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Medical Device Development Lifecycle

The document discusses key considerations for developing medical devices with a global market strategy in mind. It outlines common mistakes made during development like poor reimbursement planning, lack of human factors research, and unclear regulatory pathways. It emphasizes the importance of bringing together all development disciplines like regulatory, compliance, testing, and reimbursement in a unified strategy from the beginning. Finally, it discusses best practices like working closely with regulatory agencies early, having a platform for evolution, and maintaining strong communication across functions and stakeholders.

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Experience the Difference with the MRO™ Approach Northwood, OH | Minneapolis, MN | Irvine, CA | Sunnyvale, CA | Frankfurt, Germany | Yorkshire, England | Lyon, France | Shanghai, China | Tokyo, Japan
2 Thinking Globally During Medical Device Development: Accelerating Products to International Markets Tim Blair Director Global Business Development Seth J. Goldenberg, Ph.D. Senior Principal Scientist
3 Expectations » Healthcare economy today » Basics of the product development lifecycle » Thinking globally when developing your “get to market strategy” » Bringing development disciplines together in a unified, strategic fashion » Considerations medical device developers should have in moving devices forward » Avoiding “unnecessary” failure
4 Expectations » Healthcare economy today
5 Healthcare Trends (Innovation) » MedTech growth ~5% CAGR reaching $500BB in the next 10 years » Revenue growth in MedTech (5%) will outperform Pharma (3.8%) 2012-18 » China MedTech growth is ~20% (Consumption and Production) » LATAM MedTech growth is ~10% (Brazil and Argentina ~20%) » IVDs expected to lead MedTech growth with global revenues ~$60BB, followed by Cardiology and Diagnostic imaging » PMA “like” devices available in Europe an avg of 43 months before being made available in US markets – changing trend? » First time PMAs decreased 5% in 2012 and a similar decrease in 2014 (Is this an innovation pattern?) » Avg. cost > $100MM and 8 years to get a PMA to market
6 Healthcare Trends (Innovation) » Hospital utilization for devices are trending down » Device revenue / margins continue to get squeezed (Utilization, Reimbursements, Taxes, Time to Market) » MedTech spending in RA, QA, CA growing ~3X market growth » MedTech R&D spending will grow 3.9% / year to reach $26.7BB by 2018 – but slowing relative to CAGR » M&A deal value fell 14% in 2013; deal count dropped 15% » Recent Mega Deals 2014-5 indicate what?
7 Healthcare Trends (Innovation) » Investor $ fell 14% in 2012 to $3.8BB; expanded slightly by the end of 2013 » Nat’l Venture Capital Association estimates 25-30% of venture backed businesses fail completely » Wall Street Journal – of 10 VC backed deals 3-4 fail completely; 3-4 return original investment; 1-2 produce substantial returns » Define failure? “If failure is defined as failing to see the project return on investment (specific revenue growth rate, date, or break even) then >95% of start ups fail.” Shikhar Ghosh
8 So what? » The MedTech Industry will see stable growth, but struggling to maintain historical profits » Device Makers have to find growth (M&A, Operational Efficiencies, Innovation, New Markets – Mega Deals make sense) » Device Makers have to control costs more than ever » Device Makers will be seeking new innovation models and partners to market their products » Device Makers have to maintain compliance and acceptance in current markets which is only getting more challenging
9 A Medical Device - Defined » A medical device is defined within the Food, Drug, and Cosmetic Act as:  "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes"
10 A Medical Device - Defined » A medical device is defined within the Food, Drug, and Cosmetic Act as:  "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." is not a drug.”
11 FDA Classifications Lowest risk classification. FDA Review is not typically required. Usually 510(k) exempt. • Bandages • Many surgical tools FDA clearance is typically needed via FDA 510(k) process. Applicant must show “Substantial Equivalence” to a previously cleared “Predicate Device” • Intravascular guide wires • X-ray machines Highest risk classification. Approval is usually obtained through FDA’s Premarket Approval (PMA) process • Pacemakers • Heart valves See NAMSA’s whitepapers for more information.
12 CE Mark Classifications Lowest risk classification. Non-sterile and /or non- measuring function; No Notified Body involvement Class IIa - Manufacturing systems audit Class IIb - Manufacturing & product design audit (Technical File) Highest risk classification. Manufacturing & Design Dossier audit See “The Medical Device Regulations” by Kathe Clark for detailed information.
