric instead; skip the original case-specific response. Do not do both.
Chosen route: draft one bounded CER
Original route: answer C1’s safety-evidence question with a paper fact, a limit and reasoning; identify one value judgment.
Actual route: use the teacher-assigned debate, genuine evidence and rubric instead; skip the original case-specific response. Do not do both.
Chosen route: engage an opposing point
Original route: record a genuine peer point if available, or label and use supplied O1. Respond with a record and retain or revise the same CER.
Actual route: use the teacher-assigned debate, genuine evidence and rubric instead; skip the original case-specific response. Do not do both. Solo writing does not establish actual peer participation.
Chosen route: connect the prototype
Original route: use the full P1 case to identify one change, its criterion and an unsupported safety claim; name a missing genuine prototype input.
Actual route: use the teacher-assigned debate, genuine evidence and rubric instead; skip the original case-specific response. Do not do both.
Both routes: retain one product and accurate work checks
Check the combined document against Q1. Record the S1 work checks and the next presentation input or action.
Actual route uses the real rubric and existing work-check record. Check readiness, official completion and Schoology submission using genuine evidence rather than inventing them.
Check your product
- Both routes: retain the dated two questions, one CER contribution and prototype reflection in one combined product.
- Original route: distinguish a named paper fact, a missing safety input and a value judgment; answer the strongest supplied or genuine opposing point.
- Actual route: the assigned case, evidence, debate and teacher rubric replace all original-case counts and practice responses. Do not complete both.
- Both routes: describe the source of the opposing point honestly and check real prototype evidence, presentation readiness, official completion and Schoology submission separately.
A fictional paper comparison supports only the stated label/connection findings. It cannot measure risk, establish patient benefit, authorize clinical use or complete authentic debate, prototype or submission work.
Turn in your work
Wk6 CER: Innovation-safety debate
Use the linked February 24 BI assignment and check its rubric, format and posted deadline. After submitting, check that Schoology shows Submitted.
Open this assignment in SchoologyIf blocked, save locally and ask for help with the missing input or assignment access.
Connection to PLTW
Original innovation-safety paper debate; actual enrolled activity and submission remain unconfirmed.
These references locate related course material. Complete only the official work and stopping point your teacher assigns. This local preparation does not establish completion of an online activity.
- Project 2.1.1 Scientific Research
Optional practice and examples
Use these resources to practice related skills. Follow the required work and evidence limits above. A simulation does not authorize a live experiment or add another submission.
Open the worked example. Compare the method with your own work; retain your assigned records and product.
Slides and optional notes
Original route: one combined document holds two questions, one CER, its opposing-point response and the fictional prototype reflection. Update brief work checks on the same record. Actual route: genuine assigned case/debate/prototype/rubric replaces every original practice field and count; no duplicate paper debate. Guided notes are optional and do not add a second submission.
Keep going
If you were absent or lost your place, read the word guide and reading first. Try the example, then complete the first unfinished response.
No partner is required. Read your response aloud to yourself and check it against the product checklist.
Take home: A bounded recommendation separates checked evidence, unanswered safety questions and the values behind the choice.
On February 25, present the ER redesign with claims that match the evidence actually available. Which evidence will you show for the redesign's most important claim?
