How Information Technology is Driving Patient Centricity

In healthcare technology, manufacturing, medical device by Generis0 Comments

Phani_Bidarahalli“The role of IT is vital in driving People/Patient centric solutions. The need for interoperability for home health devices and hospital based information systems will drive the next generation of healthcare IT.”

– Phani Bidarahalli, GM & Global Head, Healthcare, WIPRO

The current health system spend is not sustainable and as a result there is a growing need for more effective, value adding healthcare services.  In recent years healthcare providers have shifted their focus to become more patient and outcome centric in an attempt to achieve the required value for sustainability. Wipro is a multinational Engineering, IT and System integration services company that has been a key partner to some of the largest healthcare organizations and medical device manufacturers in the world. To understand the role that information technology plays in this push for patient-centricity, I sat down with Phani Bidarahalli, GM & Head, Global Practice, WIPRO, to gather some of his opinions and insights.

Phani predicts that “the next wave of innovation in healthcare will center around precision diagnosis and measurable clinical outcomes.” Clinicians are already striving to incorporate information produced by medical devices into their decision-making processes, and with the growth of big data  we will see more and more “researchers collect and harvest data to identify patterns and develop algorithms to narrow down on disease signatures and develop better clinical pathways.”

Cloud based infrastructure is also providing the unique opportunity for healthcare organizations and medical device manufacturers to provide seamless access to data and information regardless of physical location. Emerging markets have been taking advantage of mobile technologies and cloud based infrastructures to provide remote health services to under-served areas that “are extremely challenged in terms of  physical proximity to clinicians and hospital infrastructure.” explains Phani. As such cloud based infrastructure “will play [and is already playing] a very important role in providing access to healthcare technology to promote healthier living.”

Another factor driving patient-centric care is the rise of at-home health monitoring and management systems.  Phani informed me that, through these at-home technologies, “people are experiencing ‘connected-ness’ in their everyday lives more than ever before,” and “home will form a natural extension of hospitals for patients.”  This increased “connected-ness” and proliferation of at-home devices will result in the creation of mass amounts of data outside of the clinical setting that can be used to inform population health and future investments in the health system. Phani notes that “with the increased proliferation of such systems, medical device manufacturers will need re-invent themselves to develop simple, reliable and  nimble devices which are easy to use and have high connectivity.”

As big data analytics becomes more widely utilized, the medical device industry will need to adjust and introduce more products “whose competencies are based on big data.” Which will mean that “the traditional device manufacturing firms will have to develop rich data schemes to not only collect data but also aid in decision making.” Phani advises that, in order to survive in this shifting environment, “device manufacturers will need to foster strong strategic partnerships to enhance productivity and invest better in their core competencies.”

Despite the exciting possibilities that these new technologies present,  Phani predicts that healthcare providers and device manufacturers will prioritize “security and patient privacy as extremely important.”

To hear more about the integrating patient centricity into device manufacturing, attend the American Medical Device Summit 2015, taking place in Chicago on September 21st -22nd, 2015.

The Emerging Challenges for Medical Device Manufacturers: An Interview with Maetrics

In healthcare technology, manufacturing, medical device, mfg by Generis0 Comments

Edward_TomlinsonMaetrics is a global, full service life sciences consultancy firm that has worked with 4 of the top 5 medical device companies, 8 of the 10 top pharmaceutical companies and 6 of the top 10 biomanufacturing companies.

Given Maetrics’ breadth of experience and expertise, I wanted to sit down with Edward Tomlinson, Managing Director of Maetrics, to hear his opinions on the challenges that medical device manufacturers and the industry as a whole will face in the years ahead.

So Edward, how would you say the medical device industry is progressing as a whole? 

By any financial method of analysis the industry is doing very well. It is growing faster than pharmaceuticals, there continues to be a robust series of mergers/acquisitions and as the global population both grows and ages there is an ongoing upturn in the addressable market for their products. Adoption of technologies such as mobile or e-Health and 3, or 4-D printing promises many new avenues of treatment.

However not everything is all roses. The regulatory agencies around the world are increasing their level of oversight in all areas from product development and approval through manufacturing, sales and marketing practices and post launch patient safety monitoring. Further, the revenue and margin from product sales is increasingly dependent on patient outcomes. In order to protect their market position companies need to not only improve their financial performance to avoid becoming a takeover target but must also up their game in product development, compliance and safety to avoid any quality related liabilities.