13 Variability in Medical Device Classification » Different device classification can significantly impact path for approval » For Example:  A device in the US could be a drug in the EU or other foreign markets  A 510(k) orthopedic device in the US is frequently a Class III in China and will require local clinical data  Mexico and Chile fast track FDA and Canadian approvals » Understanding the differences is optimal to planning appropriately for your launch - ensuring all testing, regulatory, quality, reimbursement, and clinical requirements are aligned to the commercial promises is critical
14 Expectations » Basics of the product development lifecycle » Thinking globally when developing your “get to market strategy”
15 Common Mistakes in Medical Device Development » Technology not “disruptive” enough – actual better put “technology did not make industry take notice” » Me too product that failed to understand GPO or Hospital Network objectives » Poor reimbursement planning – lack of code, coverage, or payment may prevent funding and WILL impact adoption in the marketplace » Failed to address the Health Economics of today » Failed to employ Human Factors Research » Undefined regulatory pathway – poor indication strategy (idea is to focus on starting smart) » Unclear Global Market Strategy
16 Common Mistakes in Medical Device Development » Underdeveloped time and cost analysis – milestone strategies were poorly established and poorly communicated » Ideas, IFUs, owner’s manuals aren’t accepted or understood in the chosen markets » Failure to hire the right team, overcoming turnover, over paying executives, managing conflict, and a recognition that outsourced specialists are likely better, faster, and cheaper (FTEs are often the biggest line item in a budget – why?) » Engineering and Manufacturing misaligned or incomplete (GMP)
17 So what? » Devices fail to reach their objectives for many reasons; a singular strategy on its own is not enough in getting to revenue – tomorrow’s innovators will have to do more with less – we need to innovate innovation » Today’s “buyers” of innovation have changed and/or need to be identified early » An early, well defined global strategy is critical to success  Customized for speed  Optimized to reduce risk and take advantage of market intelligence  Global knowhow and communication
18 Ideas for Development Success » Unmet needs need a defined “get to market strategy” that includes regulatory, compliance, testing, reimbursement, financials, and other disciplines  Speed to market relies on this harmonization » Have solid and expanding IP – even blocking IP » Work with FDA (and other notified bodies) early and often (Pre submission meetings are free) » Have a platform, an evolution » Have passion, take beachhead everyday
19 Expectations » Bringing development disciplines together in a unified, organized, strategic fashion
20 Product Development Process Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market Aligning your Get to Market Strategy Across All Phases and Disciplines is Critical to Success
21 Medical Device Development Process » A strong team who understands the process is critical to investors or project leaders » Communication across the team is critical to success
22 Note: Product Development is not a single event. Developing a device is a process that evolves, goes in circles, and rarely has an endpoint that resembles the draft document. It’s not linear and there is no definition for the development process. The development process is messy and there are many tradeoffs along the way. Factors: How are you communicating the process? Who is the owner of the process? What are the assumptions / risks? What downstream disciplines can you introduce early? Medical Device Development Process
23 Communication: Developing a Path to Market » Great ideas must have a strong documented vision amongst all stakeholders
24 Owner of the Development Process » Managers of Innovation – the owner of the process  Large Industry – Product Manager, a person who often has one foot in engineering and the other foot in marketing; owner might be higher to the P&L holder  Start Up – President or Founder / Inventor, a person with an idea to address a market need » Responsibility of this owner / manager  Build the “strategic marketing” plan, communicate the plan, manage the resources, manage the costs, and manage the risks
25 Market Strategy Note: Despite doomsday scenarios, the MedTech space is expected to reach > $500BB in the next 10 years, up from $270BB in the current decade Differentiation Reimbursement Clinical Evidence
26 Market Strategy – Your Story, Your Value » Market evaluation » What else?  Alignment with regulatory, testing and clinical plans to provide the right data with optimal speed  Sound post market clinical data should be used to differentiate you in the market – Health Economics is here to stay  “Clinical data is the number one driver of a company / project’s value”
27 Incremental Products Market Strategy Decision Define • V1.0 Refine • V2.0 Extend • V3.0 Disruptive Products Unmet Medical Need Technology Leap KOL Demand Product Approval
28 Example Products » Incremental  Infusion Lines  Catheters  Needle Protection  PICC lines  Syringes » Disruptive  Venous Stents  Mini Pacemakers  Robotic Surgery  Electronic Medical Records  Phone Apps Note: Both types of products face similar challenges, although a few exceptions where disruptive products have additional challenges
29 Careful Evaluation of Market Opportunities » In depth analysis of market opportunities in specific sectors / therapies is crucial » Over estimation of market size can lead to not reaching sales goals or to imperfect business and legal decisions downstream
30 China » Rise in GDP driving healthcare growth » Driven by government initiatives » Average heath expenditure is very low (~$200), yet higher in urban centers that have better insurance systems Source: EvaluateMedtech 0 1000 2000 3000 4000 5000 6000 US$ GDP & Healthcare Spend per Capita (Current US$) China Health Care Expenditure China GDP
31 0 2000 4000 6000 8000 10000 12000 14000 US$ GDP & Healthcare Spend per Capita (Current US$) Brazil Healthcare Expenditure Brazil GDP Brazil » Average heath expenditure is ~$900 per person Source: EvaluateMedtech
