In a recent article on massdevice.com, Brad Perriello shares interesting data from Pricewaterhouse Coopers’ (PWC) US Pharmaceutical and Life Sciences Deals Insights Quarterly report Medical device mergers and acquisition deals in the first quarter fell from eight in the Q1 of 2012 to seven in Q1 of 2013. The same time comparison had the total value dropping from $2.3 billion down to $1.7 billion. Dimitri Drone from PWC purports that this decline is not necessarily reflected of the true deal activity. Active and not yet closed deals are not included in these numbers and Drone says “There’s a lot of talk about M&A among the people we interact with in medical devices.” The report still forecasts a growth overall in medical device M&A activity for 2013. What do you think? Are you seeing more of an appetite for deals? To review the PWC report, click here, and for the full article click here.
New study finds that physicians contribute to discovery of new medical devices
A recent study published in the May issue of Medical Care found that medical device startup companies founded by physicians developed roughly the same number of patents as non-physician founded startups. The study, conducted by Drs. Sheryl Winston Smith, PhD and Andrew Sfekas, PhD of the Fox School of Business at Temple University, focused on high-risk, class III medical devices which require substantial testing to prove safety and effectiveness. The study used an algorithm to examine the overlap between premarket approval applications and patents, which is important for identifying which patents are more important for developing new ideas. However, the researchers indicated that conflict of interest policies may result in fewer startups, if regulations are too tight. To read the full article on EurekAlert.org, click here.
FDA suggests international consortium of cardiovascular registries
FDA is calling for an international consortium of cardiovascular registries to coordinate data from multiple disease registries for use in testing the efficacy and safety of medical devices per a recent article on RAPS.org. Patient registries have been used in the past to help regulators manage data from common diseases, as well as gather information to help guide clinical trial expectations. FDA’s international cardiovascular consortium model is based on the International Consortium of Orthopedic Registries (ICOR), which also links various member registries. According to FDA, the registry would serve to “allow for broad-based analysis and surveillance of medical device exposure and related clinical outcomes.” FDA is planning to hold a workshop to gain public input on the proposal and discuss how to implement the plan. To read the full article on RAPS.org, click here.
What do you think of the FDA proposal? Contact us at 317-899-9341 for help with your clinical trials.
Repeal of the medical device tax gains Congressional support
On April 9, 2013, Stephen J. Ubl, president and CEO of AvaMed praised Congress for supporting the repeal of the medical device tax. Ubl stated that device manufacturers are paying an estimated average of $194 million per month in medical device payments, and the tax payments could potentially take money away from R&D for new products and new jobs. To read more of Ubl’s statement, click here. Contact us at 317-899-9341 for help with medical device regulatory filings.
FDA to issue guidance on mobile medical devices
According to a recent article on Pharmatimes.com, the FDA plans to issue guidance describing which medical apps on mobile devices will be subjected to FDA approval. With the advent of multiple new medical apps, the FDA plans to regulate mobile devices that perform jobs done by medical devices that already require FDA clearance or approval. According to Christina Foreman, director of the FDA’s device evaluation division, the goal of the regulation is to “foster technological innovation,” while ensuring that the apps are safe for the public. The FDA does not plan to regulate wellness apps, such as pedometers or heart-rate monitors. To read the full article, click here. Need help getting your medical device approved? Contact us at 317-899-9341.
Health Canada issues a medical device final rule
Health Canada issued guidance on March 4, 2013 entitled “Factors Influencing the Classification of Products at the Device-Drug Interface” which finalizes the guidelines for classification of therapeutic devices or drugs. The focuses of the guidance were to clarify what constitutes a drug or device and support a more standardized regulatory process. To read the final guidance, click here. Contact us at 317-899-9341, if you need assistance with your medical device submission.
Health Canada to accept only electronic submissions
In an effort to reduce the costs, Health Canada announced that it is only accepting administrative regulatory submissions in either electronic common technical document (eCTD) format or as a Portable Document Format (PDF) file beginning June 1, per a recent article on in-pharmatechnologist.com. Use of the electronic submission system will make the documents immediately accessible to Health Canada staff and will help improve efficiency within the process. Security issues are not expected to be a problem, as the regulatory body has “a secure electronic viewing and storage tool for drug submissions which has been successfully used for over 5 years,” according to William Wells of Health Canada. To read the full article, click here.
FDA issues new draft guidance to clarify medical recalls from product enhancements
FDA recently issued draft guidance, entitled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.” The guidance was issued to clarify when a change in a medical device product warrants a recall. Additionally, the guidance distinguishes and defines a product enhancement from a product recall. FDA is accepting comments until May 23, 2013. To read the full draft guidance, click here. To read a related article, click here. Need help with a medical device submission? Please contact us at 317-899-9341 to help with your submissions.
IMDMC March Event
The Indiana Medical Device Manufacturer’s Council (IMDMC) is hosting an event featuring a panel of experts on the legal implications of the new Sunshine Law.
Topic: Sunshine Law Final Rule: How to Ensure Compliance
When: March 27, 2013
Where: Montage Meeting Facility, 8580 Allisonville Pointe Blvd, Indianapolis, IN
Cost: Members: $125 Nonmembers: $175
For more information and to register, click here.
INpact Meeting: February 21, 2013
Join medical device professionals at the February INpact meeting for pizza and local beer.
What: INpact Medical Startup Meetup
When: Thursday, February 21, 2013 at 5:30pm
Where: Speak Easy, 5255 Winthrop Avenue, Indianapolis, IN
Price: $15
For more information and to register, click here.
