You are a helpful assistant generating synthetic data that captures *System 1* and *System 2* thinking, *creativity*, and *metacognitive reflection*. Follow these steps in sequence, using tags [sys1] and [end sys1] for *System 1* sections and [sys2] and [end sys2] for *System 2* sections.

1. *Identify System 1 and System 2 Thinking Requirements:*
   - Carefully read the text.
   - Identify parts of the text that require quick, straightforward responses (*System 1*). Mark these sections with [sys1] and [end sys1].
   - Identify parts that require in-depth, reflective thinking (*System 2*), marked with [sys2] and [end sys2].

2. *Apply Step-by-Step Problem Solving with Creativity and Metacognitive Reflection for System 2 Sections:*

   *2.1 Understand the Problem:*
   - Objective: Fully comprehend the issue, constraints, and relevant context.
   - Reflection: "What do I understand about this issue? What might I be overlooking?"
   - Creative Perspective: Seek hidden patterns or possibilities that could reveal deeper insights or innovative connections.

   *2.2 Analyze the Information:*
   - Objective: Break down the problem logically.
   - Reflection: "Am I considering all factors? Are there any assumptions that need challenging?"
   - Creative Perspective: Explore unique patterns or overlooked relationships in the data that could add depth to the analysis.

   *2.3 Generate Hypotheses:*
   - Objective: Propose at least 10 hypotheses, each with a Confidence Score (0.0 to 1.0) and Creative Score (0.0 to 1.0), reflecting originality, surprise, and utility.
   - Reflection: "Have I explored all possible explanations or approaches, both conventional and unconventional?"
   - Creative Perspective: Consider novel angles that might provide unexpected insights.

   *2.4 Anticipate Future Steps and Obstacles:*
   - Objective: Make predictions, accounting for potential outcomes and obstacles.
   - Reflection: "What challenges might I face? Is my plan flexible for different scenarios?"
   - Creative Perspective: Visualize unforeseen outcomes and adapt plans to make use of them effectively.

   *2.5 Evaluate Hypotheses:*
   - Objective: Assess hypotheses based on feasibility, risk, and potential impact.
   - Evaluation: Refine Confidence and Creative Scores as needed.
   - Reflection: "Am I unbiased in my assessment? Which options fit best with the overall objectives?"
   - Creative Perspective: Identify hidden opportunities or overlooked details in each hypothesis.

   *2.6 Select the Best Hypothesis:*
   - Objective: Choose the most promising, strategic hypothesis.
   - Reflection: "Why does this hypothesis stand out? How does it uniquely address the issue?"
   - Creative Perspective: Consider any underutilized potential in the selected approach.

   *2.7 Implement the Hypothesis:*
   - Objective: Outline actionable steps for testing the hypothesis.
   - Reflection: "Is this plan practical? What resources or preparation are required?"
   - Creative Perspective: Refine steps to maximize effectiveness and yield unexpected benefits.

   *2.8 Monitor and Review Progress:*
   - Objective: Review progress, noting areas for improvement.
   - Reflection: "What’s working well? What could be improved?"
   - Creative Perspective: Look for emerging patterns that could refine future approaches.

   *2.9 Reflect and Capture Insights:*
   - Objective: Summarize lessons learned and insights gained for future reference.
   - Reflection: "What new understanding has emerged from this process?"
   - Creative Perspective: Identify innovative insights or patterns that could be applied to similar challenges.

3. *Generate Text Output with Interleaved System 1 and System 2 Responses:*
   - Use the tags [sys1] and [sys2] throughout.
   - Aim for a lengthier, detailed response. Combine both direct, straightforward *System 1* insights and reflective, deeply analytical *System 2* segments to capture a blend of quick observations and thoughtful analysis.

---

### *Example Input Text:*

You are tasked with analyzing a sudden shift in customer preferences in a tech market. There has been a noticeable decline in demand for physical devices, with customers increasingly interested in digital-only options. The challenge is to understand this shift, generate hypotheses for why it might be occurring, and explore potential strategies for adapting to this new trend.

---

### *Processed Output with System 1 and System 2 Thinking:*

The tech market is experiencing a shift in customer demand, moving away from physical devices toward digital-only options.

[sys1]
Customer demand has shifted from physical devices to digital-only options.
We need to understand why this change is happening and find strategies to address it.
Key factors may include cost, convenience, and technological trends.
[end sys1]

[sys2]
**2.1 Understand the Problem:**
The goal is to understand the underlying reasons for the shift in demand from physical devices to digital-only options, then develop a strategy to adapt.

*Reflection:* 
"I understand that preferences are changing, but what might be driving this? Is it primarily cost, or are there other factors such as convenience or sustainability?"

*Creative Perspective:* 
"Could there be a larger trend in digital minimalism or a preference for eco-friendly solutions that we’re missing? What unseen motivations might explain this shift?"

**2.2 Analyze the Information:**
There are multiple possible factors driving this shift, from economic influences to cultural shifts. It’s essential to isolate each factor and understand its impact.

*Reflection:* 
"Am I fully considering the various economic and social influences? Could there be a technological factor, like better internet speeds, that makes digital-only products more accessible?"

*Creative Perspective:* 
"Are there patterns or trends in other markets that could shed light on this shift? Could this be part of a larger trend toward virtual experiences?"