32 So what? » The device development process is challenging  Iterative  More than just an unmet need or IP » The global medical device market is complex  Filled with opportunity with the right know how  Minimize mistakes with the same know how  Stay align with those who know
33 Concept / Feasibility Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market
34 Concept / Unmet need: Is my idea any good? Validation » Feasibility and Effectiveness (Pre-clinical)  Does the concept do what we thought it would do?  Form, fit, function (Bench, Animal, Anatomical) » What do I need to change or modify?  Designs  Marketing Strategy  Regulatory Strategy » Beginnings of Safety (should it align with the clinical study?) » Beginnings of Indications » Beginnings of Sterilization » Beginnings of Packaging » Beginnings of Manufacturing
35 Unmet Needs Design Input Design Process Design Output Medical Device Early Design & Development: Verification & Validation
36 Global Strategic Considerations » What are global regulatory / testing requirements for my product?  Don’t expect to go to China for an orthopedic product without clinical data  Many markets outside of US/EU prefer testing to risk assessments Testing Labeling/IFU Clinical
37 Regulatory Strategy » Early decisions impact all decisions downstream » Frequent regulatory feedback can speed approval Regulatory Preclinical / Clinical Prototype / Design Concept
38 Reimbursement: Incremental Product Considerations Coverage Whether a service or product fits the legal definition of a medically necessary covered benefit Coding “Fit” of a new procedure into an existing code description Payment Whether the procedure code assignment to a DRG group results in adequate payment Market opportunity / reimbursement processes » Which markets present the best opportunity for your specific indication? Regulatory path and indications for use aligned? » What are the coverage, coding, and payment processes and related timelines in each market? » Which markets are the easiest and fastest to receive reimbursement? Revenue, Data? » How healthcare is delivered in China may be significantly different than US/EU?
39 Reimbursement + Disruptive Product Considerations: » Market opportunities / reimbursement processes  Does the procedure fit into an existing code?  Can KOL publications and clinical evidence support a new CPT code? » Clinical usage and economic data  What is the evidence needed to support approval and premium payment? US & EU are quite different  Does the economic premise of your product hold up in a foreign context?
40 Quality/Compliance » Quality system compliance often the most time consuming and complex component of device registration » Development must comply with all quality standards  Proper Design Controls / Process Controls  Proper qualification of suppliers with proper documentation  Review of all local and international requirements » Most quality systems are too large or non-existent » Think about how your quality manual will integrate with your manufacturing strategy as you prepare for testing and clinical activities
41 Quality/Compliance Manufacturing Quality System
42 Concept / Feasibility Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market » Beginning of the Process  Idea / unmet need developed  Early Designs and Validation Process, iterative  R&D Bench and Animal models  Regulatory Strategy, global discussion with regulators early and often  Reimbursement Strategy, think early and often  Quality / Compliance, be Goldilocks
43 Design Validation / Preclinical Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market
44 Testing » Safety models » Efficacy models – understand your IFU related to predicates » Validation of Safety » Understand regulatory guidance documents » If entering multiple markets, consider testing gap analysis  China uses older versions of ISO standards and has “Chinese National Standards” that could differ from US/EU or MHLW requirements  Additional test group in parallel could provide significant savings if alternative is complete repeat of testing to enter global markets
45 Testing Disruptive Product Considerations » Alignment of preclinical data with regulatory and clinical experts will greatly expedite time to market » Strategic consideration should be given to larger preclinical data harmonized with smaller clinical data – FDA is open minded, other markets may not be » Strategic testing decisions – the whole product or test the components? » Discussion/Education with global testing groups and foreign regulatory experts are key to success if going abroad
46 Design Validation / Preclinical Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market » Having a global preclinical / testing plan that is harmonized with your regulatory, reimbursement, and clinical plans will:  Reduce your risk  Optimize your products for the right pre market or post market studies  Optimize your products for the right markets (more than just one market with incremental costs)  Reduce unnecessary testing or research
47 Clinical Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market
48 Clinical » Validation of Safety and Efficacy work » Typically required by regulators for disruptive products, but not always for incremental products » Global site selection and patient selection criteria are critical » During clinical trial design, reimbursement strategy and “motivation” of KOLs / Sites must be considered » Understand foreign requirements that best treatment after the study to be provided at $0 for chronic indications / or sponsor requirements for treatment costs beyond the standard of care
49 Clinical » Keep costs down on clinical trials and consider publication planning in supporting commercial goals but be careful – don’t sacrifice time or approval » Is additional data worthwhile to differentiate, or should this be a post market strategy? » Health Outcomes & Health Economics are here to stay Note: Clinical data is the number one drive of a company’s value. Valid data in today’s healthcare market is critical in getting to market and thriving in the market even if not required for regulatory approval.