What  factors could potentially effect industry growth in this sector?

If post-merger companies fall victim to some of the same problems we have seen in the pharmaceutical and biotech sector then we will see a downturn in the productivity of the development groups and difficulty achieving the promised synergies by any means other than significant headcount reductions.

There is also the risk of disruptive technologies – for example, if someone invents a polio vaccine, there is no longer a market for iron lungs, or if bariatric surgery does, indeed, cure type II diabetes then the market for blood sugar testing, insulin pumps and all the devices that go along with cardiac and circulatory issues will also go away. As electronic technologies such as cell phones, remote monitoring etc., become more established we may see many more unexpected disruptions to traditional diagnostic and treatment models.

What do you feel are the most pressing challenges that medical device manufacturers are facing today? 

Complexity and proliferation.

What we mean by that is the complexity of the products with a wide variety of materials, sophisticated design, on board electronics etc., is extremely difficult to manage from a design and change control perspective, not to mention field service! This is compounded by the sheer number of SKU’s that large companies must manage. As more and more of this information enters the public domain, e.g. via the FDA’s UDI ruling the ability of firms to stay on top of product configuration information over the life cycle of the product is critical. Post merger companies need to be able to adopt a “standard model” approach to capturing and maintaining product related information. These companies have well defined post merger integration plans and spend a lot of effort to consolidate financial reporting systems but rarely invest in areas quality and compliance related areas such as supplier, product definition or complaints management.

What are some of the challenges that manufacturers face when it comes to managing supplier and CMO relationships?

The end to end process of determining first to outsource some (or all!) manufacturing through supplier/contractor selection and approval and forward though multiple batches of product has many competing perspectives. Procurement and SCM want low cost, on time highly flexible supplies, QA wants product that meets specs and maintains long term stability studies and Compliance wants minimal risk.

Negotiating a Supplier Agreement that embodies and addresses all of these competing priorities is a challenge, but when all is said and done the agreement is only “words”. The real test is how well the supplier complies with both the intent and spirit of the agreement. There is a great deal to be said for the “trust but verify” model. Multi-day CMO site visits are expensive and time consuming. Companies who use multiple CMO’s need to develop highly sensitive Risk Assessment methodologies to inform decisions regarding survey or desk audits vs. ion site and in person audits.

To find out more about overcoming the current and emerging challenges, and to hear more from Maetric’s Managing Director, Edward Tomlinson, check out the American Medical Device Summit taking place in Chicago on September 21st-22nd, 2015.

Speaker eBook: Q&A with the Speakers at the American Medical Device Summit 2015

In business, generis group, medical device, medtech, q&A by Generis0 Comments

There is less than one month to the American Medical Device Summit 2015! With the event on the horizon, we took a moment to gather some of our key speakers and asked them to share their insights and opinions on the current state and future outlook of medical devices in the U.S. We posed the following questions:

1. How would you describe the current landscape for medical devices in America?

2. What are some of the biggest challenges that companies are facing when bringing medical devices to market?

3. How can these challenges be overcome?

4. When it comes to medical device inception, development or commercialization, what is the one piece of advice you wish that someone had given you?

CLICK HERE to view the Speaker eBookcover screen shot

10 Reasons US Manufacturers are Choosing Mexico

In Uncategorized by Generis0 Comments

Mexico is ranked 3rd out of five high-growth markets (along with Brazil, China, India and Russia) and it is fast becoming a go-to destination for US manufacturers.  The country’s regional proximity lends it an upper hand when compared to these other high-growth regions; with both cultural ties and the NAFTA corridor connecting Mexico to major American markets.

In the past 15 years Mexico has entered over 12 free trade agreements giving preferential treatment to 49 markets on 3 continents.  The low labour and utility costs have enticed a number of manufacturers to pursue Mexico as an option that is more cost effective, while still providing the full range of necessary support services (legal consulting administrative, outsourcing, call centres etc.).

To help define why Mexico is fast becoming the destination of choice, we asked our friends at CPI Co-Production to share the top 10 reasons that they have seen manufacturers choose Mexico over other high-growth regions.


For more insights into medical device manufacturing, and to find out more from CPI-Coproduction, join us next month at the American Medical Device Summit 2015 taking place in Chicago.