For more updates follow Pharmed Intel
For more updates follow Pharmed Intel
A year ago, few people would have associated contract manufacturing with southwestern China, which is far removed from the production centers of China’s coastal cities. But today, anyone paying attention to the notebook industry has learned that the city of Chongqing in southwestern China will soon become a major base for contract manufacturing of notebooks. Hon Hai Precision Industry and two of the four largest notebook ODMs have all decided to locate notebook manufacturing operations in Chongqing, and it has been reported that Hon Hai’s PC factory is already being staffed. But notebooks won’t be the only contract manufactured products in Chongqing, and Chongqing won’t be the only city attracting outsourced manufacturing in southwestern China. And for good reason. Compared with coastal cities, labor and other costs are lower in southwestern China, and its labor supply is more plentiful. Before Hon Hai and the ODMs committed to Chongqing, there was HP, which in 2008 announced plans for a Chongqing plant to produce notebooks and desktop PCs for customers in China. Then in the fall of last year, news broke that Hon Hai began construction of a notebook manufacturing facility in Chongqing (Oct. 2009, p. 4).
In the notebook ODM space, Hon Hai is a relative newcomer, and two of the first-tier notebook ODMs soon made it known that Hon Hai would not be without competition in Chongqing.
Source : https://mfgmkt.com/wp-content/uploads/2015/01/April10.pdf
How far are we from Digital pharma medicines?
Apparently, not very far. According to recent article outlined in Outsourcing pharma, digital medicines are gathering more real time data to present their case of commercialization and scalability.
Leading the trail is company Proteus , who has been in buzz for its ingestible sensor capable of monitoring patient dosage adherence and vital sign tracking post medicine intake.
The company is set on a mission to make patient control and command his treatment even without being present in hospital set up. Now this is called taking control of your own situation.
Proteus also believes that for patient to have more open discussion with healthcare provider, he or she must have access to real time data of how body is behaving to prescribed medicines. This is of prime interest, as it would pave way for personalized treatment at individual level.
Proteus also highlights the manufacturing view of technology, where company acknowledges that this innovation could be embedded in current manufacturing process with ease. Some amount cross industry knowledge flow would be required though, as digital medicines are hybrid of semiconductor, electronics and pharma products.
Technology and Company: Proteus addresses lot of current market gaps , and we think this innovation is really remarkable and holds tremendous opportunity for company and patients globally.
SO analysis : Strength Opportunity Analysis
Strengths : The company is leading a market which has just begun to explore new possibilities and avenues. With regulatory approvals from FDA and EU agencies company has not just materialized first mover’s advantage but also have bolstered it’s brand image in B2B market.
Opportunities : Ease of platform’s integration with current manufacturing setup highlights the band of potential pharma clients that Proteus can approach in coming days. Innovation from Proteus believes in empowering patients and their families, and helping physicians and healthcare systems reduce risk. Now do we need to spell opportunities for intent or goal of this sort ?
Deal is considered one of the major milestone for CRO fraternity as it involves analytical platform that links data from multiple sensors and wearables, analyse collected data & provide real time insights to end users.
Icon’s appetite for embracing innovation has always been on high note, this is very much acknowledged by numerous proof of concept studies that company has carried out in recent past.
This one though seems like match made in heaven – where best in class unite together to address issues pertaining to clinical trial management.
AI & machine learning are no longer fancy words having vivid description and application, it is now a hard-core reality touching new heights in every sector you can think off. Healthcare though has been late embracer of this innovation, it is trying to run really fast to make up for the lag.
Medical device companies generally enjoy gross margins anywhere in the range of 40% to 75%. Which means their spend (COGS) lies in the range of 25% to 60%. Though this range seems a little too much we were able to research figures for Orthopedic sector.
Analysis by Avicenne highlights that Orthopedic behemoths operate at best gross margins of 70-75%. Further their spend which is 25% of revenue is divided equally between in-house and outsourced activities.
While the entire medtech OEM fraternity plays at a outsourcing range of 25% as per recent analysis from PMCF, orthopedic has surpassed the outsourcing percentage to 49%. Old data from 2012 indicates for a combined revenue of 34.5 billion USD from orthopedic focused OEMs outsourcing to third party contract manufacturers was close to USD 3.7 billion.
Thanks to below mentioned contract manufacturers who scaled their capabilities to a level, which provided OEMs with confidence to board on outsourcing wagon which is out speeding all its other counter parts.
Further another graph below indicates why outsourcing for overall medical device industry still has good potential in coming days. There are still OEMs who are thinking about utilizing medtech CMOs capabilities for their manufacturing need, and if the CMOs are able to convince the decision makers the change in current 25% number is highly likely.
We are referring CSSi Lifescience’s recently launched medical device CRO. The fully integrated medical device CRO is here impact timelines of regulatory clearance and increase profitability of medtech OEMs, both big and small.
Claims of the company are backed by 250+ filed 510K submissions. CSSi Lifescience provides end to end services and beyond, it assists medical device OEMs in design development, testing, clinical studies and reimbursement.