50 Clinical Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market » Clinical data is #1  Watch the stock tickers  Watch the big exit start ups » Maximize the clinical phase – but don’t create unnecessary red flags by trying to do more than is required (marketing and clinical are different things) » Seek strategies (global sites, community hospitals) that impact enrollment and study execution over big name KOLs and Institutes
51 Market Approval Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market
52 Regulatory Submission » Submitting the dossier is just the beginning » Several rounds of discussion may be required before acceptance » Regulations on response times are constantly changing (Brazil and EU are changing) » Understand the global agency timetables to reduce risk / optimize your get to market strategy » Is distribution tied to your foreign registration?
53 Regulatory Approval Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market So Your Device is Approved Now What?
54 Manufacturing Strategy » Begin scaling your manufacturing strategy  Contract manufacturer OR Equipment in house (decision likely made during the feasibility stages)  Scale in step with Distribution Strategies » Optimization of the manufacturing process (still understanding GMP guidelines)  Stability  Process improvements  Compliant  Reproducibility  Document Controls  Product Accountability
55 Distribution Strategy » What is your strategy for commercial adoption? » Significant physician training & KOL development maybe required in international markets, particularly for disruptive products » Conference and Tradeshow adoption strategies
56 Post-Market » Ongoing clinical evaluation to further validate patient safety, product efficacy » Collect data to differentiate your technology and pursue product improvement » Collect marketing data to publish and promote product to KOLs » Sales Force Training (direct or indirect) » Physician Training, particularly for first to market & disruptive products
57 Product Development in Summary » Failure to explore global market opportunities will lead to less than optimal results  Investors / Sr. Management want global strategy » Collaboration across product development life cycle is key to success, it’s not linear, seek partners who know » Alignment of regulatory, reimbursement, testing, quality, clinical, manufacturing, and distribution across the global market strategy is essential (too few companies have this mapped)  Time, cost, burn rates – don’t let the project die! Develop the right milestones for you and your investors » Convincing preclinical and clinical data, ideally linked to positive health outcomes is key to product adoption » No product is alike; regulatory bodies, reimbursement, testing guidelines and market conditions are constantly changing  Customized development strategies must be employed
58 Thank you NAMSA Headquarters 6750 Wales Road Northwood, OH 43619 USA Telephone: 866.666.9455 (toll free) +1 419.666.9455 (direct) +1 419.662.4386 (fax) info@namsa.com Tim Blair Director Global Business Development tblair@namsa.com Seth J. Goldenberg, Ph.D. Senior Principal Scientist sgoldenberg@namsa.com

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Medical Device Development Lifecycle

  • 1.
    Experience the Difference withthe MRO™ Approach Northwood, OH | Minneapolis, MN | Irvine, CA | Sunnyvale, CA | Frankfurt, Germany | Yorkshire, England | Lyon, France | Shanghai, China | Tokyo, Japan
  • 2.
    2 Thinking Globally During MedicalDevice Development: Accelerating Products to International Markets Tim Blair Director Global Business Development Seth J. Goldenberg, Ph.D. Senior Principal Scientist
  • 3.