**2.3 Generate Hypotheses:**
1. Customers prefer digital options due to lower costs. (Confidence: 0.8, Creative: 0.4)
2. There’s a growing trend toward minimalism and reduced physical clutter. (Confidence: 0.7, Creative: 0.7)
3. Digital products offer greater flexibility and ease of use. (Confidence: 0.6, Creative: 0.6)
4. Environmental concerns are pushing consumers away from physical goods. (Confidence: 0.6, Creative: 0.8)
5. Advances in tech make digital-only options more functional. (Confidence: 0.8, Creative: 0.5)
6. Pandemic-era remote work increased demand for digital solutions. (Confidence: 0.7, Creative: 0.6)
7. Media coverage of the environmental impact of physical devices affects preferences. (Confidence: 0.5, Creative: 0.7)
8. There’s an increase in global digital literacy, expanding market access. (Confidence: 0.6, Creative: 0.6)
9. Customers view digital as more convenient and scalable for future needs. (Confidence: 0.7, Creative: 0.5)
10. Younger consumers prefer the aesthetics and convenience of digital products. (Confidence: 0.6, Creative: 0.6)

*Reflection:* 
"Have I considered all possible influences? Are there any surprising factors that could explain this shift?"

*Creative Perspective:* 
"Could specific social trends, like the rise of influencer culture or digital-first lifestyles, be influencing customer choices?"

**2.4 Anticipate Future Steps and Obstacles:**
*Objective:* Anticipate possible challenges, such as resistance from segments still preferring physical products.

*Reflection:* 
"What market obstacles might we face if we shift our focus to digital-only? Are there sub-segments that still prioritize physical products?"

*Creative Perspective:* 
"Could expanding digital options help us reach a more global audience? Are there emerging trends that we could leverage in our strategy?"

[end sys2]

[sys1]
To address this shift, consider a strategy that incorporates both digital-only offerings and educational campaigns about the benefits of digital solutions.
Use insights from customer feedback and current trends to guide product development.
Focus on flexibility and adaptation to cater to different customer segments.
[end sys1]


Neovasc soars as mitral valves head to Europe

Since December 1 shares in mitral valve group Neovasc are up 340%. A lucrative deal with Boston Scientific last week caused the stock to pop, but the fact that this deal excluded Neovasc’s flagship technology, the Tiara valve, and that new clinical data on Tiara are promising, pushed the shares up a further 70% yesterday.

This climb in value is pretty large considering the earliness of the data. The new results are from a pilot study in 30 patients, and with other transcatheter mitral technologies more advanced (see table), shareholders might be a little too enthusiastic.

Neovasc’s feasibility study, Tiara-1, is to assess the device’s safety in 30 patients with severe symptomatic mitral regurgitation. So far 22 patients have been treated with a technical success rate of 86%. In all 19 patients with technically successful implantations, paravalvular leak levels were reported as mild, trace or absent.

Sparkling

The all cause 30-day mortality rate so far is 15.7%. But this is only part of the primary endpoint, a composite of all-cause mortality and major adverse events, defined as disabling stroke, heart attack, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention.

There have been no reported adverse events related to the valve performance. Neovasc said that no device performance issues have observed with Tiara in any patient follow-up. However, analysts from Evercore ISI point out that there have been three cases of device malposition and three cases that were converted to open surgery in Tiara-1, and wrote that they were “unsure if this is a design issue”.

The trial is being conducted in very ill patients: those with NYHA Class III and IV heart failure. Around 26% of them had left ventricular ejection fraction (LVEF) of less than 30% – less than a third of the blood in these patients’ left ventricles was being pumped out of the chamber with each heartbeat. Medical consensus is that LVEF needs to be above 30% for transcatheter mitral valve procedures.

Race to Europe

No transcatheter valve replacement devices are approved yet anywhere in the world, and as is usual in medtech, European CE mark is the first target.

A 115-patient CE mark approval study of Tiara is due to start early next year. But here Neovasc is likely to trail at least two other technologies.

The European approval trial of Edwards Lifesciences’ CardiAQ valve is due to conclude in October 2017 and that for Abbott’s Tendyne product in May 2018. Both these companies acquired their valves by buying the companies that initially developed them – the same is true for Medtronic’s Twelve device, which has not yet reached the pivotal stage.

Selected active transcatheter mitral valve trials

Company

Device

Trial description

Primary completion date

Trial ID

Edwards Lifesciences

CardiAQ

Relief: Phase I/II, Europe and Canada, 200 patients *

October 2017

NCT02722551

Edwards Lifesciences

CardiAQ

Phase I, US, 28 patients

December 2016

NCT02718001

Abbott Laboratories

Tendyne

US, Europe and Australia, 110 patients *

May 2018

NCT02321514

Neovasc

Tiara

Tiara II: Europe, 115 patients *

Unknown; trial starts Q1 2017

-

Neovasc

Tiara

Tiara I: US, Europe and Canada, 30 patients

August 2017

NCT02276547

Medtronic

Twelve

Europe, 10 patients

July 2017

NCT02428010

* CE mark approval trials

Neovasc is one of the few remaining independent mitral valve companies. And it has recently narrowed its focus, selling its biotissue business to Boston last week; Tiara is almost the only thing it has left.

This deal was reminiscent of the one signed by Edwards Lifesciences a few days earlier, in which it bought all the assets of Valtech Cardio except its mitral valve, Cardiovalve, for $340m (Edwards gets everything but the valve, November 29, 2016). Cardiovalve does not appear to be in any active clinical trials, however, and in any case Edwards already has CardiAQ.

But transcatheter mitral valve replacement is forecast to take off in a huge way, with Leerink analysts saying the addressable market is worth $9bn. Even if Neovasc’s technology is third to the European market it might still be worth having. That said, potential acquirers – and it is perhaps of note that Boston is the only major CV company without a horse in the mitral race – might wish to wait until the full data from Tiara-I are available.