CSSi LifeSciences™ Drug & Medical Device Commercialization & Medical Device CRO Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. Unparalleled Success from Discovery to Commercialization • Commercialized over 500 new drugs, biologics, medical devices and in-vitro diagnostics • Over 250 medical device 510(k) Class 1-3 submissions with 100% success. • Extensive Orphan, “First in Class,” and “First In” Indication success. • Reduced time to approval by over 600 days. • Over 100 NDA, ANDA and BLA submissions, with 96% success. • Greater than 60 EMA CHMP Marketing Authorizations. • SmartStudyTM design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%. CSSi LifeSciences™ Medical Device CRO has experience navigating regulations in over 100 countries. Often companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e., Class 1-3), specific product claims, and intended use. Our diverse team has many years of medical device commercialization experience, with knowledge that goes beyond published guidance, documents and initiatives. CSSi LifeSciences™ Medical Device CRO aims to impact the timeline of regulatory clearance and increase profitability.
Medical Device Commercialization, Clinical study planning and design, Global Regulatory filing and Representation, Preclinical and clinical studies, Quality Management Systems, CRO, Medical Devices
We are referring to NAMSA’s recent expansion into Chinese markets. NAMSA is the only medical research organization that offers support through entire product lifecycle from design to market launch (Company has recently put up a beautiful video on its transition from CRO to MRO, URL: https://www.namsa.com/mro/medical-research-organization/).
NAMSA recently expanded its APAC capabilities by adding 80000 Sq.Ft facility in China. Facility is equipped with technology that helps you across 3 major aspects of product success, these aspects include:
Though the operations of the newly started facility are based out of China, the goal of the facility is to serve as gateway for both domestic and global clients. While domestic healthcare companies can leverage the NAMSA’s capabilities to launch product in China (Almost all regulatory agencies, CFDA inclusive treat NAMSA’s name as synonym to good quality), global companies can extend their relationship with NAMSA to new APAC geographies in terms of launching their innovative products.
We are referring to Freudenbeg Medical’s recently launched products, which were result of 18 months dedicated effort and hard work. Freudenberg Medical’s newly launched product namely Flexseal Introducer Sheath, Flexseal Hemostasis Valve and Composer Deflectable Catheter Handle Platform are creating a lot of noise in minimal invasive solution market.
The trio (three products) are garnering industry’s focus for three reasons
Long story short, if you are Medtech OEM looking to bolster your presence in minimal invasive solution market, and don’t want to delay in reaching desired position, Freudenberg is medtech partner to go for.
It is one of the top innovation partner in medical device contract manufacturing fraternity and can help you with finished goods, design and process solution requirement, all under a single packaging.
We are referring to US Med-Equip’s recent acquisition of Healthcare professional equipment services. US Med-Equip is renowned player in movable medical equipment rental business and asset management; with this acquisition it has further bolstered its presence in US geography.
Healthcare industry is ever changing and requires players, who think outside the box in terms of delivering solution, who embraces the change with minimal issues, and who make best use of available technology to streamline their offerings. US Med-Equip bears all the three accreditations and is favourite partner of 850 hospitals that it currently caters to.
US Med-Equip is committed service provider who uses advanced technologies such as RFID tracking, pro-active PM Management solutions & others as a tech differentiator; this provides company an upper-hand in highly competitive MME rental business.
Below is short snapshot of company capabilities:
Houston-based US Med-Equip is an innovative healthcare company specializing in the rental, sales, and asset management of movable medical equipment for high acuity medical systems. The company has received ISO 9001:2008 certification for its medical equipment management processing system and is widely known for its 24/7 personalized attention to customer needs. In addition, the company is certified as a bona fide Minority Business Enterprise by the National Minority Supplier Development Council. Ranked in 2011 through 2013 by Inc. Magazine as one of the nation’s fastest growing companies, US Med-Equip offers flexible options for managing medical equipment rentals and purchases, maintaining equipment and providing hospitals equipment tracking technology for enhanced asset management. Dedication to patient care and to promoting the healing process is at the core of the US Med-Equip culture and drives daily operations focused on quality healthcare solutions.
Medical Equipment Rental and Sales, Asset Management Solutions, Asset Management & Tracking Software
Hospital & Health Care
7028 Gessner Rd. Houston, Texas 77040 United States
We are referring to EmbedTek LLC’s recent entry into finished goods supply of medtech devices.
EmbedTek LLC has been for long delivering its services to medical device industry; however those service were limited to component level. Post getting FDA badge of contract manufacturer, it can now cater to finished good supply, which means, EmbedTek can now ship ready to use medical devices to OEMs doorstep.
EmbedTEK has shed its previous image of outsourcing partner working on client specs, and has become strategic CMO ready to take joint responsibility of product quality and delivery.
EmbedTek designs and manufactures embedded computers and integrated display solutions for original equipment manufacturers and ISVs. We leverage our expertise in computing, displays, software, wireless, I/O and controls to provide solutions optimized for our customers. We collaborate with our customers early in the process to create solutions that make their end product better. We leverage open standards and augment with engineered hardware and software solutions that enhance the performance of our customers’ end product. We also provide ongoing supply chain management services; delivering the product to our customer throughout the lifecycle proactively managing component obsolescence and product quality. The team at EmbedTek is experienced, professional, agile and customer focused.