    3 Expectations » Healthcare economytoday » Basics of the product development lifecycle » Thinking globally when developing your “get to market strategy” » Bringing development disciplines together in a unified, strategic fashion » Considerations medical device developers should have in moving devices forward » Avoiding “unnecessary” failure
  • 4.
  • 5.
    5 Healthcare Trends (Innovation) »MedTech growth ~5% CAGR reaching $500BB in the next 10 years » Revenue growth in MedTech (5%) will outperform Pharma (3.8%) 2012-18 » China MedTech growth is ~20% (Consumption and Production) » LATAM MedTech growth is ~10% (Brazil and Argentina ~20%) » IVDs expected to lead MedTech growth with global revenues ~$60BB, followed by Cardiology and Diagnostic imaging » PMA “like” devices available in Europe an avg of 43 months before being made available in US markets – changing trend? » First time PMAs decreased 5% in 2012 and a similar decrease in 2014 (Is this an innovation pattern?) » Avg. cost > $100MM and 8 years to get a PMA to market
  • 6.
    6 Healthcare Trends (Innovation) »Hospital utilization for devices are trending down » Device revenue / margins continue to get squeezed (Utilization, Reimbursements, Taxes, Time to Market) » MedTech spending in RA, QA, CA growing ~3X market growth » MedTech R&D spending will grow 3.9% / year to reach $26.7BB by 2018 – but slowing relative to CAGR » M&A deal value fell 14% in 2013; deal count dropped 15% » Recent Mega Deals 2014-5 indicate what?
  • 7.
    7 Healthcare Trends (Innovation) »Investor $ fell 14% in 2012 to $3.8BB; expanded slightly by the end of 2013 » Nat’l Venture Capital Association estimates 25-30% of venture backed businesses fail completely » Wall Street Journal – of 10 VC backed deals 3-4 fail completely; 3-4 return original investment; 1-2 produce substantial returns » Define failure? “If failure is defined as failing to see the project return on investment (specific revenue growth rate, date, or break even) then >95% of start ups fail.” Shikhar Ghosh
  • 8.
    8 So what? » TheMedTech Industry will see stable growth, but struggling to maintain historical profits » Device Makers have to find growth (M&A, Operational Efficiencies, Innovation, New Markets – Mega Deals make sense) » Device Makers have to control costs more than ever » Device Makers will be seeking new innovation models and partners to market their products » Device Makers have to maintain compliance and acceptance in current markets which is only getting more challenging
  • 9.
    9 A Medical Device- Defined » A medical device is defined within the Food, Drug, and Cosmetic Act as:  "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes"
  • 10.
    10 A Medical Device- Defined » A medical device is defined within the Food, Drug, and Cosmetic Act as:  "...an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." is not a drug.”
  • 11.
    11 FDA Classifications Lowest riskclassification. FDA Review is not typically required. Usually 510(k) exempt. • Bandages • Many surgical tools FDA clearance is typically needed via FDA 510(k) process. Applicant must show “Substantial Equivalence” to a previously cleared “Predicate Device” • Intravascular guide wires • X-ray machines Highest risk classification. Approval is usually obtained through FDA’s Premarket Approval (PMA) process • Pacemakers • Heart valves See NAMSA’s whitepapers for more information.
  • 12.
    12 CE Mark Classifications Lowestrisk classification. Non-sterile and /or non- measuring function; No Notified Body involvement Class IIa - Manufacturing systems audit Class IIb - Manufacturing & product design audit (Technical File) Highest risk classification. Manufacturing & Design Dossier audit See “The Medical Device Regulations” by Kathe Clark for detailed information.
  • 13.
    13 Variability in MedicalDevice Classification » Different device classification can significantly impact path for approval » For Example:  A device in the US could be a drug in the EU or other foreign markets  A 510(k) orthopedic device in the US is frequently a Class III in China and will require local clinical data  Mexico and Chile fast track FDA and Canadian approvals » Understanding the differences is optimal to planning appropriately for your launch - ensuring all testing, regulatory, quality, reimbursement, and clinical requirements are aligned to the commercial promises is critical
  • 14.
    14 Expectations » Basics ofthe product development lifecycle » Thinking globally when developing your “get to market strategy”
  • 15.
