Sunday, April 24, 2016

Making medical devices that customers want

Major challenges influence how the medtech industry works in term of product management, market positioning, and early-stage design and development. From downward cost pressures, reimbursement and regulatory requirements, increased competition, and, internal pressure to generate sales. As easy as it sounds, a customer-centric approach is a difficult thing to accomplish – but it helps medtech companies to think differently, engage with customers differently, and design and market devices differently. Here’re some tips on how adopt this strategy:
Source: MDDI
* Start with the Right Mindset: being a medical device company means that you are in the business of restoring and improving health. “Recognizing that will help you stay focused on making devices customers want and will buy.”
* Get Customer Input the Right Way: don’t just ask what features customers want in your product – ask what outcomes they want from using your product. “It is not the responsibility of customers to figure out what features will provide the experience they desire or achieve the result they want. What customers can meaningfully talk about is what experience and outcomes they want.”
* Minimum Viability, Maximum Value: “Put in just enough features so you validate that what you’re making is viable. Viable means the lean product sufficiently meets a customer need and will sell”.  In the medical sector, this could be harder due to regulatory approvals, reimbursement issues, and clinical trials. However, this is an attempt to minimize both investment and risk to avoid going to market with an expensive, feature-rich product that bombs. Maximum value is all about how much value your product can provide to customers.
         Despite significant barriers to successfully launch a product, this is an industry that exists to save lives – so companies should stay focused on the value, not product features.

Sunday, April 10, 2016

Why medical innovation is so hard

BIOMEDevice Boston conference will happen between April 13-14 and one of the speakers is Bill Betten, director of business solutions at Devicix (Eden Prairie, MN). He recently gave an interview for Qmed about the reasons why medical innovation is so hard to fullfil. “You build around what has been done before. When people hear that statement, they sometimes say things like: ‘what about the implantable pacemaker? Surely that was not incremental?’ But you could argue that the pacemaker certainly built on what came before,” says Betten.
Here are some reasons why leapfrog innovation rarely happens in the medical industry, according to him:
- Financial Constraints: makes it difficult for companies to create breakthrough products or create devices that are less expensive but functionally equivalent to older technology. Due to increasingly cost-conscious hospitals, companies are being forced to reduce costs of their products. “In the past, it was commonplace for device makers to charge substantially more money for new products that only had minor improvements over the previous-generation product. That isn’t the case anymore: many hospitals are now hesitant to invest in new devices that are not demonstrably better than established technologies.”
            Another important point is the vital role of medical device start-ups in developing revolutionary medical technology: one has to add the struggle they go through to obtain venture capital funding for their projects.
- Regulatory Challenges: in a highly regulated industry like the medical sector, product development costs can skyrocket. “Regulatory costs run in the tens of millions of dollars for most 510(k) products, according to a report on AdvaMed’s website. For PMA products, marketing a medical device in the United States can take close to $100 million on average.”

These obstacles are faced by medical start-ups all over the world and Biokyra is no exception. The Brazilian-based company is currently developing medical devices in the vascular area, going through regulatory processes and filing Brazilian and international patents.