This document discusses the need for medical device companies to conduct deep due diligence when assessing new products given the evolving U.S. healthcare system's new focus on comparative and economic effectiveness. It outlines key clinical and economic questions that must be answered through compelling data to demonstrate improved outcomes and reduced societal costs. It differentiates between "me too" products that need prove parity and "innovative" products that could see exceptional opportunity but require rigorous studies. It recommends connecting with clinical and administrative communities and developing cost models to realistically assess new products under emerging public policies. External support from consultants is also advised.
Consortium metrics discussion with IOM Drug ForumMark David Lim
Presentation made to the IOM Forum on Drug Discovery, Development, and Translation to explore the possibility of metrics that evaluate the performance of biomedical research consortia
Presentation on the planned cost analysis of the NEAIC intervention by Robin Clark, PhD. (Presented at the annual meeting of the New England Asthma Innovations Collaborative, June 13, 2013, Shrewbury, MA)
Consortium metrics discussion with IOM Drug ForumMark David Lim
Presentation made to the IOM Forum on Drug Discovery, Development, and Translation to explore the possibility of metrics that evaluate the performance of biomedical research consortia
Presentation on the planned cost analysis of the NEAIC intervention by Robin Clark, PhD. (Presented at the annual meeting of the New England Asthma Innovations Collaborative, June 13, 2013, Shrewbury, MA)
David Kniaz (Merck) gives an overview of this potential Pistoia Alliance working group during the "Dragons' Den" session at the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Integrating Mobile Health into Product Development - OMTEC 2017April Bright
This presentation focuses on consumer trends and engagement along with ideas for integrating mobile health into product development and sales and marketing.
The Physician Value Index. A Tool for Effective Physician Integration. pscisolutions
Discover a new way to measure physician performance, and align physicians in context with patient satisfaction, quality-of-care measures and overall hospital financial performance.
David Kniaz (Merck) gives an overview of this potential Pistoia Alliance working group during the "Dragons' Den" session at the Pistoia Alliance Conference in Boston, MA, on April 24, 2012.
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Integrating Mobile Health into Product Development - OMTEC 2017April Bright
This presentation focuses on consumer trends and engagement along with ideas for integrating mobile health into product development and sales and marketing.
The Physician Value Index. A Tool for Effective Physician Integration. pscisolutions
Discover a new way to measure physician performance, and align physicians in context with patient satisfaction, quality-of-care measures and overall hospital financial performance.
James Dias, CEO, and Lucas Dailey, Senior User Experience Designer, will present a workshop, “Designing connected care solutions at the intersection of medicine and finance” on Saturday, September 6th from 2:20-3:50 PM PDT.
The workshop will explore how the business of performance-based healthcare requires a balance between giving patients the best possible quality outcomes and doing it in a cost effective manner. This emphasis on value-driven medicine is producing the opportunity for new technology solutions that address both care and costs. Designing effective solutions for “Connected Care” requires an interdisciplinary approach that brings together the disparate fields of healthcare economics, patient engagement, and digital technology.
Success Factors and Failure Points in Metabolic Product Launches Report SummaryBest Practices
Biopharmaceutical companies invest large amount of resources to develop and launch new products for metabolic therapeutic areas. However, the complexity of a new metabolic product launch is compounded by the many pitfalls that are part of the market-entry landscape.
Best Practices
®, LLC undertook this research to showcase current and future risk levels for various pitfalls across critical launch fronts that can derail a new metabolic product. Pharmaceutical launch executives can use this study to better understand the potential pitfalls and stumbling blocks that they'll have to navigate as part of a new metabolic product entering the market.
Study Overview–-
This study explores the executive insights, best practices and lessons learned to avoid common pitfalls while launching a new metabolic product into market.
About the Benchmark Class -
Forty four executives from 38 leading companies including Abbott, Amgen, Baxter, Bayer, Eisai, GlaxoSmithKline, Merck, Novartis, and Roche participated in this study. Majority of the respondents were at vice president or director level.
Section 1: Study Background --
Reviews the study background, the research approach, methodology, participant demographics, the benchmark class and key findings.