    15 Common Mistakes in MedicalDevice Development » Technology not “disruptive” enough – actual better put “technology did not make industry take notice” » Me too product that failed to understand GPO or Hospital Network objectives » Poor reimbursement planning – lack of code, coverage, or payment may prevent funding and WILL impact adoption in the marketplace » Failed to address the Health Economics of today » Failed to employ Human Factors Research » Undefined regulatory pathway – poor indication strategy (idea is to focus on starting smart) » Unclear Global Market Strategy
  • 16.
    16 Common Mistakes in MedicalDevice Development » Underdeveloped time and cost analysis – milestone strategies were poorly established and poorly communicated » Ideas, IFUs, owner’s manuals aren’t accepted or understood in the chosen markets » Failure to hire the right team, overcoming turnover, over paying executives, managing conflict, and a recognition that outsourced specialists are likely better, faster, and cheaper (FTEs are often the biggest line item in a budget – why?) » Engineering and Manufacturing misaligned or incomplete (GMP)
  • 17.
    17 So what? » Devicesfail to reach their objectives for many reasons; a singular strategy on its own is not enough in getting to revenue – tomorrow’s innovators will have to do more with less – we need to innovate innovation » Today’s “buyers” of innovation have changed and/or need to be identified early » An early, well defined global strategy is critical to success  Customized for speed  Optimized to reduce risk and take advantage of market intelligence  Global knowhow and communication
  • 18.
    18 Ideas for DevelopmentSuccess » Unmet needs need a defined “get to market strategy” that includes regulatory, compliance, testing, reimbursement, financials, and other disciplines  Speed to market relies on this harmonization » Have solid and expanding IP – even blocking IP » Work with FDA (and other notified bodies) early and often (Pre submission meetings are free) » Have a platform, an evolution » Have passion, take beachhead everyday
  • 19.
    19 Expectations » Bringing developmentdisciplines together in a unified, organized, strategic fashion
  • 20.
    20 Product Development Process Concept/Feasibility DesignValidation / Preclinical Clinical Market Approval Post-Market Aligning your Get to Market Strategy Across All Phases and Disciplines is Critical to Success
  • 21.
    21 Medical Device DevelopmentProcess » A strong team who understands the process is critical to investors or project leaders » Communication across the team is critical to success
  • 22.
    22 Note: Product Developmentis not a single event. Developing a device is a process that evolves, goes in circles, and rarely has an endpoint that resembles the draft document. It’s not linear and there is no definition for the development process. The development process is messy and there are many tradeoffs along the way. Factors: How are you communicating the process? Who is the owner of the process? What are the assumptions / risks? What downstream disciplines can you introduce early? Medical Device Development Process
  • 23.
    23 Communication: Developing aPath to Market » Great ideas must have a strong documented vision amongst all stakeholders
  • 24.
    24 Owner of theDevelopment Process » Managers of Innovation – the owner of the process  Large Industry – Product Manager, a person who often has one foot in engineering and the other foot in marketing; owner might be higher to the P&L holder  Start Up – President or Founder / Inventor, a person with an idea to address a market need » Responsibility of this owner / manager  Build the “strategic marketing” plan, communicate the plan, manage the resources, manage the costs, and manage the risks
  • 25.
    25 Market Strategy Note: Despitedoomsday scenarios, the MedTech space is expected to reach > $500BB in the next 10 years, up from $270BB in the current decade Differentiation Reimbursement Clinical Evidence
  • 26.
    26 Market Strategy –Your Story, Your Value » Market evaluation » What else?  Alignment with regulatory, testing and clinical plans to provide the right data with optimal speed  Sound post market clinical data should be used to differentiate you in the market – Health Economics is here to stay  “Clinical data is the number one driver of a company / project’s value”
  • 27.
    27 Incremental Products Market StrategyDecision Define • V1.0 Refine • V2.0 Extend • V3.0 Disruptive Products Unmet Medical Need Technology Leap KOL Demand Product Approval
  • 28.
    28 Example Products » Incremental Infusion Lines  Catheters  Needle Protection  PICC lines  Syringes » Disruptive  Venous Stents  Mini Pacemakers  Robotic Surgery  Electronic Medical Records  Phone Apps Note: Both types of products face similar challenges, although a few exceptions where disruptive products have additional challenges
  • 29.
    29 Careful Evaluation ofMarket Opportunities » In depth analysis of market opportunities in specific sectors / therapies is crucial » Over estimation of market size can lead to not reaching sales goals or to imperfect business and legal decisions downstream
  • 30.
