Is your organization struggling to stay on top of regulatory issues, access funding, or accelerate new product development? If so, you are not alone. A recent survey of senior medical device executives considered these to be the top 3 challenges their companies are facing in 2015. A heightened regulatory environment combined with a risk-averse investment community are forcing medical device companies to prioritize product innovations that drive cost-effective outcomes in addition to clinical benefits.

Emerging technologies such as 3-D printing and mHealth applications represent exciting opportunities. But to capitalize on these new technologies, medical device firms must rethink their approach throughout the product lifecycle – from concept through post-market surveillance – to incorporate reimbursement strategies, cyber security risk assessments, data transparency and regulatory compliance into product development workflows.

How will you tackle this much change? Investing in digital technologies can help.  Read on to learn about the top 5 med tech trends including guidance on each trend’s impact to your business and how digital can help you stay ahead of the game.

  1. 3-D Printing

Why it’s trending: Truly personalized medicine means that devices will be right-sized for each unique patient’s needs. Applications for 3-D printed devices include wearables, prosthetics such as splints and braces, and orthopedic and dental implants.

What’s different: Devices manufactured using 3-D printers may require additional or different testing and quality controls than products produced using traditional manufacturing techniques, in order to comply with regulatory and reimbursement requirements.

How digital helps: New products – 3-D printed devices included – won’t be skirting the watchful eye of the FDA. From development to manufacturing and ultimately prescribing these products to patients, you’ll get to market faster when your quality, manufacturing, and patient-facing documents are fully digital.

Example use cases: site audits, quality agreements, ePrescriptions

  1. mHealth

Why it’s trending: According to a recent report, more than 500 million smartphone users are expected to be using mobile health apps this year, and that number is projected to climb over 3x to more than 1.7 billion by 2018. These applications range from health and fitness gadgets to mobile biosensors that gather biometric data used in diagnosis and treatment.

What’s different: While consumer wearables like FitBit and Garmin Connect can get to market faster since they are not subject to regulatory approval, regulatory agencies and payers are more interested in applications that demonstrate real value in the currency of health outcomes. New technologies have the potential to change the paradigm for diagnostics and home healthcare – but before they get to market they must be evaluated based on their clinical and cost effectiveness. Gaining both regulatory and formulary approval – not to mention to physicians’ endorsements –will require extensive testing and compelling data around patient impact.

How digital helps: Digital workflows simplify clinical testing and collaboration, such as using electronic signatures for patient data and clinical trial documents instead of dealing with paper. Open data initiatives such as the AllTrials petition support sharing clinical trial data and reporting across companies to improve research and remove publication bias.

Example use cases: statistical analysis plan, product indications, CDRH Premarket review submission

Going digital also removes the cost of paper and manual processes like printing, scanning, and faxing, saving valuable dollars that can instead be invested in additional innovation.

  1. Reimbursement

Why it’s trending: Payer support is crucial for the success of your products – but securing formulary approval isn’t getting any easier. Payers are increasingly looking for the economic benefits of new devices and evaluating how they will produce cost-effective outcomes, creating a higher bar for device reimbursement.

What’s different: To combat these reimbursement challenges, it is increasingly important to craft your reimbursement strategy in parallel to your regulatory and clinical strategies.

How digital helps: Digital processes for payer approval documents will make it easier to collaborate and exchange information with these crucial parties.

Example use cases: Clinical payment approval, Medicaid registration, Medicaid/best price rebates

  1. Cyber-security

Why it’s trending: Recent security breaches in the headlines are forcing all organizations to re-examine security policies and procedures. As medical devices become increasingly interconnected and interoperable, device security is increasingly at risk.

What’s different: The FDA now recommends that manufacturers consider cyber security risks as part of new product design and development. And with growing investment in the Internet of Things (IoT), patients and physicians expect vendors to protect their sensitive health information. The cloud-based technologies, networked devices and mHealth applications that are fueling rapid innovation are also increasing the complexity of information management. While these innovations are key to staying competitive, it will also be critical to effectively mitigating the risks of cybercrime throughout the product development cycle.

Example use cases: patient informed consents, clinical patient responses, product development methods, data management plans

  1. Regulatory Affairs

Why it’s trending: According to a recent industry report, regulatory requirements are on the rise while cost-reduction pressures are mounting.

What’s different: Regulatory compliance is not a new issue for med tech. What has changed is the pricing pressure and resulting cost-cutting initiatives that have shrunk Regulatory Affairs (RA) resources. How will your regulatory affairs team handle increasing requirements with a reduced headcount?

How digital helps: Implementing a digital strategy to manage regulatory compliance workflows can increase RA efficiency, reducing operational costs.

Example use cases: training documentation, SOP sign-offs, product alerts, product withdrawal, adverse event reporting

 

Your Digital Guide

Beyond addressing these top trends, digital adoption offers additional benefits for medical device organizations, including reducing cycle time and development costs, maximizing sales productivity, simplifying global collaboration and ensuring document security and availability. Based on our experience working with 11 of the top 15 global medical device companies, we created a guide to help medical device firms transition to a fully digital enterprise.

Click here to begin your digital journey and capitalize on these key trends.

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