Section 2: Topical chapters --
Outlines valuable insights and findings from the study that includes pitfalls & stumbling blocks, lessons learned and best practices and future changes. Pitfalls chapter reviews current and future risk levels for these metabolic launch factors: product shaping, market shaping, physician, patient, payer, internal and regulatory.
Buisines model innovation - Is Healthcare falling behind?Pamela Spence
However excellent the traditional R&D innovation model in Big Pharma and Life Sciences may be why is their a lack of 'innovation spirit' across Healthcare industry to meet the and really harness the opportunity that Digital Creates. We debate and examine a route through for the Industry and the challenges it faces
The Business Case for QualityDecision making in todays health car.docxanhcrowley
The Business Case for Quality
Decision making in today's health care organizations requires a continuous balancing act, often involving tradeoffs to meet various clinical and business needs. For decisions related to quality, it is especially important to be able to provide a sound rationale for the choices that are made.
To prepare for this Discussion:
Bring to mind a specific quality or safety challenge that might be encountered in a health care organization (choose a type of organization that is of particular interest to you).
Review the information presented in the Learning Resources, including the "Making the Business Case for Quality Management" section on pages 128–141 in Medical Quality Management.
Must use this artcile. I will post below.
Article: Leatherman, S., Berwick, D., Iles, D., Lewin, L. S., et al. (2003). The business case for quality: Case studies and an analysis. Health Affairs, 22(2), 17–30. Retrieved from the Walden Library databases. ( ARTICLE BELOW - MUST USE)
Consider how and why you would suggest an organization address this challenge. Examine the following considerations, as well as others that would inform your response:
What are the driving forces or most compelling reasons for addressing this challenge?
How might financial constraints impact this situation?
What other resources might be limited within the organization? How could these resource constraints influence this situation?
What role might pay-for-performance play?
How could the short- and long-term financial outcomes of this situation be assessed? How would the return on investment be determined?
Who are the key stakeholders that would need to be included or considered in this decision?
What are the expected benefits? What unanticipated consequences might occur?
Note: You may find it helpful to preview the Application Assignment and use this Discussion to inform your focus for that assignment.
Post by Day 4 a response to the following:
Identify the quality or safety challenge you are addressing in the first line of your posting.
Briefly describe the quality or safety challenge.
Explain how and why you would suggest an organization address this challenge. Present a succinct analysis of three or more business considerations that inform your response.
ARTICLE BELOW - MUST USE
The business case for quality: Case studies and an analysis
Leatherman, Sheila; Berwick, Donald; Iles, Debra; Lewin, Lawrence S; et al. Health Affairs22.2 (Mar/Apr 2003): 17-30.
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Abstract (summary)
Translate Abstract
The financial implications of implementing quality improvements are often poorly understood. This paper examines four cases - management of high-cost pharmaceuticals, diabetes management, smoking cessation, and wellness programs in the workplace - to understand the financial and clinical implications of improving care. I.
mHealth Israel_Managing the Barriers to Customer Adoption_Lisa Prasad, Henry ...Levi Shapiro
Managing the Barriers to Customer Adoption- Presentation by Lisa Prasad, Managing Director, International, Henry Ford Innovation Institute at the Henry Ford Health System. Background about Provider efforts toward innovation, including status of Digital Transformation, impediments and barriers to adoption, persuading doctors / health care professionals, workflow challenges, activation constraints, procurement cycles, costs, IT integration and security, role of incumbents and practitioners, validation plans, payer inefficiencies,
Overcoming Challenges in implementation of Quality Process in Healthcare By D...Healthcare consultant
Research has shown that 95 percent of diets fail over the long term. Oddly enough, various studies show that 60 to 80 percent of major change initiatives also fail. In both cases, it is certainly not for lack of good intentions. For a person who has been on a successful diet, it is frustrating to see those pounds sneak back on. And it is just as frustrating for an organization which has implemented a major improvement initiative to have costs, errors or inefficiencies creep in again. This is the short-term-gain, long-term-wane syndrome.
Modern Healthcare 2014 Strategic Marketing Conference SlidesModern Healthcare
Thank you for joining us at the inaugural Strategic Marketing Conference, which took place Sept. 23 and 24 in Chicago. We hope you enjoyed the education, engaging in discussions and extending your professional networks.