    30 China » Rise inGDP driving healthcare growth » Driven by government initiatives » Average heath expenditure is very low (~$200), yet higher in urban centers that have better insurance systems Source: EvaluateMedtech 0 1000 2000 3000 4000 5000 6000 US$ GDP & Healthcare Spend per Capita (Current US$) China Health Care Expenditure China GDP
  • 31.
    31 0 2000 4000 6000 8000 10000 12000 14000 US$ GDP & HealthcareSpend per Capita (Current US$) Brazil Healthcare Expenditure Brazil GDP Brazil » Average heath expenditure is ~$900 per person Source: EvaluateMedtech
  • 32.
    32 So what? » Thedevice development process is challenging  Iterative  More than just an unmet need or IP » The global medical device market is complex  Filled with opportunity with the right know how  Minimize mistakes with the same know how  Stay align with those who know
  • 33.
    33 Concept / Feasibility Concept/Feasibility DesignValidation / Preclinical Clinical Market Approval Post-Market
  • 34.
    34 Concept / Unmetneed: Is my idea any good? Validation » Feasibility and Effectiveness (Pre-clinical)  Does the concept do what we thought it would do?  Form, fit, function (Bench, Animal, Anatomical) » What do I need to change or modify?  Designs  Marketing Strategy  Regulatory Strategy » Beginnings of Safety (should it align with the clinical study?) » Beginnings of Indications » Beginnings of Sterilization » Beginnings of Packaging » Beginnings of Manufacturing
  • 35.
  • 36.
    36 Global Strategic Considerations »What are global regulatory / testing requirements for my product?  Don’t expect to go to China for an orthopedic product without clinical data  Many markets outside of US/EU prefer testing to risk assessments Testing Labeling/IFU Clinical
  • 37.
    37 Regulatory Strategy » Earlydecisions impact all decisions downstream » Frequent regulatory feedback can speed approval Regulatory Preclinical / Clinical Prototype / Design Concept
  • 38.
    38 Reimbursement: Incremental Product Considerations Coverage Whethera service or product fits the legal definition of a medically necessary covered benefit Coding “Fit” of a new procedure into an existing code description Payment Whether the procedure code assignment to a DRG group results in adequate payment Market opportunity / reimbursement processes » Which markets present the best opportunity for your specific indication? Regulatory path and indications for use aligned? » What are the coverage, coding, and payment processes and related timelines in each market? » Which markets are the easiest and fastest to receive reimbursement? Revenue, Data? » How healthcare is delivered in China may be significantly different than US/EU?
  • 39.
    39 Reimbursement + Disruptive ProductConsiderations: » Market opportunities / reimbursement processes  Does the procedure fit into an existing code?  Can KOL publications and clinical evidence support a new CPT code? » Clinical usage and economic data  What is the evidence needed to support approval and premium payment? US & EU are quite different  Does the economic premise of your product hold up in a foreign context?
  • 40.
    40 Quality/Compliance » Quality systemcompliance often the most time consuming and complex component of device registration » Development must comply with all quality standards  Proper Design Controls / Process Controls  Proper qualification of suppliers with proper documentation  Review of all local and international requirements » Most quality systems are too large or non-existent » Think about how your quality manual will integrate with your manufacturing strategy as you prepare for testing and clinical activities
  • 41.
  • 42.
    42 Concept / Feasibility Concept/Feasibility DesignValidation / Preclinical Clinical Market Approval Post-Market » Beginning of the Process  Idea / unmet need developed  Early Designs and Validation Process, iterative  R&D Bench and Animal models  Regulatory Strategy, global discussion with regulators early and often  Reimbursement Strategy, think early and often  Quality / Compliance, be Goldilocks
  • 43.
    43 Design Validation /Preclinical Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market
  • 44.
    44 Testing » Safety models »Efficacy models – understand your IFU related to predicates » Validation of Safety » Understand regulatory guidance documents » If entering multiple markets, consider testing gap analysis  China uses older versions of ISO standards and has “Chinese National Standards” that could differ from US/EU or MHLW requirements  Additional test group in parallel could provide significant savings if alternative is complete repeat of testing to enter global markets
  • 45.
    45 Testing Disruptive ProductConsiderations » Alignment of preclinical data with regulatory and clinical experts will greatly expedite time to market » Strategic consideration should be given to larger preclinical data harmonized with smaller clinical data – FDA is open minded, other markets may not be » Strategic testing decisions – the whole product or test the components? » Discussion/Education with global testing groups and foreign regulatory experts are key to success if going abroad
  • 46.
    46 Design Validation /Preclinical Concept/Feasibility Design Validation / Preclinical Clinical Market Approval Post-Market » Having a global preclinical / testing plan that is harmonized with your regulatory, reimbursement, and clinical plans will:  Reduce your risk  Optimize your products for the right pre market or post market studies  Optimize your products for the right markets (more than just one market with incremental costs)  Reduce unnecessary testing or research
  • 47.
  • 48.
    48 Clinical » Validation ofSafety and Efficacy work » Typically required by regulators for disruptive products, but not always for incremental products » Global site selection and patient selection criteria are critical » During clinical trial design, reimbursement strategy and “motivation” of KOLs / Sites must be considered » Understand foreign requirements that best treatment after the study to be provided at $0 for chronic indications / or sponsor requirements for treatment costs beyond the standard of care
  • 49.
    49 Clinical » Keep costsdown on clinical trials and consider publication planning in supporting commercial goals but be careful – don’t sacrifice time or approval » Is additional data worthwhile to differentiate, or should this be a post market strategy? » Health Outcomes & Health Economics are here to stay Note: Clinical data is the number one drive of a company’s value. Valid data in today’s healthcare market is critical in getting to market and thriving in the market even if not required for regulatory approval.
  • 50.
    50 Clinical Concept/Feasibility Design Validation / Preclinical ClinicalMarket Approval Post-Market » Clinical data is #1  Watch the stock tickers  Watch the big exit start ups » Maximize the clinical phase – but don’t create unnecessary red flags by trying to do more than is required (marketing and clinical are different things) » Seek strategies (global sites, community hospitals) that impact enrollment and study execution over big name KOLs and Institutes
  • 51.
    51 Market Approval Concept/Feasibility Design Validation/ Preclinical Clinical Market Approval Post-Market
  • 52.
    52 Regulatory Submission » Submittingthe dossier is just the beginning » Several rounds of discussion may be required before acceptance » Regulations on response times are constantly changing (Brazil and EU are changing) » Understand the global agency timetables to reduce risk / optimize your get to market strategy » Is distribution tied to your foreign registration?
  • 53.
    53 Regulatory Approval Concept/Feasibility Design Validation/ Preclinical Clinical Market Approval Post-Market So Your Device is Approved Now What?
  • 54.
    54 Manufacturing Strategy » Beginscaling your manufacturing strategy  Contract manufacturer OR Equipment in house (decision likely made during the feasibility stages)  Scale in step with Distribution Strategies » Optimization of the manufacturing process (still understanding GMP guidelines)  Stability  Process improvements  Compliant  Reproducibility  Document Controls  Product Accountability
  • 55.
    55 Distribution Strategy » Whatis your strategy for commercial adoption? » Significant physician training & KOL development maybe required in international markets, particularly for disruptive products » Conference and Tradeshow adoption strategies
  • 56.
    56 Post-Market » Ongoing clinicalevaluation to further validate patient safety, product efficacy » Collect data to differentiate your technology and pursue product improvement » Collect marketing data to publish and promote product to KOLs » Sales Force Training (direct or indirect) » Physician Training, particularly for first to market & disruptive products
  • 57.
    57 Product Development inSummary » Failure to explore global market opportunities will lead to less than optimal results  Investors / Sr. Management want global strategy » Collaboration across product development life cycle is key to success, it’s not linear, seek partners who know » Alignment of regulatory, reimbursement, testing, quality, clinical, manufacturing, and distribution across the global market strategy is essential (too few companies have this mapped)  Time, cost, burn rates – don’t let the project die! Develop the right milestones for you and your investors » Convincing preclinical and clinical data, ideally linked to positive health outcomes is key to product adoption » No product is alike; regulatory bodies, reimbursement, testing guidelines and market conditions are constantly changing  Customized development strategies must be employed
  • 58.
    58 Thank you NAMSA Headquarters 6750 WalesRoad Northwood, OH 43619 USA Telephone: 866.666.9455 (toll free) +1 419.666.9455 (direct) +1 419.662.4386 (fax) info@namsa.com Tim Blair Director Global Business Development tblair@namsa.com Seth J. Goldenberg, Ph.D. Senior Principal Scientist sgoldenberg@namsa.com