Click here to view the program guide and agenda from the Strategic Marketing Conference:
http://www.modernhealthcare.com/assets/pdf/CH96416919.PDF
About the Conference:
Modern Healthcare's Strategic Marketing Conference is a two day educational conference that was held September 23 and 24, 2014 at the Hyatt Regency Chicago.
This year’s conference presented thought leaders in healthcare marketing who helped to guide healthcare marketers, focusing on consumer-driven, reform-led and economically necessary challenges. Modern Healthcare's Strategic Marketing Conference is an opportunity for healthcare marketing executives on the provider and supplier side to interact and collaborate on best practices. Throughout two days, the conference provides a unique opportunity for healthcare marketing executives and agencies representing providers, insurers, suppliers and advocacy groups to interact and collaborate on best practices.
1. Addressing the New Realities of
Tomorrow’s Healthcare Environment
Deep Due Diligence for
New-Product Assessment
2. Contents
A New Focus 3
The Rationale 4
Answering the Clinical Questions 5
Answering the Economics Questions 6
Case #1: “Me Too” Product 7
Case #2: “Innovative” Product 8
Steps and Resources Required 9
Need Help? 10
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3. A New Focus
• Accurately assessing the opportunity presented by a
prospective new product has always been important
• Now, as the U.S. healthcare system evolves, a new
focus will become critically important to suppliers:
Comparative Effectiveness
– This means your new product must be at least as clinically
effective as the prevailing method(s), preferably more so
– But this also means your new product must be at least as
economically effective, preferably more so
– If you fail either of these future tests, your new product
won’t be cleared to market or won’t be paid for
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4. The Rationale
• This new focus is being driven by a pending new
emphasis on procedural value:
Clinical Performance + Societal Cost
• As a supplier you will be required to demonstrate…
– Improved clinical outcomes, and
– Reduced societal costs
… by means of compelling quantitative data,
perhaps including the findings of clinical trials
• Details are just now being formulated, but you ignore
this pending U.S. government initiative at your peril
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5. Answering the Clinical Questions
• Who will use the product, and for precisely what
purpose? Can you access and convince the user?
• Will it improve clinical outcomes? Can you prove it?
• Who will benefit? Patient? Practitioner?
Institution? Society?
• Is the procedural transition manageable? Can you
overcome “medical momentum”?
• Can you reduce medical error and/or reduce
incorrect diagnoses? What evidence do you have?
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6. Answering the Economics Questions
• What are the real net costs to the institution,
practitioner, insurer, patient, and society? Are any of
these costs (especially societal costs) less than the
prevailing accepted alternative(s)?
• Are your cost models credible and defensible? Can
your projection of societal costs survive scrutiny?
• What changes in insurer reimbursement policies are
in store? Can your new product actually influence
these changes?
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7. Case #1: “Me Too” Product
• Questions can be answered rather easily, as parity
with prevailing method(s) is likely
• Commercial opportunity and supplier impact likely to
be marginal (but perhaps tactically important)
• Significant risk of reduced coverage or
reimbursement amounts if an “innovative”
alternative product becomes available
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8. Case #2: “Innovative” Product
• Definition: An “innovative” product yields better
clinical and economic outcomes for society
• Questions will be difficult to answer authoritatively,
as rigorous studies may be required
• Commercial opportunity and supplier impact likely to
be exceptional and strategically important
• Little risk of reduced coverage or reimbursement
amounts
– More generous reimbursements may be achievable
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9. Steps and Resources Required
1. Awareness and accurate interpretation of the
moving target that is U.S. healthcare public policy
2. Familiarity and experience with a wide variety of
medtech markets and product classes
3. Connections to relevant clinical communities to
initiate in-depth dialogs with physicians for
assessment of a product’s clinical benefits
4. Awareness of healthcare cost structures and
connections to administrative communities for the
development of rigorous societal cost models
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10. Need Help?
• Trilogy Associates can support your deep due
diligence work in realistically assessing the promise
of a planned new product
• We can efficiently address all these and other
requirements consistent with the new realities of
tomorrow’s healthcare environment
• Contact:
Joe Kalinowski
919.533.6285
jk@trilogyassociates.com
http://trilogyassociates.com
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